BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II NEUROSTIMULATOR

    MDR report key: 23905308 · Received December 29, 2025

    Report

    Report Number
    MW5181205
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: INFORMATION WAS RECEIVED FROM A PATIENT REGARDING A NON-(B)(6) ENTERRA STIMULATOR. THE REASON FOR CALL WAS THE PATIENT REPORTED THAT THE THERAPY HADN'T WORKED FOR QUITE A WHILE. THE PATIENT STATED THAT THEIR SURGEON HAD MOVED AWAY AND THEY WERE LEFT WITH "THIS IMPLANT IN MY BODY". THE PATIENT CONTINUED "SO NOW I'VE HAD A FEEDING TUBE" AND THEY CURRENTLY WERE IN THE HOSPITAL AND THEY NEEDED TO GET SOMEONE OUT TO "INVESTIGATE THIS DEVICE." 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
    2459627 ENTERRA II NEUROSTIMULATOR INTESTINAL STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown