BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1831057 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03630
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 29, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE'S BATTERY VOLTAGE WAS FOUND TO BE LOW, AND CAUSED A POWER-ON-RESET. A LONGEVITY CALCULATION WAS PERFORMED AND THE DEVICE WAS FOUND TO BE OUTSIDE OF THE EXPECTED LIMITS. THE DEVICE'S ELECTRONIC CIRCUITRY WAS TESTED BOTH MANUALLY ON THE BENCH AND ON THE AUTOMATED ELECTRICAL SYSTEM. NO ANOMALIES WERE FOUND. THE BATTERY WAS SENT TO THE VENDOR FOR ANALYSIS. AN INTERNAL BATTERY ANOMALY WAS FOUND, WHICH CAUSED THE PREMATURE BATTERY DEPLETION REPORTED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IN HARDWARE RESET MODE (HWVVI) WITH NO VF THERAPY. THE PATIENT DID NOT HAVE ANY EXTERNAL DEFIBRILLATION THERAPY, RADIATION OR MRI. THE PATIENT DID NOT FEEL ANY VIBRATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    THE LEAD DISLODGED AGAIN AND WAS EXPLANTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention