BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 8448537 · Received March 25, 2019

    Report

    Report Number
    3013472601-2019-00002
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    February 26, 2019
    Report Date
    March 20, 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

    THE TEMPO, TEMPORARY INTRACARDIAC PACING LEAD, WAS PLACED IN THE RIGHT VENTRICLE DURING A TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE. THE PATIENT EXPERIENCED HEMODYNAMIC COLLAPSE PRIOR TO INSERTING THE TAVR VALVE. A PERICARDIAL EFFUSION WAS DETECTED ON THE INTRAOPERATIVE ECHO CARDIOGRAM AFTER THE HEMODYNAMIC COLLAPSE. THE PATIENT WENT TO SURGERY AND A PERFORATION IN THE RIGHT VENTRICLE WAS REPAIRED AND THE AORTIC VALVE WAS SUCCESSFULLY PLACED. THERE WERE NO LASTING INJURIES NOR PERMANENT IMPAIRMENT AS A RESULT OF THE EVENT. UPON RETURN TO BIOTRACE MEDICAL INC. A FORMAL DEVICE INVESTIGATION WAS CONDUCTED WHEREIN THERE WERE NO MANUFACTURING, NOR FUNCTIONALITY ISSUES DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243281 TEMPO TEMPORARY PACING LEAD LDF BIOTRACE MEDICAL INC. T/TC1106 N/A

    Patients

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