BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2605443 · Received June 8, 2012

    Report

    Report Number
    3004209178-2012-04270
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Report Date
    May 15, 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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), LEAD: MODEL 3889-28, LOT# V933654, IMPLANTED: (B)(6) 2012, EXPLANTED: NA; PROGRAMMER: MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT EXPERIENCED NO STIMULATION SENSATION AND WAS URINATING MORE FREQUENTLY. THE PATIENT NOTICED THE TINGLING STOPPED AND SYMPTOMS STARTED TO RETURN FOR THE LAST SEVERAL DAYS. THE PATIENT HAD BEEN MOVING AND DOING VARIOUS ACTIVITIES THAT MAY HAVE CONTRIBUTED TO THIS. THE PATIENT WAS ON PROGRAM 2 AND INCREASED IT UP TO 6.0V BUT DID NOT FEEL ANYTHING. IT WAS CONFIRMED THAT STIMULATION WAS TURNED ON. THE PATIENT CHANGED TO PROGRAM 3 AT 1.1V AND COULD FEEL STIMULATION ON HER LEFT SIDE IN BIKE SEAT AREA. ON PROGRAM 4 SHE FELT STIMULATION ON HER LEFT SIDE AND STATED THAT SHE DIDN'T LIKE THE PULSING SENSATION. PROGRAM 1 WAS ALSO MORE TO HER LEFT SIDE. THE PATIENT'S HCP HAD DETERMINED THAT WHEN STIMULATION WAS FELT ON THE RIGHT SIDE, IT WORKED BETTER. THE PATIENT PLANNED TO TRY PROGRAM 3. IT WAS LATER REPORTED THAT THE PATIENT'S STIMULATION TURNED OFF. THE PATIENT PROGRAMMER CONFIRMED THAT THE DEVICE WAS OFF. THE PATIENT TURNED STIMULATION BACK ON, AND STATED THAT PROGRAM 2 WAS NOT WORKING. THE PATIENT PLANNED TO CALL HER HCP IF NONE OF THE PROGRAMS GAVE HER RELIEF. 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