BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1895920 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04745
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 13, 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

    THE REPORTED COMMUNICATION ANOMALY WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. A CARDIAC SIMULATOR WAS CONNECTED TO THE DEVICE AND THE DEVICE SENSED THE SIGNALS PROPERLY. ALL FUNCTIONAL MEASUREMENTS AND BATTERY CURRENT DRAIN WERE NORMAL. THE DEVICE MET ALL SPECIFICATIONS. IT IS SUSPECTED THAT THE LEAD WAS DAMAGED. THE DEVICE MISDIAGNOSED NOISE AS FIB, CHARGED AND DEPLETED THE BATTERY.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED .

    Description of Event or Problem · 1

    THE DEVICE WAS UNABLE TO BE INTERROGATED. NO TELEMETRY COULD BE ESTABLISHED. THE DEVICE WAS EXPLANTED.

    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 55 YR Required Intervention