BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO TEMPORARY PACING LEAD

    MDR report key: 9267971 · Received November 1, 2019

    Report

    Report Number
    3013472601-2019-00005
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 28, 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 REPORTED THAT THEY EXPERIENCED A CASE WHEREIN THE TIP OF THE DEVICE HAD BEEN DAMAGED AND A FRAGMENT WAS MISSING. UPON FURTHER DISCUSSION VIA PHONE, IT WAS COMMUNICATED THAT THE TIP COULD NOT BE LOCATED WITHIN THE PATIENT UNDER XRAY. BTMI ADVISED THAT THE TIP IS RADIOPAQUE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063713 TEMPO TEMPORARY PACING LEAD TEMPORARY PACING LEAD LDF BIOTRACE MEDICAL, INC. T1106 31140 10866899000203

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR