BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 19954104 · Received August 9, 2024

    Report

    Report Number
    3027386225-2024-00085
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    June 27, 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

    PATIENT HAD DISCOMFORT WITH CURRENT BATTERY LOCATION. DR (B)(6) TOOK HER BACK TO SURGERY ON 6/28 AND REPOSITIONED THE BATTERY TO A NEW LOCATION. DEVICE POSITION REVISED; NO PRODUCT TO ANALYZE. INVESTIGATION TO BE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493507 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other