BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35 CM

    MDR report key: 14637324 · Received June 8, 2022

    Report

    Report Number
    2183787-2022-00035
    Event Type
    Death
    Date Received
    June 8, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 23, 2022
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    00821329900211
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN PERFORATED THE MYOCARDIUM WHILE REMOVING THE PASSAGERE ELECTRODE AND LATER PIERCED THE LV WHILE PLACING THE GREATBATCH MEDICAL LEAD WITH THE TROCAR THAT WAS BEING USED FOR ACCESS. ACCORDING TO THE DOCTOR, THE TISSUE OF THE HEART WAS VERY SOFT. PHYSICIAN ATTEMPTED TO STOP BLEEDING AND SEW OVER THE PERFORATION, WHICH UNFORTUNATELY DIDN'T WORK. PATIENT DIED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155772 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35 CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511211 W6735784 00821329900211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death