BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM

    MDR report key: 10944905 · Received December 4, 2020

    Report

    Report Number
    2183787-2020-00093
    Event Type
    Death
    Date Received
    December 4, 2020
    Date of Event
    September 8, 2020
    Report Date
    November 19, 2020
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    008213219900228
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AS REPORTED: THE PATIENT ADVOCATE SUBMITTED A FORM STATING THE PATIENT DIED ON (B)(6) 2020 DUE TO INFECTION FROM VEGETATION ON PATIENTS DEVICE. THERE WERE NO SPECIFIC ALLEGATIONS MADE AGAINST THE LEADS. THERE IS NO INFORMATION ON WHAT CAUSED THE INFECTION. TO THE BEST OF OUR KNOWLEDGE THE LEADS WERE NOT INVOLVED. THIS IS SIMILAR TO EVENTS MDR 2183787-2020-00092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409136 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W5816987 008213219900228

    Patients

    Seq Age Sex Outcome Treatment
    1 Death