BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO TEMPORARY PACING LEAD

    MDR report key: 9038803 · Received September 13, 2019

    Report

    Report Number
    3013472601-2019-00001
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 11, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BIOTRACE MEDICAL, INC.
    Product Code
    LDF
    UDI-DI
    10866899000203
    PMA / PMN Number
    K160260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF THE LEAD FROM THE PATIENT, A PERICARDIAL EFFUSION WAS NOTED ON ECHOCARDIOGRAM. THE EFFUSION DID NOT REQUIRE INTERVENTION. IT WAS OBSERVED THAT THE SOFT TIP OF THE LEAD WAS DETACHED AT THE MIDPOINT OF THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815065 TEMPO TEMPORARY PACING LEAD TEMPORARY PACING LEAD LDF BIOTRACE MEDICAL, INC. T1106 N/A 10866899000203

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other