BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19810849 · Received July 23, 2024

    Report

    Report Number
    3027386225-2024-00088
    Event Type
    Malfunction
    Date Received
    July 23, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DEAD BATTERY. DATE OF IMPLANT (B)(6) 2023. GEN CHANGE ON (B)(6) 2024. DR (B)(6) KNOWS THE SETTINGS ARE EXTREMELY HIGH CAUSING THE BATTERY TO DRAIN QUICKLY. MOM KNOWS THEY ARE HIGH AND WANTS THEM LEFT HIGH. CONSULTED DR (B)(6) THAT WE COULD GET LONGER BATTERY LIFE IF WE LOWERED THE RATE AND PULSE WIDTH AS BOTH ARE HIGH. THE MOTILITY GI RAISED THE SETTING WHEN HE WAS AT UF AND BECAUSE IT WORKS SO WELL, EVERYONE WANTS TO KEEP THE SETTING AS IS EVEN THOUGH THE BATTERY LIFE WILL BE SHORT. GENERATOR WAS COLLECTED TO BE SENT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936341 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Unknown Other