BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 2973406 · Received February 21, 2013

    Report

    Report Number
    2938836-2013-00209
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 11, 2013
    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

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS DUE TO A REPORTED TELEMETRY ANOMALY. THE DEVICE WAS TESTED ON THE BENCH AND WAS FOUND TO BE NORMAL. TELEMETRY DURING BENCH TESTING WAS NORMAL. THE CAUSE OF THE FIELD EVENT WAS DUE TO THE LVAD THAT WAS NOTED TO HAVE BEEN USED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. IT WAS NOTED THAT PATIENT HAD LVAD AT TIME OF IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75517 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR