BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1223210 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03714
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 13, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THE DEVICE TO BE OUTSIDE NORMAL LONGEVITY ESTIMATES. VARIOUS INTERNAL VOLTAGE MEASUREMENTS WERE NORMAL. WITH A NEW BATTERY, THE DEVICE WAS TESTED ON THE AUTOMATED ELECTRICAL TEST SYSTEM AND FOUND TO BE NORMAL. THE CURRENT DRAIN ALSO REMAINED NORMAL DURING TESTING. THE BATTERY WAS SENT OUT FOR FURTHER TESTS; HOWEVER, NO ANOMALIES WERE FOUND AND THE ROOT CAUSE OF THE RAPID DEPLETION REMAINS UNDETERMINED. .

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED EXCESSIVE BATTERY DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention