BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 1954712 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00571
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 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 Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. COMMUNICATION WAS ESTABLISHED AFTER ORIGINAL BATTERY WAS REMOVED AND DEVICE WAS POWERED USING AN EXTERNAL POWER SUPPLY. AUTOMATED ELECTRICAL TESTING WAS PERFORMED. THE DEVICE FUNCTION WAS NORMAL. NO SOURCES OF HIGH CURRENT DRAIN WERE FOUND. THE BATTERY WAS RETURNED TO THE SUPPLIER FOR FURTHER ANALYSIS. THE CAUSE OF PREMATURE BATTERY DEPLETION WAS DUE TO AN INTERNAL ANOMALY WITHIN THE BATTERY.

    Description of Event or Problem · 1

    IT WAS REOPRTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention