BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTRACE TEMPO TEMPORARY PACING LEAD

    MDR report key: 9234743 · Received October 23, 2019

    Report

    Report Number
    MW5090643
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 15, 2019
    Manufacturer
    BIOTRACE MEDICAL, INC.
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, A TEMPO WIRE WAS PLACED POST TAVR DUE TO TEMPORARY LEFT BUNDLE BRANCH BLOCK. UPON REMOVAL ON (B)(6) 2019, THE STABILIZERS WOULD NOT RETRACT DESPITE MULTIPLE ATTEMPTS. THE WIRE AND STABILIZERS WERE REMOVED SEPARATELY. AGAIN, OUTSIDE OF THE PT'S BODY, THEY WOULD NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024451 BIOTRACE TEMPO TEMPORARY PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY LDF BIOTRACE MEDICAL, INC. 31158

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR