BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD

    MDR report key: 20713508 · Received November 18, 2024

    Report

    Report Number
    2183787-2024-00087
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 12, 2024
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDIS WERE NOT USED WHEN SKU 200988-008 WAS MANUFACTURED. THE GTIN IN THE GUDID DATABASE WILL NOT ALIGN WITH THE BARCODE AS NEW GTINS WERE ASSIGNED WHEN GBM TRANSITIONED TO THE GUDID SYSTEM. CLASS III DEVICES WERE REQUIRED TO REGISTER GTINS IN THE GUDID DATABASE ON 01-JUN-2013; THEREFOR, THE UDI FIELD (D4) IN FORM 3500A SHALL BE LEFT BANK AND WILL NOT ALIGN WITH THE GUDID ENTRY DUE TO THE DATE IT WAS MANUFACTURED.

    Description of Event or Problem · 0

    THE LEAD WAS SURGICALLY ABANDONED DUE TO HIGH THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118267 MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511211 M27097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention