BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA NEUROSTIMULATOR

    MDR report key: 23671174 · Received November 28, 2025

    Report

    Report Number
    MW5179449
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT SUBMITTED ONLINE: "I HAVE AN ENTERRA NEUROSTIMULATOR THAT WAS IMPLANTED IN (B)(6) OF 2023. IT WAS A REPLACEMENT FROM MY FIRST IMPLANT IN 2016. I BEGAN FEELING MORE AND MORE NAUSEOUS IN (B)(6), THAT TURNED INTO MULTIPLE TIMES A WEEK VOMITING AND HAVE FELT WHAT MIMICS A CHARLEY HORSE AT THE SIGHT OF IT. I'VE HAD AN XRAY THAT SHOWED THE LEADS WERE INTACT AND MY DOCTOR'S OFFICE THINKS IT SHOULD BE INTERROGATED FOR BATTERY, THE DEVICE ITSELF OR IF IT NEEDS ADJUSTING. THE SURGEON IS IN (B)(6) BUT I AM IN (B)(6). THEY RECOMMENDED CHECKING WITH YOU TO SEE IF THERE IS ANY PROVIDER NEARBY THAT COULD DO THIS BEFORE I MAKE THE TRIP OUT THERE. CAN YOU HELP ME FIND SOMEONE CLOSER BY?" PATIENT WAS DIRECTED TO (B)(6). IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149832 ENTERRA NEUROSTIMULATOR INTESTINAL STIMULATOR LNQ ENTERRA MEDICAL, INC. UNKNOWN IMPLANTABLE NEUROSTIMULATOR (INS)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown