FDA Device

Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx

Hazard

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.

What You Should Do

Remedy

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.

Products

Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx
Brand
Medtronic Inc. Cardiac Rhythm Managment
UPC
Manufacturing dates from November 1996 to December 1997; and   Use Before Dates from May 1998 to June 1999.

Units Affected

5839 units (2394 units in the United States)