BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC COVIDIEN FLEXON PACING LEAD

    MDR report key: 8868966 · Received August 5, 2019

    Report

    Report Number
    8868966
    Event Type
    Death
    Date Received
    August 5, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    LDF
    UDI-DI
    8886258963
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT STATUS POST CORONARY ARTERY BYPASS GRAFTING TIMES TWO. NO POST OPERATIVE COMPLICATIONS, READYING FOR DISCHARGE AND EPICARDIAL PACING WIRES PULLED ON POD 3, PT ALMOST IMMEDIATELY SUFFERED CARDIAC ARREST AND DID NOT RECOVER DESPITE CHEST RE-ENTRY AND OPEN CARDIAC MASSAGE IMMEDIATELY AFTER ARREST. THIS EVENT WAS THE SECOND OF TWO EVENTS INVOLVING DEATH AFTER REMOVAL OF EPICARDIAL PACING WIRES WITHIN DAYS OF EACH OTHER, THEREFORE REPORT WAS GENERATED FOR FDA AND MFR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656322 MEDTRONIC COVIDIEN FLEXON PACING LEAD EPICARDIAL PACING WIRES LDF MEDTRONIC COVIDIEN UNK UNK 8886258963

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death