BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 3220392 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04131
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 2, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER UPON RECEIPT. LOW BATTERY VOLTAGE WAS OBSERVED. A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND HIGH CURRENT DRAIN WAS OBSERVED. THE CAUSE WAS DETERMINED TO BE POOR CONNECTIONS TO THE CAPACITORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT REPORTED TO THE CLINIC DUE TO A VIBRATORY ALERT. INTERROGATION SHOWED PREMATURE BATTERY DEPLETION. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321012 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention