BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 22141124 · Received June 4, 2025

    Report

    Report Number
    3027386225-2025-00057
    Event Type
    Death
    Date Received
    June 4, 2025
    Date of Event
    August 17, 2021
    Report Date
    May 6, 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

    PATIENT DEATH - DEVICE EXPLANTED AS PART OF AUTOPSY. CAUSE OF DEATH WAS COMPLICATIONS OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (NOT ENTERRA DEVICE RELATED) PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS. CHECKED IN AT MDT (B)(6) 2025 MDT RECORD ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709546 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death