BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20033376 · Received August 22, 2024

    Report

    Report Number
    3027386225-2024-00090
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD WORSENED GASTROPARESIS SYMPTOMS. THE PATIENT HAD A PROCEDURE DONE AFTER HER INITIAL IMPLANT, AND THE LEAD (B)(6) WAS ACCIDENTALLY CUT. THE SYSTEM WAS COMPLETELY REPLACED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953338 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other