BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1073483 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02262
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE PREMATURE DEPLETION WAS CAUSED BY AN INTERNAL SHORT WITHIN THE CELL. THE DEVICE TESTED NORMAL AFTER THE CELL WAS REPLACED.

    Description of Event or Problem · 1

    PREMATURE BATTERY DEPLETION WAS REPORTED ON THE DEVICE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-343 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention