BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 19943097 · Received August 8, 2024

    Report

    Report Number
    3027386225-2024-00083
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 11, 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

    FEMALE PATIENT WITH SEVERELY UNDER CONTROLLED DIABETES AND OVERWEIGHT. A1C OF 17. PHYSICIAN STATED DEVICE WAS WORKING FOR PATIENT BUT SHE WANTED IT OUT. ALSO MENTIONED SHE STRUGGLES WITH MENTAL ILLNESS. DEVICE REMOVED YESTERDAY AND PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2402111 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other