BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 22371562 · Received July 1, 2025

    Report

    Report Number
    3027386225-2025-00084
    Event Type
    Death
    Date Received
    July 1, 2025
    Date of Event
    May 12, 2025
    Report Date
    June 11, 2025
    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

    PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. RECEIVED FROM (B)(6). CODED AS C-500 NON-COMPLAINT AT MEDTRONIC AND CLOSED. ORIGINALLY IMPLANTED ON (B)(6) 2022

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418591 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death