BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 5768913 · Received July 5, 2016

    Report

    Report Number
    3004209178-2016-13451
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    June 9, 2016
    Report Date
    July 5, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS, INCLUDING NAUSEA AND VOMITING. IT WAS FURTHER STATED THAT THE IMPEDANCES OF THE DEVICE WERE OUT OF RANGE, GIVING VALUES OF C <(>&<)>3 15166, 2<(>&<)>3 14949, AND C<(>&<)>2 401 OHMS. THERE ARE NO INTERVENTIONS PLANNED YET. INDICATION FOR IMPLANT IS GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422776 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR