BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA II IPG

    MDR report key: 19757013 · Received July 16, 2024

    Report

    Report Number
    3027386225-2024-00080
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 11, 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

    YESTERDAY I SPOKE ON THE PHONE WITH A PATIENT FROM FACEBOOK, AND SHE REPORTED THAT SHE HAS HAD TO HAVE MULTIPLE SURGERIES TO MOVE THE DEVICE AROUND DUE TO INCORRECT PLACEMENT THAT LED TO PAIN. ALSO, SHE SAID THAT THOUGH THEY RESOLVED THE PLACEMENT ISSUE AFTER ANOTHER SURGERY, HER DEVICE IS NOW MALFUNCTIONING VIA "SPASMS" (THAT IS THE WORD SHE USED). WE SPOKE ON THE PHONE BECAUSE ALTHOUGH SHE SHARED THIS SERIOUS COMPLAINT INFORMATION, HER EXPERIENCE WITH ENTERRA HAS BEEN LIFE CHANGING, AND AFFECTED HER LIFE SO POSITIVELY THAT SHE WILL QUOTE "NEVER EVEN THINK OF GETTING IT REMOVED - IT HAS PROVIDED TOO MUCH RELIEF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715195 ENTERRA II IPG ENTERRA II IPG LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other