Recall Z-2650-2016— Medtronic Inc., Cardiac Rhythm and Heart Failure

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, initiated 2016-08-12, terminated 2017-01-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.. Reason: 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant..

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

Classification

Class II

Status

Terminated

Initiated

2016-08-12

Terminated

2017-01-20

Firm location

Mounds View, MN, United States

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