BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC VR

    MDR report key: 1223424 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03653
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    August 12, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    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 D4 - RELIABILITY LABORATORY TECHNICIAN. JUDE MEDICAL CRMD RELIABILITY LABORATORY FAILURE (EVENT) OBSERVED DURING ANALYSIS UPON INTERROGATION ON THE BENCH, IT WAS FOUND THAT THE DEVICE WOULD NOT COMMUNICATE DUE TO MEMORY CORRUPTION. IT WAS FOUND THAT THE DEVICE ENTERED INTO HWVVI MODE IN 2006, DUE TO A POR. THE CURRENT DRAW OF THE DEVICE WAS MEASURED AND FOUND TO BE NORMAL. THE CAUSE FOR THE MEMORY CORRUPTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-197 NA

    Patients

    Seq Age Sex Outcome Treatment
    1