BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 3943933 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13424
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    May 30, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, IT WAS NOTED THE BATTERY LONGEVITY HAD DECREASED SINCE THE PREVIOUS FOLLOW-UP. REVIEW OF THE SESSION RECORDS REVEALED POSSIBLE INCORRECT DISPLAY OF REMAINING LONGEVITY. THE CURRENT LONGEVITY ESTIMATE IS SHORTER THAN EXPECTED. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423707 FORTIFY VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1