BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 2242430 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06193
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    July 13, 2011
    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 Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED AND DEVICE LONGEVITY WAS FOUND TO BE BELOW EXPECTED LIMITS GIVEN THE AVAILABLE PROGRAMMED PARAMETERS. DEVICE WAS TESTED ON THE BENCH AND NO HIGH CURRENT DRAIN SOURCE WAS FOUND. THE BATTERY WAS SENT TO THE VENDOR. NO ANOMALIES WERE FOUND THAT WOULD CAUSE THE BATTERY TO DEPLETE. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS SEEN IN-CLINIC AND REPORTED A REMAINING LONGEVITY OF (B)(6). ON (B)(6) 2011, THE DEVICE WAS BELOW EOL. SESSION RECORDS SHOW NO THERAPY DELIVERY SINCE (B)(6). DEVICE WAS EXPLANTED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention