BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL VR

    MDR report key: 3903632 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12843
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 26, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INABILITY TO COMMUNICATE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO PREMATURE BATTERY DEPLETION. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. 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 AN INTERNAL BATTERY ANOMALY WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO THE HOSPITAL WITH HOT SENSATION ORIGINATING FROM DEVICE LOCATION. PATIENT WAS SENT HOME WHEN NO ISSUES WERE FOUND. TWO DAYS LATER, PATIENT RETURNED WITH DEVICE STILL GENERATING HEAT. NO COMMUNICATION COULD BE ESTABLISHED WHEN AN ATTEMPTING TO INTERROGATE THE DEVICE. TWO DIFFERENT PROGRAMMERS WERE USED TO ATTEMPT TO INTERROGATE THE DEVICE BUT WERE UNSUCCESSFUL. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380738 CURRENT ACCEL VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention