BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2874022 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11849
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 26, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V856545, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHOCKING AND JOLTING SENSATION. IT WAS NOTED THE PATIENT'S HUSBAND PUT IN AN (B)(4) A MONTH OR SO PRIOR. PATIENT GOT A SHOCK FROM IT THE DAY HE PUT IT INTO THE GROUND. PATIENT HAD A COLLAR IN HAND AND WAS TWO FEET AWAY FROM THE FLAG. PATIENT WAITED 3-4 WEEKS TO GO INTO THE DOCTOR. PATIENT REPORTED NOT FEELING STIMULATION AFTER THE SHOCK. PATIENT WAS REPROGRAMMED AND THEY WERE FEELING STIMULATION AGAIN IN THE VAGINA AND HAVING GOOD BOWEL MOVEMENTS AGAIN. ON (B)(6) 2012, THE PATIENT WENT OUT TO FRONT PORCH TO WATER PLANTS AND GOT SHOCKED AGAIN. IT WAS NOTED THERE WAS A WIRE ON THE CEILING OF THE PORCH THAT WAS ABOUT 12 INCHES AWAY FROM THE PATIENT. AFTER THIS THE PATIENT STOPPED FEELING STIMULATION UNTIL THE DAY OF REPORT. IT WAS NOTED THE PATIENT'S STIMULATION NORMALLY STARTED IN THE TOES AND THEY STARTED FEELING THAT THE DAY OF REPORT. SINCE THE SHOCK HAD OCCURRED, THE THERAPY HAD NOT BEEN HELPING. IT WAS CONFIRMED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON AND THE SETTING WAS 3.9 ON PROGRAM 3. PATIENT INCREASED SETTING TO 4.1 AND NOTED THEY RELIEVED GAS WHEN THEY INCREASED THE SETTING AND ALSO FELT STIMULATION AGAIN. FOLLOW UP FROM THE REPRESENTATIVE REPORTED THEY HAD NO NEW INFORMATION ON THE PATIENT AND THAT THEY HAD NOT SEEN THE PATIENT SINCE (B)(4) 2012. IT WAS LATER REPORTED THE PATIENT HAD SHOCKING AND JOLTING. IT WAS NOTED THE PATIENT HAD TO WALK OUT THEIR FRONT DOOR AND HAD AN OVERHEAD INVISIBLE FENCE OVER THE EAVE. IT WAS ALSO NOTED THERE WAS A PERIOD WHERE THEY WERE NOT GETTING STIMULATION. IT WAS ALSO NOTED THE PATIENT COULD NOT GET TO THEIR FRONT PORCH WITHOUT PASSING BY THE INVISIBLE FENCE FOR THEIR DOGS. THE LINE WAS LAID UP THROUGH THE TOP OF THE EAVE AND OVER THE TOP OF THE GARAGE SO THE DOGS COULD COME TO THE FRONT PORCH WITHOUT BEING SHOCKED. IT WAS NOTED THE PATIENT HAD TWO INCIDENTS OF SHOCKING. THE PORCH IS ONLY 12 FOOT ACROSS AND BECAUSE THE PATIENT DIDN'T WANT TO GET SHOCKED THEY DIDN'T GO OUT THERE. PATIENT HAD NOT GONE TO THEIR DOCTOR YET BUT HAD BEEN ADJUSTING THEIR SETTINGS AS NEEDED. PATIENT DOES NOT EVEN TOUCH THEIR DOGS BECAUSE OF THE COLLARS THAT CORRELATE WITH THE INVISIBLE FENCE. IT WAS NOTED THE PATIENT FELT BETTER REGARDING THEIR DOGS AND WAYS TO TAKE CARE OF THEIR DEVICE. IT WAS ALSO NOTED THE PATIENT WENT THROUGH A LOT TO GET HER STIMULATION AND DOESN'T WANT TO DO ANYTHING THAT WOULD JEOPARDIZE THAT, INCLUDING INVISIBLE FENCE AND EXPOSURE. 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