BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO TEMPORARY PACING LEAD

    MDR report key: 9176363 · Received October 10, 2019

    Report

    Report Number
    3013472601-2019-00003
    Event Type
    Injury
    Date Received
    October 10, 2019
    Date of Event
    September 12, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BIOTRACE MEDICAL INC.
    Product Code
    LDF
    PMA / PMN Number
    K160260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A PERMANENT PACEMAKER IMPLANTATION PROCEDURE AND DEVELOPED A PERICARDIAL EFFUSION SUBSEQUENT TO REMOVAL OF THE TEMPO LEAD, WHICH WAS KEPT IN THE PATIENT FOR 3 DAYS FOLLOWING A TAVR PROCEDURE. PERICARDIOCENTESIS WAS REQUIRED TO DRAIN THE RESULTING TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968527 TEMPO TEMPORARY PACING LEAD TEMPORARY PACING LEAD LDF BIOTRACE MEDICAL INC. T1106/TC1106 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Life Threatening| R