BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 2242452 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06617
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 7, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    THE DEVICE LOST COMMUNICATION DUE TO BATTERY DEPLETION. THE BATTERY DEPLETION WAS CAUSED BY MULTIPLE CHARGES AND NOISE REVERSION ALERTS FROM HEAVY EMI EXPOSURE. THE NOISE SIGNALS WERE CONSISTENT WITH EXPOSURE TO MRI. A LONGEVITY CALCULATION FOUND THE DEVICE TO BE WITHIN EXPECTED ESTIMATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP WITH A DEVICE THAT WAS FOUND TO BE IN BACKUP VVI MODE WITHOUT DEFIB SUPPORT. SINCE SEPTEMBER, THE DEVICE HAS BEEN EXPOSED TO A MRI. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention