BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1895844 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04750
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 11, 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
    TN
    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. THE DEVICE WAS ANALYZED WITH A NEW BATTERY AND FOUND TO BE NORMAL. THE ORIGINAL BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION; NO ANOMALY WAS DETECTED. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER HAVING DIFFICULTIES INTERROGATING THE DEVICE AND FINALLY ESTABLISHING TELEMETRY, THE DEVICE REPORTED TO BE IN BVVI MODE. THE DEVICE WAS LATER EXPLANTED, AND IT WAS NOTED THAT THE DEVICE COULD NOT BE INTERROGATED.

    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 64 YR Required Intervention