BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS DR

    MDR report key: 1223084 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03763
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 19, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 ENTERED BACKUP VVI STATUS. DEVICE EXPLANT WAS DISCUSSED. THE PATIENT HAS BEEN LOST TO FOLLOW-UP SINCE THIS EVENT.

    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