BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19730463 · Received July 12, 2024

    Report

    Report Number
    3027386225-2024-00070
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    December 14, 2023
    Report Date
    June 24, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    OUT OF RANGE IMPEDANCE WITH SET SCREW ISSUE. LEADS DISCONNECTED, WIPED DOWN AND RECONNECTED. IMPEDANCE BACK IN RANGE. IT WAS FOUND WHEN SHE WENT IN FOR AN ADJUSTMENT. THEY SCHEDULED A SURGERY TO OPEN UP THE POCKET WIPE DOWN THE LEADS AND REATTACHED. IMPEDANCE WAS THEN IN RANGE. PATIENT IS DOING WELL AFTER REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301067 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other