BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS VR

    MDR report key: 1223635 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03579
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    August 21, 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

    FAILURE (EVENT) OBSERVED DURING ANALYSIS THE DEVICE WAS TESTED IN THE AUTOMATED ELECTRICAL TEST SYSTEM AND NO ANOMALY WAS DETECTED. THE DEVICE CURRENT WAS MEASURED AND IT WAS NORMAL. THE BATTERY LONGEVITY WAS CALCULATED BASED ON AVAILABLE DEVICE PPARAMETERS AND WAS BELOW THE EXPECTED LONGEVITY PERFORMANCE.

    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