BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 3854590 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11601
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FAR P OVERSENSING WAS OBSERVED ON VIA MERLIN TRANSMISSION. REPROGRAMMING CHANGES WERE MADE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332049 FORTIFY ASSURA DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR