BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 3943919 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13496
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 10, 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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE ATP AND HV THERAPY FOR AN SVT VIA MERLIN.NET. THE DEVICE WAS SCHEDULED TO BE REPROGRAMMED DURING THE PATIENTS NEXT SCHEDULED APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421213 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR