BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 4760298 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04657
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    February 20, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED INTO THE EMERGENCY ROOM WITH DYSPNEA AND FATIGUE. THE PATIENT RECEIVED UNSUCCESSFUL ATP THERAPY FOR A SLOW VT RESULTING IN INAPPROPRIATE RETURN TO SINUS. AFTER THE DELIVERY OF SEVERAL ATP THERAPIES AND ONE HIGH VOLTAGE THERAPY THE PATIENT WAS REVERTED. THE DEVICE WAS REPROGRAMMED. PATIENT MONITORING WILL CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305197 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR