BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2842938 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10682
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# VA01JDV, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF STIMULATION SENSATION FOLLOWING A REPLACEMENT THE DAY PRIOR TO THIS REPORT. IT WAS NOTED THAT THERE WAS A RETURN OF INCONTINENCE. THE PATIENT REPORTEDLY WAS HAVING A DIFFICULT TIME SUSTAINING TELEMETRY FOR USING THE PROGRAMMER; IT WAS STATED THAT THE PATIENT HAD "DIFFICULTY GETTING AND KEEPING THE PROGRAMMER AND ANTENNA INTO THE CORRECT POSITION." IT WAS NOTED THAT THE PATIENT WAS ABLE TO USE IT "LAST NIGHT" AND STATED SHE COULD FEEL THE STIMULATION WITH AN AMPLITUDE OVER 6 VOLTS. IT WAS STATED THAT THE PATIENT WAS ABLE TO GET TELEMETRY AND SET THE STIMULATION TO 4.7 VOLTS, BUT THEN LOST TELEMETRY AGAIN. IT WAS INDICATED THAT THE BANDAGES FROM SURGERY AND "POSSIBLE SWELLING/FLUID" FROM REPLACEMENT MIGHT INHIBITED TELEMETRY. THIRTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD "NO SYMPTOM CONTROL AT ALL" AND "SOAKED THROUGH ALL THE DIAPERS THE PATIENT HAD TO WEAR." IT WAS STATED THAT THE AMPLITUDE WAS INCREASED TO THE HIGHEST SETTING, BUT THE PATIENT DID NOT FEEL "ANYTHING" AND THERE WAS NO IMPROVEMENT IN SYMPTOM CONTROL. THE PATIENT REPORTEDLY FELT A "POKING SENSATION IN THE FRONT" WHICH STARTED "3-4 DAYS AGO." IT WAS NOTED THAT THIS SENSATION WAS STILL FELT AFTER THE STIMULATION WAS TURNED OFF. THERE WERE NO FALLS OR TRAUMA. IT WAS NOTED THAT THE PATIENT USED A WALKER FOR KNEE REPLACEMENTS AND HAD "OTHER MEDICAL ISSUES." THE PATIENT WAS SCHEDULED TO SEE HER DOCTOR THE FOLLOWING DAY. FOUR DAYS AFTER THE LAST REPORT, IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS KEPT THEM FROM GOING TO SEE THE DOCTOR AND HAD TO "REPEATEDLY" CANCEL APPOINTMENTS AND RESCHEDULE. IT WAS NOTED THAT THE PATIENT DID NOT KNOW HOW TO USE THE DEVICE, AND STATED IT HAD "BEEN A BAD EXPERIENCE." THREE DAYS LATER, IT WAS REPORTED THAT THE PATIENT MISSED "SEVERAL" APPOINTS DUE TO HER SYMPTOMS WHICH WERE "NOT DUE TO THE DEVICE BUT OTHER CONDITIONS SUCH AS LYMPHEDEMA." IT WAS NOTED THAT THE PATIENT SLEPT "A LOT" AND HAD NOT SEEN DOCTOR SINCE IMPLANT. IT WAS LATER REPORTED THAT THE PATIENT "NEVER" HAD THERAPEUTIC EFFECT. IT WAS STATED THAT THE ADDITIONAL PROGRAMS WERE INSTALLED AS THE PATIENT "ONLY HAD ONE." THE STIMULATION REPORTEDLY WAS INCREASED MULTIPLE TIMES AND NO IMPROVEMENT WAS NOTICED IN URGENCY/FREQUENCY. IT WAS STATED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION AND FELT A "POKING SENSATION IN HER BUTT" SINCE "3-4 DAYS AGO." THE PATIENT REPORTEDLY EXPERIENCED VERTIGO AND HAD FALLEN "MANY TIMES." IT WAS STATED THAT DUE TO THE VERTIGO EPISODES, THE PATIENT WAS "UNABLE TO PHYSICALLY MAKE IT TO THE BATHROOM IN TIME SO JUST VOIDED IN DIAPER." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    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