BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 6018069 · Received October 11, 2016

    Report

    Report Number
    3004209178-2016-21560
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 17, 2016
    Report Date
    October 11, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT WENT THROUGH THE SECURITY GATE AT THE (B)(6) ON (B)(6) 2016 AND SINCE THEN THEY HAD SOME SYMPTOM RETURN. THE PATIENT WAS NAUSEOUS, WAS NOT FEELING GOOD IN GENERAL, AND FELT SICK. THIS WAS DUE TO A GRADUAL CHANGE IN THERAPY OR SYMPTOMS. THE INDICATIONS FOR USE FOR THIS PATIENT WERE GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667844 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR