BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA ST VR, DF-4 CONNECTOR

    MDR report key: 4760316 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04636
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    March 11, 2015
    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 THE PATIENT RECEIVED AN ALERT FOR NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING. THE ALERT WAS DETERMINED TO BE FALSE, CAUSED BY INTERMITTENT LOSS OF CAPTURE. OCCASIONAL LOSS OF CAPTURE WAS PRESENT EVEN AT VOLTAGES WELL ABOVE THE CAPTURE THRESHOLD. NO FURTHER ACTION WAS TAKEN BECAUSE THE PATIENT IS NOT PACEMAKER DEPENDENT. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305266 FORTIFY ASSURA ST VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1359-40QC NA

    Patients

    Seq Age Sex Outcome Treatment
    1