BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT VR

    MDR report key: 3100995 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01832
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE REVEALED THAT THE BACKUP VVI MODE WAS CAUSED BY A POWER ON RESET THAT OCCURRED AFTER ARRHYTHMIA INDUCTION WAS INITIATED. THE FIELD EVENT WAS SIMULATED ON THE BENCH AND NO ANOMALIES WERE SEEN. THE DEVICE WAS TESTED ON THE BENCH AND USING A CARDIAC SIMULATOR AND WAS FOUND TO BE NORMAL. NO ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT THE DEVICE WENT INTO BACKUP VVI RESET WHILE TRYING TO INDUCE VF VIA DC FIBBER. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202932 CURRENT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1107-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1