BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 420462 · Received October 1, 2002

    Report

    Report Number
    2938836-2002-00407
    Event Type
    Injury
    Date Received
    October 1, 2002
    Date of Event
    August 15, 2002
    Report Date
    August 15, 2002
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ST. JUDE REP PHONE TO REPORT THAT, WHEN COMMANDED, THE DEVICE DID NOT INTERNALLY DUMP THE HV CAPACITORS FROM THE INDUCTION SCREENS. THERE WAS OVER 300V REMAINING ON THE CAPS FROM THE LAST TIME THE DEVICE CHARGED. WHEN SEVERAL ATTEMPTS WERE MADE TO DUMP THE RESIDUAL CAPACITOR VOLTAGE VIA A HVLIC, OTHER FIBER OPTIONS AND A POP-UP WINDOW WOULD APPEAR STATING THAT THE ATTEMPT TO DUMP THE VOLTAGE WAS UNSUCCESSFUL. INDUCTION TESTS COULD NOT BE PERFORMED. EXPLANT WAS RECOMMENDED BY ST. JUDE TECHNICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM LWS ST. JUDE MEDICAL, INC., CRMD V-199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other THERAPY DATES: NA.