BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR

    MDR report key: 3220160 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04425
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 10, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    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. THE REPORTED FIELD EVENT OF NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS ABLE TO ESTABLISH SUCCESSFUL COMMUNICATION WITH THE PROGRAMMING USING INDUCTIVE TELEMETRY, HOWEVER, WAS UNABLE TO ESTABLISH COMMUNICATION USING RF TELEMETRY. THE DEVICE WAS TESTED ON THE BENCH AND AN RF MODULE ANOMALY WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE BOX, THE DEVICE COULD NOT BE INTERROGATED PRIOR TO IMPLANT. INTERROGATION WITH ANOTHER PROGRAMMER WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321212 FORTIFY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1233-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1