BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 921634 · Received September 21, 2007

    Report

    Report Number
    3004209178-2007-03069
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Report Date
    January 5, 2005
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION NUMBER WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF EVENTS REPORTED BY CONSUMERS BETWEEN 2005 AND 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 15 UNREPORTED MALFUNCTION EVENTS FOR MODEL 3023 AND 2 UNREPORTED MALFUNCTION EVENTS FOR MODEL 3116 FOR THE ABOVE TIME PERIOD (PRODUCT CODE EZW).

    Description of Event or Problem · 1

    THE PATIENT REPORTED SATISFACTORY SYMPTOM RELIEF, EVEN WHILE USING A WHEELCHAIR. THE PATIENT STATED THE DEVICE TURNS OFF WHEN SHE GOES THROUGH STORE SECURITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MPROC, JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other