BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 8832965 · Received July 26, 2019

    Report

    Report Number
    3004209178-2019-14387
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    February 1, 2019
    Report Date
    July 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    UDI-DI
    00643169614246
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR ISSUES. IT WAS REPORTED THAT THE PATIENT¿S DEVICE HAD BEEN SHOCKING THEM AND THE SENSATION WAS LIKE GOING INTO LABOR. IT WAS NOTED THAT THE DEVICE HAD BEEN OFF FOR A WHILE NOW AND THE PATIENT ENDED UP GETTING SICK AND HAD A GJ TUBE PLACED IN THEIR ABDOMEN; IT WAS NOTED THE PATIENT WAS TOO WEAK TO HAVE SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625946 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800 00643169614246

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR