BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 20835284 · Received December 3, 2024

    Report

    Report Number
    3027386225-2024-00145
    Event Type
    Death
    Date Received
    December 3, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 7, 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

    PATIENT DEATH UNRELATED TO DEVICE; ANALYSIS OF DEVICE SHOWED NO FAILURES. NO FURTHER ACTION TO BE TAKEN. PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. PRODUCT INFORMATION REPORT: REASON FOR RETURN - DEATH; COMPLETED BY (B)(6); PHONE (B)(6), IR REPORT: IMPLANT DATE (B)(6) 2023, BATTERY OK. LEADS RECEIVED CONNECTED TO DEVICE AND SEGMENTED AT PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378003 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Death