BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54CM

    MDR report key: 18331977 · Received December 14, 2023

    Report

    Report Number
    2183787-2023-00079
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    November 14, 2023
    Report Date
    August 7, 2024
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    00802526497704
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI UPDATED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. D4: UDI UPDATED. H2 : CORRECTION MARKED. DIFFERENT UDIS WERE USED WHEN SKU 200988-009, SN (B)(6) WAS MANUFACTURED. WHEN GREATBATCH (GBM) TRANSITIONED TO GS1-128 BARCODES, THE GTIN FOR SKU 200988-009 WAS ASSIGNED. THE GTIN IN THE GUDID DATABASE WILL NOT ALIGN WITH THE BARCODE FROM (B)(6) 2010 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 (B)(6) 2013; THEREFORE, THE UDI FIELD (D4) IN FORM 3500A WILL NOT ALIGN WITH THE GUDID ENTRY DUE TO THE DATE IT WAS MANUFACTURED BEING PRIOR TO GUDID IMPLEMENTATION.

    Description of Event or Problem · 0

    THE DEVICE WAS INFECTED AND THE LEAD WAS CAPPED. THIS EVENT IS RELATED TO 2183787-2023-00078.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929038 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W2493649 00802526497704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention