BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19801426 · Received July 22, 2024

    Report

    Report Number
    3027386225-2024-00087
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 17, 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

    DEAD BATTERY. DATE OF IMPLANT (B)(6) 2020. GEN CHANGE WAS TODAY. DR (B)(6) SAID THE FAMILY WAS HAPPY WITH THERAPY. SETTINGS ARE HIGH AND RECOMMENDED LOWERING. DR (B)(6) WANTED THE SAME SETTINGS. THE GENERATOR WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004894 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Other