BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19217375 · Received April 30, 2024

    Report

    Report Number
    3027386225-2024-00035
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    November 30, 2023
    Report Date
    April 4, 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 Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS. INFORMATION TAKEN FROM MEDTRONIC PRODUCT RETURN DATA SPREADSHEET. PRODUCTS WERE RETURNED TO MEDTRONIC AND ANALYZED - IPG PASSED FUNCTIONAL TESTING; LEADS WERE RETURNED IN SEGMENTS DUE TO THE EXPLANT PROCEDURE BUT ANALYSIS DETERMINED THAT CONTINUITY WAS COMPLETE AND THERE WERE NO ELECTRICAL SHORTS BETWEEN THE CIRCUITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176289 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other