BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2767413 · Received October 1, 2012

    Report

    Report Number
    3004209178-2012-08743
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V800436 IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND RETURN OF SYMPTOMS. IT WAS ALLEGED THAT THE PROGRAMMER KEEPS SHUTTING OFF AND THAT IT IS TURNING THE STIMULATION OFF. STIMULATION WAS ON WHEN THE PATIENT LEFT THEIR HOUSE, BUT UPON RETURNING HOME, THE PATIENT FELT SYMPTOMS AND HAD FREQUENT VOIDS. STIMULATION WAS CONFIRMED TO BE OFF AND THE PATIENT FELT NO STIMULATION SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT KNOWN TO BE RELATED TO THE COMPLAINT. THE SYMPTOMS RETURNED IN THE PATIENT'S PERINEUM AND THE PATIENT'S STATUS WAS "FAIR." PATIENT WAS FRUSTRATED WITH THE DEVICE AND EXPERIENCED THESE PROBLEMS ALONG WITH MORE FREQUENT BATHROOM VISITS EVERY DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR