BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS DR

    MDR report key: 1831062 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03647
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 4, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    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 PATIENT WAS BROUGHT TO THE EMERGENCY ROOM. THE DEVICE WAS INTERROGATED AND A MESSAGE OF BACKUP VVI MODE WAS OBSERVED. THE PATIENT IS IN THE INTENSIVE CARE ROOM, INTUBATED AND VENTILATED WITH POSSIBLE CEREBRAL DAMAGE. IT WAS STATED THAT THE PATIENT WAS SHOCKED SEVERAL TIMES BY AN EXTERNAL DEFIBRILLATOR, CAUSING POSSIBLE DAMAGE TO THE DEVICE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR