BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO TEMPORARY PACING LEAD

    MDR report key: 9603633 · Received January 17, 2020

    Report

    Report Number
    3013472601-2020-00001
    Event Type
    Injury
    Date Received
    January 17, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BIOTRACE MEDICAL, INC.
    Product Code
    LDF
    UDI-DI
    10866899000210
    PMA / PMN Number
    K160260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DR. (B)(6) WHO PLACED THE TEMPO LEAD STATED THAT HE BELIEVED THAT THE PERFORATION OCCURRED DURING THE INITIAL PLACEMENT OF THE TEMPO LEAD. THIS IS SUPPORTED BY HIS STATEMENT THAT THE TEMPO LEAD WAS PLACED "WAY OUT" TO THE APEX OF THE RIGHT VENTRICLE AND IN SPITE OF THIS TYPICALLY OPTIMAL POSITION, PACE CAPTURE COULD NOT BE ATTAINED. DR. (B)(6) REPOSITIONED THE TEMPO LEAD TWICE AND WAS ULTIMATELY ABLE TO OBTAIN A CAPTURE THRESHOLD BELOW 1MA (GENERALLY CONSIDERED OPTIMAL). SUBSEQUENT TO PLACEMENT OF THE LEAD THE PATIENT WAS NOTED TO BE HYPOTENSIVE, WHICH WAS ULTIMATELY DETERMINED TO BE RELATED TO A PERICARDIAL EFFUSION. SURGERY WAS PERFORMED ON THE PATIENT TO CLOSE A SMALL PERFORATION IN THE APEX OF THE HEART. DR (B)(6) STATED THAT HE USED THE INTRODUCER AID TO ADVANCE THE TEMPO LEAD INTO THE INTRODUCER SHEATH AND THAT HE DID NOT HAVE ANY DIFFICULTY DURING TEMPO LEAD INSERTION OR PLACEMENT. HE STATED THAT THE SOFT TIP LOOKED NORMAL AT THE TIME OF THE FINAL POSITION IN THE APEX OF THE RIGHT VENTRICLE AND WAS NOT KINKED OR "OFFSET". HE ALSO STATED THAT THE PATIENT WAS (B)(6) AND AT RISK OF AN APICAL PERFORATION BY VIRTUE OF HIS AGE AND MORBIDITIES. WHILE THE SOFT TIP OF THE TEMPO LEAD APPEARED TO BE DAMAGED, IT IS NOT KNOWN IF THE DEVICE MALFUNCTIONED OR IF THERE WAS MISUSE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64137 TEMPO TEMPORARY PACING LEAD TEMPO TEMPORARY PACING LEAD LDF BIOTRACE MEDICAL, INC. TC1106 31035 10866899000210

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R