AL05-013 June 8, 2005

**Item: Guidant Model 1861 Ventak Prizm 2 DR, Implantable
Cardioverter-Defibrillators (ICD) manufactured before November 2002**

### General Information: Guidant Corporation submitted voluntary advice to physicians, by letter on May 23, 2005, about an unpredictable breach of an insulator in the device. This insulator defect could result in at least partial diversion of current in the high-voltage output circuitry, thereby preventing the device from delivering high-voltage shock therapy when ventricular tachycardia or fibrillation is detected. This random component failure can occur in any Model 1861 ICD manufactured before November 13, 2002.

**Specific Incident:** Guidant reported that there have been 26 cases
exhibiting the above failure mode from 37,000 devices implanted
worldwide. In one of those cases, the patient may have died when the
device failed to deliver high-voltage shock therapy.

**Actions:** 1. Within two weeks, electrophysiology/cardiology staff or
other appropriate parties must identify all affected patients by
implementing each of the following steps a through d. **It is important
that ALL INFORMATION sources be reviewed to insure that patients will
not be missed, as they may be found on one list and not on another.**

a\) Review the manufacturer's letter (attached).

> b\) Review the patient list posted on the VA National ICD Surveillance
> Center intranet website
> ([https://icd.sanfrancisco.med.va.gov](https://icd.sanfrancisco.med.va.gov/)).
> This list, provided by Guidant, consists of all the VA patients in the
> company's database that have an implanted model 1861 ICD which had
> been manufactured prior to November 13, 2002 and VA patients having
> this implant that are being followed at a VA facility.

c)  Review the VA National registry for ICD implants Washington VAMC,
    point of contact is <Ronald.Jones1@va.gov>.

d)  Review your patient records for all patients with implanted Guidant
    model 1861 Ventak Prizm 2 DR, ICD devices.

> 2\. Within the next 45 calendar days, interrogate all Guidant Model
> 1861 ICDs for "no telemetry" or "warning screen" conditions. These
> conditions indicate that the ICD may be inoperative. If one of these
> conditions is present, replace with a suitable new device.
>
> a\) If the interrogation of the Guidant model 1861 ICD does not reveal
> a problem, the patient should be followed at the manufacturer's
> recommended intervals of every 3 months.  However patients should be
> instructed to return immediately for device interrogation following
> any shock delivery, and ICD replacement should be considered at that
> time.

3\. Follow the actions contained in Attachment 2. This guidance was
prepared by Dr. Edmund Keung of the VA National ICD Surveillance Center
as the best course of action for your patients.

**Additional Information**: See Guidant website
[www.guidant.com](http://www.guidant.com/)

**Source:** Guidant Corporation.

**Contact:** Dr. Edmund Keung at VA National ICD Surveillance Center at

> \(415\) 221-4810 Extension 3182 Or
>
> Mr. Bryanne Patail at National Center for Patient Safety (NCPS) at
> (734) 930-5890

**ATTACHMENT 1**

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height="9.018055555555556in"}

**ATTACHMENT 2**

+---+----------+---------------------+------------------------+---+---------+
| ! |          | **DEPARTMENT OF     |                        |   |         |
| [ |          | VETERANS AFFAIRS**  |                        |   |         |
| ] |          |                     |                        |   |         |
| ( |          | **Medical Center**  |                        |   |         |
| m |          |                     |                        |   |         |
| e |          | **4150 Clement      |                        |   |         |
| d |          | Street**            |                        |   |         |
| i |          |                     |                        |   |         |
| a |          | **San Francisco CA  |                        |   |         |
| / |          | 94121**             |                        |   |         |
| i |          |                     |                        |   |         |
| m |          | **VA National ICD   |                        |   |         |
| a |          | Surveillance        |                        |   |         |
| g |          | Center**            |                        |   |         |
| e |          |                     |                        |   |         |
| 2 |          |                     |                        |   |         |
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+---+----------+---------------------+------------------------+---+---------+

June 1, 2005

Dear colleagues:

This document is to provide you with more technical information on the
issue involving the Guidant Model 1861 Ventak Prizm 2 DR ICD
performance.

(A) **The Problem:**

    -   The ICD can fail to deliver shock of any magnitude when it
        detects ventricular tachy arrhythmias (VT or VF). The occurrence
        is **random**.

> In order for the problem to occur, the following 4 events have to
> occur:

1.  The wire (which acts as the negative pole) has to position close
    enough to the tube in the header that is filled with the inert gas
    (which is the positive pole)

2.  There has to be a breach of insulation on the wire

3.  There has to be a variation in the adhesive that is between the tube
    and the wire

4.  The shock has to jump from the negative pole to the positive pole to
    short out the can

-   The problem does not occur during cap reform. Normal cap reform does
    not have predictive value.

    -   The history of the ICD performance has no predictive value. A
        device can provide successful shock yesterday and fail to
        deliver shock today when VT/VF are detected. Similarly, doing a
        successful defibrillation test has no predictive value.

-   The bottom line: There is no way to predict which device will have
    this problem. Routine follow-up will not disclose the problem. The
    only way to find out is when the patient needs a therapeutic shock
    (and it fails)!

**(B) Try to identify as many affected patients as possible. There are
several sources:**

> \(1\) The list of your affected patients that has been provided by
> your local Guidant representative.
>
> \(2\) Bryanne Patail, the biomedical engineer for the VA National
> Center for Patient Safety obtained a list of 225 patients from
> Guidant. These patients had either a model 1861 ICD manufactured prior
> to November 13, 2002 implanted or are being followed at a VA facility.
> You can go to the VA National ICD Surveillance Center website
> ([\<https://icd.sanfrancisco.med.va.gov\>]{.underline}) to search for
> your own patients. **Please remember, this list is not complete. There
> are likely to be patients who are being followed in your clinics and
> not on this list.**
>
> \(3\) Washington DC VAMC maintains a national registry for ICD
> implants. Mr. Ron Jones can help you with your search.
> <Ronald.Jones1@va.gov>
>
> \(4\) Your own local database. This is the best, if you have one.

**(C) What to do?**

Guidant does not recommend replacement of the devices. We have to weigh
the incidence and consequence of battery failure against potential
complications with generator replacement. The incidence of circuitry
failure is low, at 1 in 2000 (0.05% or 0.002% per service month).
However, if it fails, the result can be catastrophic for the patient. In
patients with a history of frequent shock therapy or who are totally
pacemaker-dependant, device replacement may be considered. We have to
evaluate individual patient's clinical conditions, discuss the situation
with the patients and arrive at the best course of action.

Ed Keung, MD

Ph: 415-221-4810, extension 3182

Edmund.Keung@med.va.gov

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