Abstract:
A medical device includes an alert to signal that the amount of stored data is approaching the capacity of the memory in the medical device, and the data must be uploaded to avoid losing the data. A patient perceptible alert may trigger the patient to influence immediate/timely action for data transmission. A silent alert may trigger automatic data transmission, or trigger a medical support network to autonomously conduct transmission of the data.

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S)  
       [0001]     This application claims the benefit of U.S. Provisional Application No. 60/589,249 filed on Jul. 20, 2004, for “Device Memory Upload Trigger” by P. DeGroot. 
     
    
     INCORPORATION BY REFERENCE  
       [0002]     The aforementioned U.S. Provisional Application No. 60/589,249 is hereby incorporated by reference in its entirety.  
       BACKGROUND OF THE INVENTION  
       [0003]     The present invention relates to an improved medical device that minimizes loss of data stored in the memory of the medical device.  
         [0004]     Various medical devices gather and store data in a memory located within the device. The data that is gathered is useful for proper patient management, or it may be important for clinical investigations.  
         [0005]     Implantable medical devices (IMDs), such as pacemakers, cardioverter/defibrillators, drug delivery devices, and nerve stimulators are designed to be as small as possible while encasing all necessary components. This necessitates the use of low power components, so that the IMDs can be operated for extended periods of time without battery replacement. Current IMDs, therefore, make use of low voltage, low current memory components that have limited storage capacity.  
         [0006]     A problem experienced by those that manage patients or perform clinical investigations on patients with IMDs is that data gathered by the IMDs is routinely lost. Patients are regularly scheduled to upload the data stored in their IMDs. However, in many instances, the amount of data gathered exceeds the limited storage capacity of the IMD&#39;s memory. As the memory overfills, it is typically configured to write over the earliest data stored in the device memory. This continues until the data is uploaded, at which time the memory may be cleared.  
         [0007]     In many cases patients are not aware of relevant clinical events as they occur. Data related to these events are continuously gathered and stored by the IMD, but the patient is not aware that the amount of stored data is approaching or has reached the capacity of the memory. As a result, data may be lost, with neither the patient nor a caregiver being aware of the quantity or content of the data.  
       BRIEF SUMMARY OF THE INVENTION  
       [0008]     The present invention is a system that reduces the loss of data stored in a medical device. A processor within the medical device initiates an alert when the amount of stored data approaches the capacity of the memory of the device. The alert signals the need to transmit the data stored in the memory of the medical device to a medical support network thus enabling a safety alert to preserve data. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]      FIG. 1  is a schematic diagram of a representative system utilizing the present invention.  
         [0010]      FIG. 2  is a schematic diagram of a representative system utilizing the present invention.  
         [0011]      FIG. 3  is a block diagram of an implantable medical device.  
         [0012]      FIG. 4  is a block diagram of a monitor.  
         [0013]      FIG. 5  is a block diagram of a patient management network.  
         [0014]      FIG. 6  is a flowchart illustrating the present invention.  
     
    
     DESCRIPTION  
       [0015]      FIG. 1  illustrates a representative system by which data from a medical device is gathered by a medical support network. System  10  includes patient P with implantable medical device (IMD)  12 , portable external device  14 , communications link transceiver  16 , medical support network  18 , phone lines  20 , communications link satellite  22 , and global positioning system (GPS) satellite  24 .  
         [0016]     IMD  12  is shown here as an implantable medical device, however, the medical device may also be external rather than implantable. External device  14  is portable and carried with patient P and communicates with IMD  12  by wireless signals. External device  14  communicates with communications link transceiver  16 , again, by wireless signals. Transceiver  16 , in turn, communicates with medical support network  18  via phone lines  20 . However, any of a number of forms of communication of data may be used. External device  14  may communicate with medical support network  18  via communications link satellite  22 . Lastly, external device  14  may also communicate with GPS satellite  24 .  
         [0017]     In operation, physiological data of patient P and operational data of IMD  12  are gathered and stored in the memory of IMD  12 . Typically, patient P is scheduled to transmit the data stored in the memory of IMD  12  at regular intervals. The transmission of data occurs remotely through this system such that patient P is not required to make an in-office visit to a caregiver.  
         [0018]     Triggering data upload from IMD  12  may occur by any of a number of different ways. Patient P may initiate uploading of data via external device  14 . Communication between medical device  12  and external device  14  is through wireless signals such as radio frequency (RF) signals. External device  14  subsequently transmits the data to medical support network  18  via alternative pathways. In a first pathway, the data is transmitted to communications link transceiver  16  by wireless communication. The data is then sent to medical support network  18  over phone lines  20 . In a second pathway, the data is transmitted by wireless communication to medical support network  18  via communications link satellite  22 .  
         [0019]     Alternatively, uploading of data may be initiated via a signal generated from medical support network  18 . The signal can be sent to external device  14  through either of the pathways described above.  
         [0020]     As shown in  FIG. 1 , portable external device  14  carried or worn by patient P. However, as shown in system  26  in  FIG. 2  monitor  28  may also function as an external device in place of or in addition to portable external device  14 . Only part of system  26  is shown and described. Here, monitor  28  is utilized instead of external device  14 , but device  14  and monitor  28  provide the same functions. Monitor  28  utilizes telemetry with range suitable for communicating over appropriate distances, and is kept in any area where patient P will regularly come into range of monitor  28 . The telemetry protocol defines the distance and may require close proximity to a programming head to facilitate indicative communications to longer distances of a few feet to e.g., 30 feet of course, when properly supported telemetry would be facilitated over even great distances and is not meant as a limiting factor. In this embodiment, communication between stationary device  28  and medical support network  18  is, for example, via a hard-wired phone line. Uploading of data from medical device  12  is initiated as described above for external device  14 . However, transmission of data from IMD  12  using system  26  only occurs while patient P is within range of monitor  28 .  
         [0021]     The memory of IMD  12  has a limited capacity for storing data. The amount of stored data may surpass the memory&#39;s capacity before patient P is scheduled for uploading data from IMD  12 . As the data overfills the memory, new data typically writes over the initial data, and the initial data is lost.  
         [0022]     IMD  12  is a device such as a pacemaker or defibrillator that is implanted in patient P and is capable of providing life-saving and life-enhancing cardiac therapies. These therapies may include providing pacing pulses or defibrillation shocks to the heart of patient P or providing drug therapy. IMD  12  also records useful data related to the condition of patient P and IMD  12  and periodically provides that data to a caregiver. In addition, IMD  12  is capable of detecting the occurrence of an event that satisfies predefined alert criteria. The alert criteria pertain to either a clinically-relevant event, such as an arrhythmia, or to the functioning of IMD  12  and are guidelines determining when to attract the patient&#39;s and/or caregiver&#39;s attention. Once an event is detected that satisfies an alert criterion, IMD  12  is capable of providing a patient perceptible alert and/or a silent alert. A patient perceptible alert notifies patient P of a triggered alert criterion via, for example, an audible tone (or mechanical vibration, electric shock, olfactory signal, etc.) from IMD  12 , device  14 , or monitor  28 . A silent alert is a caregiver or network  18  notification of a triggered alert criterion via system  10  or  26 .  
         [0023]     Monitor  28  is a device, such as the Medtronic CareLink monitor, intended for use in a patient&#39;s home that is capable of receiving data from the patient&#39;s implanted device via telemetry and transmitting this information via phone lines or other communication link to a private network, which transfers the data to network  18 . In one embodiment, the private network is the IP Link service from MCI, which provides a private, secure, and reliable connection.  
         [0024]     Network  18  utilizes secure computer servers that collect, process, and store data sent from monitor  28  or device  14 . This information is available to patient P and a caregiver through patient management web clients. Patient management web clients are computer systems with a browser capable of viewing web pages on the World Wide Web.  
         [0025]     There are at least three follow-up scenarios in which a caregiver can interact with IMD  12  to monitor the condition of patient P and IMD  12 : standard follow-up, remote follow-up, and ambulatory follow-up. Standard follow-up is a scheduled face-to-face interaction between patient P and a caregiver in order to check the patient&#39;s health/status and the functioning of IMD  12 . Typically, the standard follow-up occurs every three to six months. System  10  or  26  of the present invention reduces the number of standard follow-ups that need to take place. The remote follow-up is a scheduled electronic transmission of the data stored in IMD  12  to a caregiver in order to check the health of patient P and the functioning of IMD  12 . Similar to the standard follow-up, the remote follow-up typically occurs every three to six months. The remote follow-up is enabled by use of monitor  28  or device  14  and network  18 . The ambulatory follow-up is an unscheduled and IMD-initiated electronic transmission of the data stored in IMD  12  to a caregiver in order to alert the caregiver to the occurrence of an event that satisfies the alert criteria to allow a caregiver to check the status of patient P and the functioning of IMD  12 . Standard follow-ups may be time-consuming, inconvenient, and often unnecessary for both patient P and the caregiver. Ambulatory follow-ups, however, can be provided by system  10  or  26  of the present invention to provide many benefits.  
         [0026]     System  10  or  26  of the present invention is capable of providing remote follow-ups as well as silent alerts for ambulatory follow-ups. Communication between the various components of system  10  or  26  will now be described. Either upon the detection of the amount of stored data approaching the capacity of the memory, or at a scheduled time, IMD  12  is interrogated by monitor  28  or device  14  over a wireless telemetry system utilizing RF signals. Monitor  28  or device  14  then communicates the data to network  18  from the home of patient P. Data is then displayed to the caregiver or patient P using patient management web clients utilizing the standard World Wide Web (“WWW”) secured communication protocol (i.e. SSL).  
         [0027]     System  10  or  26  increases the caregiver&#39;s efficiency in managing, from his or her office, patient P from the patient&#39;s home; while also increasing the caregiver&#39;s ability to identify and react to clinical conditions and disease management issues. System  10  or  26  reduces reliance on the memory of patient P to upload data before it is lost and on the awareness of patient P that clinical events are occurring.  
         [0028]     The present invention can also be utilized in clinical trial studies. It is useful to have as much data as possible retained during clinical trials to ensure that important data is not lost. An alert indicating that the amount of stored data is approaching the capacity of the memory reduces the loss of data.  
         [0029]      FIG. 3  is a block diagram of IMD  12  of system  10  or  26  of the present invention. Although it is recognized that system  10  or  26  can be used with any type of implantable medical device, a specific example will now be provided in which IMD  12  is an implantable cardioverter/defibrillator (ICD). IMD  12  includes leads  30 , pacing circuitry  32 , defibrillation circuitry  34 , sensors  36 , control processor  38 , telemetry processor  40 , transmitter circuitry  42 , receiver circuitry  44 , antenna  46 , speaker drive circuitry  48 , speaker  50 , and memory  52 .  
         [0030]     Control processor  38 ′ is the primary controller for the overall operation of IMD  12 . Specifically, control processor  38  controls pacing circuitry  32  and defibrillation circuitry  34  to provide therapeutic electrical pulses to leads  30 . Leads  30  are preferably implanted within the heart of patient P and provide an electrically conductive path for the pulses to selected locations within the heart. In addition, leads  30  can be used by sensors  36  to detect cardiac signals in the heart. Together, leads  30  and sensors  36  are a means for sensing physiological parameters. These cardiac signals are conducted through leads  30 , detected by sensors  36 , and then provided to control processor  38 . Control processor  38  saves the signals in memory  52 , which is, for example, random access memory (RAM).  
         [0031]     Control processor  38  is capable of analyzing the cardiac signals received from sensors  36  and monitoring the condition of IMD  12  to determine, among other things, whether the amount of data stored in memory  52  is approaching the capacity of memory  52 . Control processor  38  is a means for activating an alert. If control processor  38  determines that the amount of data stored in memory  52  is approaching the capacity of memory  52 , it then decides, based upon caregiver selectable alert settings, what type of an alert should be provided. If the caregiver selectable alert settings instruct control processor  38  to provide a patient alert, an alert signal is generated and sent to speaker drive circuitry  48 . Speaker drive circuitry  48  provides the necessary electrical signal to speaker  50  to generate an audible sound that alerts patient P that the amount of stored data is approaching the capacity of memory  52 , and data from IMD  12  should be uploaded.  
         [0032]     On the other hand, if caregiver selectable alert settings instruct control processor  38  to provide a silent alert, then an alert signal is generated and sent to telemetry processor  40 . The circuitry required to generate, initiate, or activate an alert may be referred to as alert circuitry. Telemetry processor  40  then controls transmitter circuitry  42  to emit an RF alert signal that is transmitted wirelessly over antenna  46 . The alert signal alerts external device  14  ( FIG. 1 ) or monitor  28  ( FIG. 2 ) that IMD  12  is set to communicate with it, provided that external device  14  or monitor  28  is within the telemetry range of IMD  12 . Transmitter circuitry  42  is also a means for transmitting data stored in the memory. In this way, IMD  12  is capable of initiating communication with external device  14  or monitor  28  to inform device  14  or monitor  28  that the amount of stored data is approaching the capacity of memory  52 .  
         [0033]     Control processor  38  may detect that the amount of stored data is approaching the capacity of memory  52  by any of a number of methods. In a representative embodiment, control processor  38  is instructed to alert when data is saved at a specific address in memory  52 . The specific address correlates to the amount of stored data that approaches the capacity of memory  52 .  
         [0034]     It is recognized that IMD  12  could be utilized to provide an alert signal in response to any detectable event to avoid loss of recorded data. Other events may include therapy delivery, arrhythmias, heart failure, system integrity, ischemia, or a neurologic or neurocardiogenic event such as an epileptic seizure.  
         [0035]      FIG. 4  is a block diagram of monitor  28  of system  26  of the present invention. All or some of the same components are also used by external device  14  of system  10 . Monitor  28  includes communication system  54 , wireless communication system  56 , patient alert module  58 , control switches  60 , digital signal processor (“DSP”)  62 , real-time clock (“RTC”)  64 , memory  66 , modem  68 , and power supply  70 . Short-distance communication system  54  includes antenna  72 , receiver circuitry  74 , and transmitter circuitry  76 . Wireless communication system  56  includes antenna  78 , transmitter circuitry  80 , and receiver circuitry  82 . Patient alerts include speaker  84 , speaker drive  86 , light-emitting diodes (LEDs)  88 , and LED drive  90 . Control switches  60  include start switch detection  92 , and reset  94 . Memory  66  includes SDRAM  96  and flash memory  98 . Modem  68  includes digital data access arrangement (“digital DAA”)  100 , isolation  102 , line side DAA  104 , RJ11 ports  106  and  108 , tone/pulse select  110 , and prefix select  112 . Power supply  70  includes DC power  114 , reverse polarity protection  116 , overcurrent protection  118 , digital voltage power supplies  120 , and DC outputs  122  and  124 .  
         [0036]     Monitor  28  is preferably located within the home of patient P or otherwise mentioned within proximity to the patient P. Monitor  28  is capable of wireless communication with IMD  12  via wireless communication system  56  over distances facilitated by the selected telemetry protocol. Communication system  54  uses an intermediary device, such as a programming head, placed proximate the IMD to communicate (e.g., via inductive coupling). Wireless communication system  56  permits communication over longer ranges, e.g., from a few feet to 30 feet, or even significantly greater. Short-distance communication system  54 , which communicates over a distance of up to about 25 feet, is also provided to enable communication with implantable medical devices that utilize short-distance head-based communication.  
         [0037]     Patient alert module  58  includes speaker  84  coupled to speaker drive  86  and LEDs  88  coupled to LED drive  90 . Speaker drive  86  and LED drive  90  are both controlled by DSP  62 . Speaker drive  86  and speaker  84  serve two functions: to generate tones to indicate an alert condition, and to make modem  68  audible. LEDs  88  are used as visual indicators to give status indications to patient P or a caregiver during an interrogation and modem connection. LEDs  88  also alert patient P to power status and completion of uploaded data to the server. Switches  60  provide buttons that allow patient P to interact with monitor  28 . Switches  60  include start switch detection  92  and reset  94 . Start switch detection  92  allows patient P to instruct monitor  28  to begin an interrogation of IMD  12 . Reset  94  allows patient P to reset monitor  28  to factory defined settings.  
         [0038]     Real-time clock  64  is provided in monitor  28  to keep track of the time. Both IMD  12  and monitor  28  keep track of the time so that communication can take place at predetermined times. In order to save battery power in IMD  12 , the telemetry system of IMD  12  does not remain active at all times. Instead, IMD  12  and monitor  28  have predefined communication times during which routine communication can take place. However, as described above, system  10  and  26  also include the capability of IMD  12  initiated communication at any time when the amount of stored data approaches the capacity of the memory.  
         [0039]     SDRAM  96  of memory  66  is used to store interrogation data from IMD  12  as well as program code and other program-related data. Flash memory  98  is used to store program data and any parameters that need to be stored in non-volatile memory (e.g. phone numbers). DSP  62  boots from flash  98 .  
         [0040]     Power supply  70  provides DC power to monitor  28 . The function of power supply  70  should be easily understood by one skilled in the art and therefore will not be described in further detail.  
         [0041]     Monitor  28  is an interrogation and data transfer tool used with IMD  12 . Monitor  28  offers the capabilities to patient P, a caregiver, and service personnel of remote interrogations, data processing, reporting and follow-up to be performed when the patient is at home and the caregiver is in the clinic or a location that has web-enabled capability. This remote feature allows for reduced travel and waiting time, providing prompt care to patients and better efficiencies to caregivers. It also enables caregivers to better manage patients and still maintain the quality of care that is warranted in the marketplace. Furthermore, monitor  28  allows field representatives to increase their productivity, provide equal or better service to existing and new customers worldwide, and control costs for providing the services. The increased productivity is obtained by reducing the time required for manufacturer-assisted follow-up. Monitor  28  interrogates IMD  12  and stores the data. Further, monitor  28  collaborates with network  18  to confirm the establishment of a connection with network  18 , performs any required file translation functions necessary for data transfer, and executes the data file transfer and then collaborates with network  18  to confirm that the data file transfer was successful. If external device  14  is utilized, communication between network  18  and device  14  may be via satellite link  22  such as described in U.S. Pat. No. 6,292,698, assigned to Medtronic, Inc.  
         [0042]     Now that the structures of IMD  12  and monitor  28  have been described, the communications between IMD  12  and monitor  28  will be described. As explained above, there are at least three primary follow-up scenarios in which a caregiver and IMD  12  interact: standard follow-up, remote follow-up, and ambulatory follow-up. Of these, a remote follow-up and an ambulatory follow-up utilize monitor  28  as one of the communication links between IMD  12  and the caregiver. A remote follow-up occurs every three to six months at a scheduled time. An ambulatory follow-up, on the other hand, may occur when IMD  12  detects that the amount of stored data is approaching the capacity of memory  52 . Thus, the primary difference between the two follow-up procedures is that in an ambulatory follow-up procedure IMD  12  must initiate communication with monitor  28 , since the communication is not scheduled. A remote follow-up, on the other hand, is scheduled and expected by IMD  12 , and therefore is initiated by monitor  28 . This procedure also satisfies current FCC regulations, which indicate that an implantable medical device operating in the MICS band may not initiate communications unless a “medical implant event” occurs. (Title 47 of the Code of Federal Regulations, Part 95.628.) The FCC has further defined the event as an occurrence that necessitates data exchange in order to maintain patient safety.  
         [0043]     Once communication has been established, monitor  28  typically performs a full interrogation of IMD  12 . Control processor  38  of IMD  12  reads the desired data from memory  52  and then provides it to telemetry processor  40 . Telemetry processor  40  and transmitter circuitry  42  transform the data to an RF signal that is wirelessly transmitted by antenna  46  to monitor  28 . Monitor  28  receives the wireless transmission of data through antenna  78  and wireless receiver circuitry  82 . Receiver circuitry  82  then provides the data to DSP  62 , which stores the data in SDRAM  96 . After all desired data has been received; the communication between monitor  28  and IMD  12  is closed.  
         [0044]      FIG. 5  is a block diagram of network  18  of system  10  or  26  of the present invention. Network  18  includes device data input and interpretation  126 , device data storage  128 , web presentation services  130 , user/web data storage  132 , and core services  134 . Device data input and interpretation  126  includes device data input  136  and device data conversion  138 . Web presentation services  130  include device data presentation  140  and patient management network (“PMN”) content services  142 . Core services  134  include PMN security  144 , PMN print framework  146 , PMN presentation framework  148 , and PMN administration/operational support  150 .  
         [0045]     Network  18  utilizes secure computer servers that collect, process and store data sent from monitor  28 . This data is then made available to patient P and a caregiver through Internet accessible web sites that are personalized for their particular needs.  
         [0046]     After monitor  28  has completed a full interrogation of IMD  12 , it then transfers the data over a telephone line to link  16 . Link  16  is, for example, MCI&#39;s IP Link private network. Link  16  allows monitor  28  to remotely access network  18  over a private, secure, and reliable connection. Network  18 , which consists of secure computer servers, receives the data from monitor  28  (over link  16 ) and into device data input and interpretation  126  and more specifically through PMN device data input  136 , which, in one embodiment, includes a dedicated router. The data is then processed by PMN device data conversion  138  and stored in device data storage  128 . Further processing is performed by web presentation services  130  to turn the raw device data into viewable portable document format (“PDF”) documents, graphs, tables, etc. and also to create client and patient personalized web sites which are accessed by a patient browser and caregiver browser. This data is then stored in user/web data storage  132 . Additionally, core services  134  are performed by network  18  to provide PMN security  144 , PMN print framework  146 , PMN presentation framework  148 , and PMN administration/operational support  150 .  
         [0047]      FIG. 6  is a flow diagram illustrating one embodiment of a method of sending an alert signal from IMD  12  upon the amount of stored data approaching the capacity of memory  52 . IMD  12  begins by monitoring for the occurrence of the amount of stored data approaching the capacity of memory  52  (step  152 ). When this occurrence is detected (step  154 ), the system selects who should first be notified based upon predefined alert criteria. This step is preferably performed by IMD  12  but may also be performed by device  14 , monitor  28 , or network  18 . If IMD  12  decides to attempt a silent alert to a caregiver (step  156 ), IMD  12  wirelessly transmits an alert signal to monitor  28  or external device  14 . If monitor  28  or device  14  receives the alert signal, a full interrogation of IMD  12  is performed as defined above and the session is closed. Monitor  28  or device  14  then transfers the data to network  18 , which informs the caregiver. The system then determines whether the silent alert was successfully communicated to the caregiver (step  158 ).  
         [0048]     Various methods of determining the success of the silent alert may be used. For example, monitor  28  or device  14  can provide a verification signal to IMD  12  after the data is successfully transferred to network  18 , or the caregiver can provide a verification signal to network  18  that is sent through system  10  or  26  to IMD  12 , etc. If system  10  or  26  determines that the silent alert has been received (step  160 ), it knows that the caregiver will take the necessary action (step  162 ). If system  10  or  26  determines that the silent alert failed (step  164 ) (for example, if no verification signal is received within a predetermined amount of time), IMD  12  assumes that the alert was not successfully communicated. As a result, IMD  12  repeats the attempted transmission a predetermined number of times (steps  154 ,  156 ,  158 , and  164 ). Because the most frequent cause of a failed transmission is that IMD  12  is not in range of monitor  28 , IMD  12  waits for a specified amount of time, such as three hours, before retrying the transmission. So, for example, IMD  12  will continue attempting communication every three hours for up to three days for a total of twenty four times.  
         [0049]     If repeated attempts to transmit the alert signal are unsuccessful, IMD  12  will then switch to the backup alarm. The backup alarm may be, for example, patient perceptible signals generated by speaker drive  48  and speaker  50 . Thus, after repeated unsuccessful attempts to wirelessly transmit the alert signal (steps  154 ,  156 ,  158 , and  164 ), a patient perceptible signal is provided (step  166 ). If patient P receives the alert signal, IMD  12  can be designed with a user response device, such as a magnetic sensor, a wireless telemetry input device, or other manual input means, which allows patient P to verify that he or she has received the alert. To do so, system  10  or  26  detects when a full interrogation of IMD  12  has taken place, and recognizes at that point that the patient alert has been received.  
         [0050]     In alternate embodiments, the alert may also be triggered by situations in which the wireless transmission is considered a failure, such as: when the alert signal is not received by monitor  28  or device  14 , when the interrogation of IMD  12  by monitor  28  or device  14  is incomplete, when network  18  does not receive the data, or when the caregiver does not acknowledge the alert after being informed by network  18 .  
         [0051]     System  10  or  26  of the present invention provides a caregiver selectable user interface in which the caregiver can set the caregiver selectable alert settings of system  10  or  26  to perform as desired. These settings define the alert criteria that are used by IMD  12  to determine whether or not an alert should be sent, and whether a silent alert or a patient alert should be sent. Thus, system  10  or  26  provides the caregiver with a user interface in which he or she can select which events should initiate a silent alert, a patient alert, both alerts, or no alert at all.  
         [0052]     System  10  or  26  not only allows the caregiver to enable or disable the alert conditions, but also allows the caregiver to select the response to the condition. If the caregiver selects the alert mode to be “audible,” the alert method is set as a patient alert. If the caregiver selects the alert mode to be “silent,” the alert method will be a silent alert. Finally, if the user selects the alert mode to be “audible+silent,” both methods of notification will be used.  
         [0053]     System  10  or  26  of the present invention provides an alert for memory upload that can be provided to various people based upon caregiver selectable alert settings, thereby increasing the safety and quality of life of a patient. It provides a system and method for transferring data automatically without any interaction by the patient. It reduces the number of times that the patient must travel to a clinic for memory upload, thereby reducing the burden on the patient and increasing the efficiency of the caregiver.  
         [0054]     The system of the present invention includes a number of patient alert methods including a speaker in IMD  12  and a speaker and LEDs in monitor  28 . Other known types of patient alerts may also be used including muscle stimulation, vibration, or olfactory stimulation (in an external device such as monitor  28 ). Similarly, various means of alerting the caregiver (or any other person) are contemplated. An alert may be provided to a device worn or nearby a caregiver such as a telemetry enabled watch, home PC, public access transponder, WiFi/Bluetooth network, telephone, pager, cell phone, or displayed on a programmer during the next interrogation. Alternatively, the alert could be provided to a call center from monitor  28  or network  18 , the call center having an operator who would contact the caregiver. The alerts may include all information from the interrogation of IMD  12 , or it may be simply a message informing the caregiver to check the caregiver website. Furthermore, it is recognized that this alert may be provided for any other device in the system or a system in communication with any device in the system.  
         [0055]     Although systems  10  and  26  of the present invention have been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.