BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 23027704 · Received September 11, 2025

    Report

    Report Number
    3027386225-2025-00114
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    July 28, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT UNHAPPY WITH SYMPTOM RELIEF COMPARED TO FIRST SYSTEM; SYSTEM EXPLANTED AND ANALYZED REVEALING A BROKEN LEAD (WHICH WOULD LIKELY LEAD TO HIGH IMPEDANCES). NO ISSUE WITH IPG. NO FURTHER ACTION TO BE TAKEN.

    Additional Manufacturer Narrative · 0

    EXPLANTED DEVICE WAS SENT TO ENTERRA MEDICAL FOR ANALYSIS, RESULTS PENDING.

    Description of Event or Problem · 0

    HIGH IMPEDANCE - ABOVE 800. PATIENT REPORTED THAT THERAPY WAS NOT EFFECTIVE AS WITH FIRST SYSTEM. THE PATIENT REPORTED TO THE PROVIDER THAT THE SYMPTOM IMPROVEMENT WAS NOT LIKE HER FIRST SYSTEM. INTERROGATION OF THE DEVICE BY THE PROVIDER REVEALED AN IMPEDANCE ABOVE 800 OHMS. DEVICE REPLACEMENT WAS RECOMMENDED. AT THE TIME OF SURGERY, IMPEDANCES: C&2 = 3609 OHMS, C&3 = 297 OHMS, AND 2&3 = 3750 OHMS. THE SURGEON NOTED THAT LEAD 2 (NHT) WAS BROKEN INSIDE THE POCKET DURING INSPECTION, WHILE LEAD 3 WAS INTACT. A COMPLETE SYSTEM REPLACEMENT WAS PERFORMED WITH IMPEDANCES WITHIN THE SPECIFIED RANGE OF 200-800 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304385 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other