BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5486812 · Received March 8, 2016

    Report

    Report Number
    3004209178-2016-04135
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Date of Event
    February 11, 2016
    Report Date
    February 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28, LOT# VA0XDA1, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEURO STIMULATOR FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT ON ALL PROGRAMS WHEN THE PATIENT TURNED IT UP TO THE POINT WHEN HE FIRST FELT THE STIMULATION, IT WOULD MIGRATE THROUGH THE SCROTUM, UP TO THE HEAD OF HIS PENIS AND CLAIMED THAT IT FELT LIKE IT WAS BURNING. THIS FEELING WAS "PRETTY MUCH CONSTANT." WHEN HE WOULD SET IT VERY LOW, IT WAS OKAY BUT WHEN HE BENT FORWARD HE COULD FEEL IT MIGRATE INTO THIS LEFT TESTICLE. HE DESCRIBED IT AS UNCOMFORTABLE. SOMETIMES IT FELT LIKE HE WAS GETTING "ZAPPED" OR AN "ELECTRIC SHOCK." NORMAL EVERYDAY ACTIVITY LED TO THE EVENT. NO DIAGNOSTICS OR TROUBLESHOOTING HAD BEEN PERFORMED YET. THERE WAS A PLAN FOR THE REP TO SEE THE PATIENT AND TWEAK THE SETTINGS, AND POSSIBLY NARROWING THE PULSE WIDTH. NO ACTIONS OR INTERVENTIONS HAD BEEN TAKEN YET. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. NO SURGICAL INTERVENTION OCCURRED AND NONE WAS PLANNED. THE PATIENT WAS ADVISED TO TURN THE STIMULATION TO SUB SENSORY LEVELS UNTIL THE REP COULD SEE THE PATIENT. THE REP LATER REPORTED THAT THE REP AND A NURSE MET WITH THE PATIENT AT THE DOCTOR'S CLINIC ON (B)(6) 2016. THE NURSE USED THE CLINICIAN PROGRAMMER (CP) TO ADJUST THE SETTINGS. ON ALL 4 PROGRAMS, THE PULSE WIDTH WAS NARROWED TO ITS LOWEST POINT AND THE RATE WAS ADJUSTED DOWN TO 10 HZ. ON PROGRAM 1, THEY FOUND IT HELPFUL TO ALSO ACTIVATE 2 NEGATIVE ELECTRODES (0-, 1-, 3+). THEY HAD THE PATIENT MOVE AROUND WHILE ON EACH PROGRAM TO MAKE SURE THAT THE UNCOMFORTABLE STIMULATION WAS GONE. THE PATIENT LEFT HAPPY WITH THE NEW SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143688 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR