BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR

    MDR report key: 2242598 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06536
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    June 7, 2011
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE WAS FOUND TO BE IN RESET MODE. THE CAUSE OF RESET COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4). FAILURE (EVENT) OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTIFY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1