Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271

FDA device recall Z-0812-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Managment

Reason for recall

Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.

Action taken

A letter, dated April 2004, was sent on April 5, 2004 to physicians following patients who had the defibrillators implanted. The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem. Physicians are being visited by sales representatives to verify notification.

Root cause

Other

Status

Terminated

Product code

LWS

Quantity affected

250 units (34 units in the United States)

Distribution

Nationwide in the United States and worldwide.

Date initiated

2004-04-02

Date posted

2004-07-20

Date terminated

2005-11-29

Location

Fridley, MN