Recall Z-2651-2016— 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, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only).. 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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