BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD

    MDR report key: 19134052 · Received April 18, 2024

    Report

    Report Number
    2183787-2024-00027
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    March 14, 2024
    Report Date
    September 6, 2024
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    00821329900211
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. 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; THEREFOR, 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

    PATIENT WAS BROUGHT TO HOSPITAL FOR LEAD EXTRACTION BECAUSE OF INFECTION. LEAD REMAINS IMPLANTED. THIS EVENT IS RELATED TO 2183787-2024-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288225 MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511211 W2580628 00821329900211

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention