BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 3210499 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03286
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 13, 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 Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE WITHIN EXPECTED LIMITS. HOWEVER, RAPID DEPLETION FROM ERI TO EOS WAS OBSERVED. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED TEST SYSTEM AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE RAPID DEPLETION FROM ERI TO EOS WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ERI. PREMATURE BATTERY DEPLETION IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311121 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention