BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM

    MDR report key: 9451025 · Received December 11, 2019

    Report

    Report Number
    2183787-2019-00106
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    September 23, 2019
    Report Date
    November 13, 2019
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    00821329900228
    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

    THE GREATBATCH MEDICAL 4047 LEAD WAS IMPLANTED ON (B)(6) 2019 AND POST THE PROCEDURE PERICARDITIS AND EFFUSION WAS IDENTIFIED. THE PATIENT WAS TREATED AND IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248705 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W4745953 00821329900228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention