BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS VR

    MDR report key: 1073024 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02274
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 20, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE (EVENT) OBSERVED DURING ANALYSIS. UPON INTERROGATION ON THE BENCH, THE DEVICE WAS DETECTED IN HWVVI. THE DEVICE REVERTED INTO HWVVI DURING CHARGING TO HIGH VOLTAGE FOR A CARDIOVERSION THERAPY. THE DEVICE WAS REMOVED FROM HWVVI, AND IT PERFORMED NORMALLY ON BENCH TESTING. THE CAUSE OF THE HWVVI WAS UNDETERMINED.

    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 ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1