BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 19713198 · Received July 10, 2024

    Report

    Report Number
    3027386225-2024-00065
    Event Type
    Death
    Date Received
    July 10, 2024
    Date of Event
    March 13, 2024
    Report Date
    May 30, 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

    REPORTED IN MEDTRONIC DATABASE: PATIENT DEATH WAS REPORTED, NO ADDITIONAL DETAILS SURROUNDING CAUSE OF DEATH WAS REPORTED. DATE OF EXPLANT: (B)(6) 2023. DATE OF DEATH: (B)(6) 2023. PATIENT DEATH DUE TO UNKNOWN CAUSES; DEVICE RETURNED FOR ANALYSIS POST-AUTOPSY. TESTING OF RETURNED DEVICE DETERMINED IPG BATTERY OKAY, DEVICE WAS INTERROGATED WITH NO ANOMALIES FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359251 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death