BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS VR

    MDR report key: 1050927 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01866
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE HOSPITAL WITH INAPPROPRIATE HV SHOCKS FOR AF. DURING INTERROGATION THE DEVICE WAS FOUND TO BE IN HARDWARE BACK UP MODE. THE DEVICE WILL BE EXPLANTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS VR NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1