BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 19657354 · Received July 2, 2024

    Report

    Report Number
    3027386225-2024-00062
    Event Type
    Death
    Date Received
    July 2, 2024
    Date of Event
    May 1, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT NAME (B)(6), AGE 33. CAUSE OF DEATH WAS MIXED DRUG TOXICITY.

    Description of Event or Problem · 0

    PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS. PATIENT DEATH DUE TO MIXED DRUG TOXICITY; DOD: (B)(6) 2018; EXPLANT: (B)(6) 2018. RETURNED BY (B)(6) MEDICAL EXAMINER IN (B)(6); PHONE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801799 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Death