BEUDAMED
    FDA Recall Terminated

    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

    Recall: Z-2416-2018 · Initiated June 21, 2018

    Recall

    Recall Number
    Z-2416-2018
    Event Number
    80379
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 21, 2018
    Posted
    July 10, 2018
    Terminated
    June 16, 2021
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

    Reason

    Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.

    Action

    On 21-Jun-2018, Medtronic began notifying US follow-up physicians, and Risk Managers of health care facilities of this issue via hand delivery by Field Representatives. In consultation with an Independent Physician Quality Panel, MDT recommends the physicians following patients with affected devices: " Consider scheduling an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps described below. " Use a programmer to ensure the Excessive Charge Time EOL&and the Low Battery Voltage ERI& Patient Alerts have been programmed to On-High " Instruct patients to contact your office if they hear device alert tones. " If this issue has occurred, an EOL: replace device immediately Observation will be displayed on the programmer QuickLook report. Schedule device replacement immediately. The notification provided Patient Management recommendations to ensure patient safety and effective high voltage therapy remain as the device battery voltage approaches its 2.61V ERI threshold.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    103 units