BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1954717 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00558
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 8, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ANOMALY WAS CONFIRMED IN THE LABORATORY. BASED ON DEVICE SETTINGS THE DEVICE WAS FOUND TO BE BELOW EXPECTED LIMITS. NO HIGH CURRENT DRAIN SOURCES WERE FOUND THROUGHOUT TESTING. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR. AN INTERNAL ANOMALY WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, THE DEVICE WAS FOUND AT END OF LIFE SUDDENLY. PREMATURE BATTERY DEPLETION SUSPECTED.

    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 Required Intervention