BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3181917 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10700
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 31, 2013
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V802404, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE TRYING TO ADJUST STIM AND A PAIN/ BURNING IN VAGINA AREA STARTED 3-4 DAYS AGO. THE PATIENT DIDN'T FEEL THE STIM SHE AND WAS CURRENTLY AT HER HCP (HEALTH CARE PROVIDERS) OFFICE. THE DOCTOR WAS NOT AVAILABLE. IT WAS ALSO REPORTED THAT THE PATIENT FALLS ALL THE TIME, THE LAST TIME WAS A WEEK AGO. IT WAS LATER REPORTED ON(B)(6) 2013 THAT THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. IT WAS VERY PAINFUL AND THERE WAS A BURNING SENSATION. THE PATIENT FELT SHE NEEDED REPROGRAMMING DONE. WHEN THE PATIENT TRIES TO PROGRAM IT, IT FEELS TOO HIGH. THE PATIENT HAD NOT HAD A RETURN OF SYMPTOMS. THE DEVICE WAS IMPLANTED TO HELP HER CONTROL HER BLADDER. THE PATIENT WOULD WET HERSELF BEFORE SHE COULD MAKE IT TO THE BATHROOM. ON (B)(6) 2013 A WOMAN IN THE HEALTHCARE PROVIDER'S OFFICE HELPED HER TURN HER STIM OFF. THE PATIENT HAD MULTIPLE FALLS; SHE FELL ABOUT 2-3 WEEKS AGO. THE PATIENT NEVER HAD THE DEVICE CHECKED AFTER THAT BECAUSE THERE WASN'T ANY HCP'S THERE THAT COULD HELP HER. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE PROGRAMMER BATTERY WAS SHOWING LOW ICON. THE PATIENT CHANGED TO NEW BATTERIES AND WAS NOW SEEING REGULAR PROGRAMMING SCREEN. THE PATIENT WAS AT 5.9V ON PROGRAM 1 AND STIM WAS OFF. STIM WAS TURNED TO 0.0V AND THEN STIM WAS TURNED ON. AT 2.2V THE PATIENT FELT STIM IN HER VAGINA AND IT WAS COMFORTABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY, BUT WERE WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE. IT WAS NOTED THE PATIENT USED THE RESTROOM 5-6 TIMES A NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283431 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR