BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF4 CONNECTOR

    MDR report key: 3101158 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01949
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS CONFIRMED REPORTED FIELD EVENT OF DEVICE RESET WAS CONFIRMED. THE ROOT CAUSE WAS FOUND TO BE AN ANOMALOUS COMPONENT WITHIN THE HYBRID CIRCUITRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERROGATION OF THE DEVICE PRIOR TO IMPLANT REVEALED BACK-UP VVI MODE. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204103 FORTIFY ASSURA DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1