BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 19522509 · Received June 12, 2024

    Report

    Report Number
    3027386225-2024-00061
    Event Type
    Death
    Date Received
    June 12, 2024
    Date of Event
    April 19, 2024
    Report Date
    September 29, 2025
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT NAME (B)(6). AGE 70 DOD (B)(6) 2022 UNKNOWN CAUSE OF DEATH, NO REASON TO SUSPECT DEVICE INVOLVEMENT.

    Description of Event or Problem · 0

    PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS. DEVICE APPEARS TO HAVE BEEN SENT FROM THE (B)(6) EMBALMING CENTER ON (B)(6) 2024. ORIGINAL IMPLANT DATE OF (B)(6) 2021. LAST SESSION OF PATIENT USE: (B)(6) 2021. DEVICE REMOVED PRIOR TO CREMATION. NO INDICATION DEATH CAUSED BY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189930 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Death