BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC COVIDIEN FLEXON PACING LEAD

    MDR report key: 8868978 · Received August 5, 2019

    Report

    Report Number
    8868978
    Event Type
    Death
    Date Received
    August 5, 2019
    Date of Event
    May 20, 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 FOUR. POST OPERATIVE DAY FIVE, PT WAS BEING READIED TO BE DISCHARGED AND EPICARDIAL PACING WIRES DISCONTINUED. SHORTLY THEREAFTER PT COMPLAINED OF NOT FEELING WELL AND BECAME DIAPHORETIC. HYPOTENSION ALSO DEVELOPED POST-WIRE REMOVAL AND CARDIAC RHYTHM CHANGE NOTED AS WELL. PT BECAME PULSELESS AND ACLS WAS INITIATED, PULSE RETURNED AND PT TRANSFERRED TO ICU WHERE HIS CHEST WAS OPENED AND EPI DIRECTLY DELIVERED TO THE HEART. PT WAS TAKEN TO THE OPERATING ROOM AND WASHED OUT / CLOSED CHEST AND RETURNED TO ICU WHERE HE WAS LATER DIAGNOSED WITH ANOXIC BRAIN INJURY. CARE WAS WITHDRAWN IN COLLABORATION WITH FAMILY ON (B)(6) 2019. THIS EVENT WAS CONSIDERED A RARE BUT NOT UNEXPECTED RISK AFTER REMOVAL OF EPICARDIAL PACING WIRES. OUR FACILITY EXPERIENCED ANOTHER EVENT AFTER REMOVAL OF PACING WIRES SEVERAL WEEKS LATER, THEREFORE THIS EVENT IS BEING REPORTED IN TANDEM WITH THE OTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656308 MEDTRONIC COVIDIEN FLEXON PACING LEAD EPICARDIAL PACING WIRES LDF MEDTRONIC COVIDIEN UNK UNK 8886258963

    Patients

    Seq Age Sex Outcome Treatment
    0 79 YR Death
    1 79 YR Death