BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY DR, U1.6 DF1 US

    MDR report key: 7035490 · Received November 15, 2017

    Report

    Report Number
    2938836-2017-33953
    Event Type
    Death
    Date Received
    November 15, 2017
    Date of Event
    October 18, 2017
    Report Date
    November 15, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Removal / Correction Number
    2017865-08/28/17-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN. HOWEVER, DURING THE EXPLANT PROCEDURE, THE PATIENT WENT INTO RESPIRATORY ARREST DUE TO AN ANESTHESIA ERROR AND DECLARED TO BE BRAIN DEAD. THE PATIENT WAS MONITORED IN THE CARDIOVASCULAR INTENSIVE CARE UNIT. THERE WAS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. THERE WAS NO PLAN FOR DEVICE EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812978 FORTIFY DR, U1.6 DF1 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CD2231-40 3325978

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death| H| R