BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 20359546 · Received October 3, 2024

    Report

    Report Number
    3027386225-2024-00113
    Event Type
    Death
    Date Received
    October 3, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 10, 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

    PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. CATEGORIZED BY MDT AS PATIENT DEATH DUE TO MYOCARDIAL INFARCTION (C500/NON-COMPLAINT) AND CLOSED. IMPLANT DATE (FOR IPG) OF (B)(6) 2021 PATIENT DEATH. NO CAUSE WAS MENTIONED IN MDT DATABASE; INFORMATION REPORT LISTED MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878547 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death