FDA Device

GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)

Hazard

Extended charge times prior to defibrillation shock.

What You Should Do

Remedy

An 'Important Patient Management Information' letter, dated November 14, 2002, was sent to physicians following patients who had the defibrillators implanted and this gave recommendations to physicians to prevent the problem.

Products

GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
UPC
All serial numbers beginning with PIM4. The serial number have the form of PIM4xxxxxx.

Units Affected

2539 devices