BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 3080083 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00933
    Event Type
    Injury
    Date Received
    April 26, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. (B)(6). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON THE AVAILABLE PARAMETER AND USAGE INFORMATION, A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND HIGH INPUT CURRENT WAS OBSERVED ON THE HYBRID. THE HIGH INPUT CURRENT WAS CAUSED BY AN ANOMALOUS COMPONENT ON THE HYBRID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180828 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention