BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 20260294 · Received September 19, 2024

    Report

    Report Number
    3027386225-2024-00108
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 22, 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 PRESENTED TO THE SURGEON OFFICE COMPLAINING OF DEEP ABDOMINAL PAIN THAT RADIATED TO THE BACK BEING SEVERE DESCRIBED AS SHARP AND THROBBING, PATIENT STATED THAT THE PAIN WAS WORSE AFTER MEALS AND WITH THE NEUROSTIMULATOR ON HIGHER SETTINGS. SURGERY WAS SCHEDULED FOR A REVISION OF THE SYSTEM. DUE TO THE PAIN, THE SETTINGS OF THE GASTRIC STIMULATOR WERE DECREASED, WORSENING THE PATIENT'S SYMPTOMS. PRIOR TO IT THE PATIENT WAS DOING WELL, WITH IMPROVEMENT IN NAUSEA AND VOMITING AND HAD GAIN WEIGHT. PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2024 FOR ROBOTIC IMPLANTATION OF J-TUBE AND REVISION OF LEADS. AN EGD WAS PERFORMED, THERE WERE NO EXPOSE WIRES NOTED, SURGEON REVISED LEADS THAT APPEAR INTACT, AS PRECAUTIONARY HE DID AN OMENTUM PATCH COVERING THE LEADS. FOLLOW-UP WITH PATIENT: SHE IS DOING WELL. THERE HAS BEEN NO MORE PAIN, AND THE SETTINGS ARE BACK TO BEFORE THE PAIN/THROBBING STARTED. HER SYMPTOMS ARE BETTER. SHE IS ONLY DOING TUBE FEEDS AT NIGHT AND HAS BEEN ABLE TO EAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746658 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Other