BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35CM

    MDR report key: 12373719 · Received August 26, 2021

    Report

    Report Number
    2183787-2021-00073
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    March 18, 2021
    Report Date
    August 3, 2021
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    00802526058066
    PMA / PMN Number
    P130012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AS REPORTED: THE PATIENT HAD EPICARDIAL LEAD WITH HIGH THRESHOLDS, PACER DEPENDENCE AND LOW IMPEDANCES 250-350 (CONSIDERED NORMAL FOR EPICARDIAL LEADS ) WHICH WAS CAUSING CONSIDERABLE CURRENT DRAIN AND MULTIPLE GEN CHANGES SO THE PHYSICIAN OPTED FOR MICRA AV. THE EPICARDIAL LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269746 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511211 W1321526 00802526058066

    Patients

    Seq Age Sex Outcome Treatment
    1