BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTESTINAL STIMULATOR

    MDR report key: 23726580 · Received December 4, 2025

    Report

    Report Number
    MW5179938
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REASON FOR CALL WAS TO INQUIRE IF PATIENT'S INS WAS "WORKING APPROPRIATELY." NO FURTHER DETAILS PROVIDED. AGENT ASKED FOR PATIENT INFO AND DISCOVERED PATIENT HAD ENTERRA DEVICE. CALLER WAS TRANSFERRED TO ENTERRA. 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
    2438708 INTESTINAL STIMULATOR INTESTINAL STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown