BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 19756703 · Received July 16, 2024

    Report

    Report Number
    3027386225-2024-00078
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 10, 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 SAYS SHE IS HAVING CONSTANT DISCOMFORT AROUND HER POCKET SITE SINCE RECEIVING HER ENTERRA IMPLANT IN THE FALL OF 2023 BY DR (B)(6). SAYS SHE CAN FEEL HER STIMULATOR "FLIPPING" AROUND IN THE POCKET. IS CONSULTING HER SURGEON TO SEE IF SHE IS IN NEED OF A REVISION. SHE ALSO LISTED SEVERAL OTHER HEALTH ISSUES THAT COULD BE CONTRIBUTING TO HER ABDOMINAL DISCOMFORT, AND UPCOMING PROCEDURES TO ADDRESS THOSE ISSUES. SHE AND DR (B)(6) ARE PLANNING TO DISCUSS WAITING ON A REVISION UNTIL THOSE OTHER PROCEDURES ARE DONE, TO SEE IF THEY HAVE AN IMPACT ON THE DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505380 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other