BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO TEMPORARY PACING LEAD

    MDR report key: 9243283 · Received October 26, 2019

    Report

    Report Number
    3013472601-2019-00004
    Event Type
    Malfunction
    Date Received
    October 26, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BIOTRACE MEDICAL, INC.
    Product Code
    LDF
    UDI-DI
    10866899000203
    PMA / PMN Number
    K160260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) HOSPITAL CONTACTED BIOTRACE MEDICAL AND COMMUNICATED THAT THEY HAD EXPERIENCED A CASE WHERE THEY HAD AN ISSUE WITH STABILIZER RETRACTION: "I HAVE A TEMPO WIRE THAT THE STABILIZERS DID NOT RETRACT WHEN THE MD WAS REMOVING THE WIRE." THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037437 TEMPO TEMPORARY PACING LEAD TEMPORARY PACING LEAD LDF BIOTRACE MEDICAL, INC. T1106 31158 10866899000203

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR