Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Adrenal disorder, Device alarm issue, Device infusion issue, Drug withdrawal syndrome, Nausea
Clinical narrative: Case number PHHY2014US145408, is an initial spontaneous report from a consumer (patient) via a company representative received on 29 Oct 2014 and forwarded by another agency (License Partner Number: ADR 2014 02052) on 07 Nov 2014; with a follow up report received from a healthcare professional (company representative) on 06 Jan 2015 and forwarded by the agency (License Partner Number: ADR 2014 02052) on 09 Jan 2015. This report refers to a 56 year old female patient. Medical history included failed back surgery syndrome and device system implanted on 09 Mar 2010. The patient received intrathecal compounded baclofen (manufacturer unknown) 50mcg/ml for the treatment of non malignant pain from an unknown date at a dose of 25.978 mcg/day. The patient also received intrathecal hydromorphone (manufacturer unknown) 05mg/ml for the treatment of non malignant pain at a rate of 2.5978 mg/day, intrathecal bupivacaine (manufacturer unknown) 05mg/ml for an unknown indication at a dose of 2.5978 mg/day and DILAUDID (manufacturer unknown) 05 mg/ml for an unknown indication at a dose of 2.5978 mg/day, all from an unknown date. The patient had an electric wheelchair but she had it for a while. The patient was not aware of any magnetic fields that had been near the pump. On an unknown date, the patient experienced symptoms of nausea and vomiting and had been in the hospital approximately 01 month prior to the report and the symptoms were attributed to an adrenal gland issues. The patient also had a influenza virus vacc seasonal inn on 27 Oct 2014 and had nausea and issues due to the flu shot per the patient. The patient reported that she did not hear the alarm. It was noted that the patient also had a stimulator device. The patient experienced repeated pump motor stalls. The oldest log in the event logs was from 27 Oct 2014 which was a motor stall recovery at 17:22. The patient presented to the office on 29 Oct 2014 to have the pump refilled and the nurse noticed the attention dialogue box when she interrogated the pump. When the drug was aspirated from the pump on 29 Oct 2014, the healthcare professional (HCP) was supposed to receive 05 ml back but got back close to 08 ml. There were multiple motor stalls and motor stall recoveries that made up all of the event logs, other than an update that occurred on 29 Oct 2014. On an unknown date, the patient developed adrenal disorder and vaccination complication. The patient presented to the HCP office stating loss of pain relief and other vague symptoms. Upon interrogating the pump it was noted that the pump had stalled and recovered several times. The company representative met with the patient 02 days later and saw the same phenomenon. The pump was continuously stalling and recovering. As a result the patient was not receiving any drug. The nausea and vomiting that the patient initially experienced was thought to be related to withdrawal possibly from not getting drug from the pump. Once the  patient began receiving oral medical (unspecified) these symptoms went away. The patient suffers from many other health issues that are not at all related to the pump and the patient was currently not able to be cleared for surgery. It was further noted however, that once the patient was cleared the pump would then be replaced. Action taken with the suspect drugs was not reported. The outcome of the events nausea and vomiting was reported as complete recovery (symptoms went away) while for the other events was not reported. The seriousness of the events was reported as serious (hospitalization and medically significant) by health care professional. The causality of the events was not reported. Follow up report received from a company representative on 06 Jan 2015 and forwarded by the agency (License Partner Number: ADR 2014 020520 on 09 Jan 2015: Update dose of baclofen, bupivacaine, add new suspect DILUADID, added new events (adrenal disorder, vaccination complication, loss of pain relief, withdrawal) with seriousness, outcome of the events (nausea and vomiting) and updated the narrative. Following an internal review done on 13 Jan 2015, for the data received on 06 Jan 2015, following significant case correction was performed: Added influenza virus vacc seasonal inn (as a co suspect).