BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 4173875 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16710
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT RECEIVED INAPPROPRIATE THERAPY. MERLIN.NET TRANSMISSION DISPLAYED INTERMITTENT ATRIAL UNDERSENSING OF P-WAVES FALLING ON TOP OF THE R-WAVES AND CAUSING THE RATE BRANCH TO IMMEDIATELY CLASSIFY THE ARRHYTHMIA AS VT. PATIENT WAS PUT ON APPROPRIATED THERAPY DRUG TO CONTROL RAPID ATRIAL FIBRILLATION AND ZONES WERE REPROGRAMMED. THE DEVICE REMAINS IMPLANTED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654564 FORTIFY ASSURA DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention