BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA II IPG

    MDR report key: 19711584 · Received July 10, 2024

    Report

    Report Number
    3027386225-2024-00068
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    March 19, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT HER SIMULATOR IS CURRENTLY TURNED OFF AND IS AWAITING REMOVAL BECAUSE A PIECE OF IT ALLEGEDLY CORRODED (COULDN'T SPECIFY WHAT PIECE, BUT SOUNDED AS IF IT WAS INTERNALLY). SAYS SYMPTOMS HAVE PROGRESSED. FOLLOW-UP WITH PROVIDER AND PATIENT: PATIENT WAS EXPLANTED DUE TO INEFFECTIVE TREATMENT OF SYMPTOMS. NO CORROSION WAS FOUND IN EXPLANTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363944 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other