BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO TEMPORARY PACING LEAD

    MDR report key: 9949237 · Received April 10, 2020

    Report

    Report Number
    3013472601-2020-00002
    Event Type
    Injury
    Date Received
    April 10, 2020
    Date of Event
    March 11, 2020
    Report Date
    April 9, 2020
    Manufacturer
    BIOTRACE MEDICAL, INC.
    Product Code
    LDF
    UDI-DI
    00866899000203
    PMA / PMN Number
    K160260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) REPORTED THAT THEY HAD AN ISSUE WITH THE RETENTION OF THE BLACK CONNECTOR LEAD DURING THE PROCEDURE (BECAME DISCONNECTED FROM THE PACING GENERATOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411513 TEMPO TEMPORARY PACING LEAD PACING LEAD LDF BIOTRACE MEDICAL, INC. T1106 N/A 00866899000203

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R