BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3801270 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10919
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    December 25, 2013
    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
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MERLIN TRANSMISSION SHOWED NON-SUSTAINED LEAD NOISE DUE TO EPISODES OF PREMATURE VENTRICULAR CONTRACTION. REVIEW OF STRIPS FROM TRANSMISSION REVEALED THAT THIS WAS NOT A LEAD ISSUE. PATIENT WAS BROUGHT IN FOR FOLLOW-UP AND PRESENTED WITH COMPLAINTS OF SHORTNESS OF BREATH. THE PACE/SENSE VECTORS OF THE DEVICE WERE CHANGED. THE DEVICE REMAINS IMPLANTED. PATIENT CONDITION IS GOOD AND WILL BE MONITORED ROUTINELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278687 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR