BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 20097847 · Received August 29, 2024

    Report

    Report Number
    3027386225-2024-00098
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 30, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT HAS HAD IPG ADJUSTED TO COMPENSATE FOR HIGH IMPEDANCE; NO FURTHER ACTION TO BE TAKEN. (B)(6) CALLED TO REPORT THAT PATIENT HAS HIGH IMPEDANCE WITH ELECTRODE 3. IT IS OVER 20,000. THE PATIENT IS DOING WELL ON 2-C STIMULATION. THE PATIENT WILL BE MONITORED AND NO FURTHER ACTION IS PLANNED UNLESS SYMPTOMS RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802034 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown Other| R