BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR

    MDR report key: 4153562 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16444
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, THE PHYSICIAN FOUND AN EPISODE OF VF NOT DEFIBRILLATED BY THE DEVICE. A VT EPISODE WAS DIAGNOSED IN THE VF ZONE. PATIENT RETURNED TO SINUS AFTER AN EXTERNAL DC SHOCK. DEFIBRILLATION THRESHOLD TESTS WERE PERFORMED WAS ABLE TO TERMINATE THE VF EPISODE. THE PATIENT WAS GOOD DURING AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632279 FORTIFY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1233-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR