BEUDAMED
    FDA Enforcement Class II Terminated

    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).

    Recall: Z-2651-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2651-2016
    Event ID
    74923
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    August 12, 2016
    Classification Date
    August 24, 2016
    Termination Date
    January 20, 2017
    Address
    8200 Coral Sea St NE, Mounds View, MN, 55112-4391, United States

    Description

    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.

    Code Info

    Product Name: Evera XT DR lCD. Models: DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1. Serial Numbers: BWC202738H, BWC202754H, BWB202998H, BWB203157H, BWB203167H, BWB203173H, BWB203186H, BWE601558S, BWE601571S, BWE601578S, BWE601579S, BWE601581S, BWE601589S, BWE601591S, BWE601594S, BWE601600S, BWE601605S, BWD602122S. Product Name: Evera S DR lCD. Models: DDBC3D1, DDBC3D4. Serial Numbers: BWG600597S, BWF600969S, BWF600970S, BWF600972S, BWF600973S, BWF600975S, BWF600977S, BWF600978S, BWF600979S, BWF600983S, BWF600984S, BWF600985S, BWF600987S, BWF600989S, BWF600991S, BWF600992S, BWF600996S, BWF601001S. Product Name: Evera XT VR lCD. Models: DVBB1D1, DVBB2D4. Serial Numbers: BWI201423H, BWI201436H, BW1201440H, BWI201451H, BWI201454H, BWI201462H, BWI201473H, BWJ601102S, BWJ601108S, BWJ601112S, BWJ601479S, BWJ601101S, BWJ601103S, BWJ601106S.

    Distribution

    Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.

    Quantity

    78 (39 US, 39 OUS)