BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 4061884 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15561
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO RECEIVING A NOTIFIER. NON-SUSTAINED RV OVERSENSING DUE TO PROGRAMMING WAS OBSERVED. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541056 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 68 YR