BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II VR

    MDR report key: 3080174 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01028
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 12, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REVERTED TO HARDWARE BACK UP MODE WITHOUT DEFIB SUPPORT AFTER STEREOTAXIS PROCEDURE. THE PATIENT ELECTED NOT TO CHANGE OUT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182699 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR