BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 3781746 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09922
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 FIELD EVENT OF AN INABILITY TO COMMUNICATE WITH THE DEVICE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO PREMATURE BATTERY DEPLETION. WITH AN EXTERNAL POWER SUPPLY ATTACHED, THE DEVICE FUNCTIONED NORMALLY. NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND ANALYSIS COULD NOT CONCLUSIVELY DETERMINE A ROOT CAUSE FOR THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. TWO DIFFERENT PROGRAMMERS AND MULTIPLE DIFFERENT WANDS WERE USED BUT COULD NOT ESTABLISH TELEMETRY. THE PATIENT WAS IN A CAR ACCIDENT TWO WEEKS PRIOR, BUT THERE WAS NO KNOWN TRAUMA TO THE DEVICE AREA. DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259647 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention