BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTREL II (X2)

    MDR report key: 1034846 · Received April 28, 2008

    Report

    Report Number
    2182207-2008-02249
    Event Type
    Malfunction
    Date Received
    April 28, 2008
    Report Date
    May 22, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE REFERENCE: FAMILONI BO, ET AL. "GASTRIC ELECTRICAL STIMULATION HAS AN IMMEDIATE ANTIEMETIC EFFECT IN PATIENTS WITH GASTROPARESIS". IEEE TRANS BIOMED ENG JUNE 2006: 53(6): 1038-1046. THIS STUDY MONITORED ELEVEN PATIENTS WITH REFRACTORY GASTROPARESIS TO EXAMINE THE CLINICAL FEASIBILITY AND EFFICACY OF GASTRIC ELECTRICAL STIMULATION (GES). THREE PATIENTS PRESENTED WITH INCREASED GASTROINTESTINAL SYMPTOMS AFTER THEIR DEVICE SPONTANEOUSLY SWITCHED OFF. IN THE CLINIC, THE STIMULATOR WAS INTERROGATED WITH A CONSOLE PROGRAMMER TO DETERMINE ITS SETTING. IT WAS SUSPECTED THE SPONTANEOUS SWITCH OFFS OCCURRED AFTER EXPOSURE TO LARGE ELECTROMAGNETIC FIELDS OF UNKNOWN ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTREL II (X2) LGW MEDTRONIC NEUROMODULATION 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD (X4) MODEL 4300| EXPLANTED| PROGRAMMER MODEL 7432