BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3040598 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04850
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V933650, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SURGING/SHOCKING/JOLTING SENSATION. IT WAS ADDED THE PATIENT WAS GETTING INTERMITTENT SHOCKING FROM HER STIMULATION SYSTEM. IT WAS NOTED THE PATIENT FELT SURGING AND SHOCKING IN THE AREA OF PARESTHESIA, IN HER BACK, AND ALL THE WAY DOWN HER LEGS. IT WAS ADDED THE PATIENT SOMETIMES FELT IT OVER HER WHOLE BODY ALSO. IT WAS STATED THE PATIENT HAS REFLEX SYMPATHETIC DYSTROPHY. IT WAS NOTED THE EVENTS WERE RANDOM IN NATURE AND COULD OCCUR WITH CERTAIN MOVEMENTS BUT THE PATIENT WAS UNABLE TO REPRODUCE THEM. THIS HAD BEEN HAPPENING FOR ABOUT 2 TO 3 MONTHS. IT WAS STATED THERE WAS NO PAIN AT THE POCKET SITE AND THE STIMULATION WAS "STILL THE SAME AND IN THE RIGHT AREAS". IT WAS NOTED THE SURGING/SHOCKING STARTED AFTER ANOTHER CONCURRENT STIMULATION SYSTEM WAS PLACED. IT WAS ADDED THAT THIS OCCURRED OFTEN THROUGHOUT THE DAY. IT WAS STATED THE PATIENT HAD "GOOD" COVERAGE RIGHT NOW SO PROGRAMMING WAS NOT NEEDED. IT WAS NOTED THAT IMPEDANCES WERE IN A NORMAL RANGE, 600-900 OHMS. THERE WERE NO LEAD MIGRATION CONCERNS. IT WAS LATER REPORTED THE PATIENT'S STIMULATION SYSTEM IS CURRENTLY NOT RUNNING. IT WAS STATED THE PATIENT BELIEVED THAT THE SHOCKING/JOLTING WAS COMING FROM "THOSE WIRES". IT WAS NOTED THE CONCURRENT DEVICE WAS PLACED AT LEAST 20 CM AWAY FROM THEIR STIMULATION SYSTEM. IT WAS ADDED THAT THE DOCTOR DID NOT WANT TO DO ANY SURGICAL INTERVENTIONS AT THE TIME OF THIS REPORT. IT WAS STATED THE PATIENT WOULD CONTACT AN UROLOGIST TO EVALUATE THE DEVICE TO DETERMINE WHAT THE NEXT STEP WOULD BE. IT WAS NOTED THE PATIENT'S DOCTOR FELT THAT THE PATIENT MAY HAVE SOME UNDERLYING PSYCHOLOGICAL ISSUES WHICH MAY BE PLAYING A ROLE IN HER PERCEPTION OF THE JOLTING FEELING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143485 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1