BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD

    MDR report key: 18979732 · Received March 26, 2024

    Report

    Report Number
    2183787-2024-00022
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Report Date
    September 6, 2024
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    00802526497704
    PMA / PMN Number
    P130012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. H2: CORRECTION MARKED. D1: BRAND NAME UPDATED TO MATCH GUDID DATABASE ENTRY. D4: DIFFERENT UDIS WERE USED WHEN SKU 200988-XXX WAS MANUFACTURED. WHEN GREATBATCH (GBM) TRANSITIONED TO GS1-128 BARCODES, THE GTIN FOR SKU 200988-XXX WAS ASSIGNED. 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; THEREFORE, THE UDI FIELD (D4) IN FORM 3500A WILL NOT ALIGN WITH THE GUDID ENTRY DUE TO THE DATE IT WAS MANUFACTURED.

    Description of Event or Problem · 0

    LOW IMPEDANCE ON LV LEAD OCCURRED, LV LEAD MEASURMENTS OF NOISE AND <200. THE LV WAS CAPPED AND REPLACED WITH THE SECONDARY PREVIOUSLY IMPLANTED LV LEAD ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4566 MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W2640429 00802526497704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention