BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4034951 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-15855
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    July 31, 2014
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V973529, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAID THAT IT WAS NOW WORKING AND THAT SHE FEELS STIMULATION REAL GOOD. THE PATIENT HAD BEEN HAVING ISSUES WITH PROGRAMMER, KEEPS ON TURNING OFF. CURRENTLY PATIENT HAS REGULAR (B)(6) BATTERIES, SUGGESTED REPLACING WITH ALKALINE. THE PATIENT TYPICALLY USES (B)(6) . THE PATIENT SAID CURRENT SETTING SHOWS 3.6 VOLTS. THE PATIENT THOUGHT THOSE BUTTONS TURNED HER HANDHELD DEVICE ON/OFF. THE PATIENT WAS UNKNOWINGLY TURNING HER DEVICE OFF. THE PATIENT WAS TO MONITOR HER SYMPTOMS NOW THAT SHE UNDERSTANDS USE OF THESE BUTTONS AND WILL LEAVE STIMULATION ON. THE PATIENT SAID THAT THE OTHER DAY HER PROGRAMMER WAS IN A LOCKED CAR AND IT WAS 120 DEGREES OUTSIDE. THE PATIENT REPORTS A SURGING SENSATION. THE PATIENT SAID DURING THE CALL THE STIMULATION WAS INCREASING BY ITSELF AND NOW IT WAS TOO STRONG AND SHE WANTS TO DECREASE. THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT REPORTS FOR A COUPLE DAYS HAS STARTED GOING TO THE BATHROOM MORE AND ALSO SAID THAT STIMULATION HAS BEEN INTERMITTENT, FEELS IT SOMETIMES OTHER TIMES SHE DOES NOT. THE PATIENT WAS HAVING A HOT FLASH DURING THE CALL. THE PATIENT ALSO MENTIONED THAT SINCE SHE RECEIVED IMPLANTED SYSTEM HER BREASTS HAVE GROWN 4 TIMES THEIR SIZE. THE PATIENT SAID THAT SHE HAS BEEN TO HER GYNECOLOGIST AND THEY CAN'T DETERMINE CAUSE, WONDERING IF STIMULATION WAS CAUSING HER BREASTS TO GROW. THE PATIENT SAID THAT SHE WAS ALSO BEING SENT TO SEE A DIETICIAN, SAID CAN'T EAT FRUIT, VEGETABLES, BY -PRODUCTS. ADDITIONAL INFORMATION REPORTS A PROBLEM WITH THE PATIENT PROGRAMMER . THE PATIENT STATES THE BACKLIGHT TO THE PROGRAMMER WAS NOT COMING ON. THE PATIENT STATES SHE WAS ALSO SEEING A STRANGE PICTURE IN THE LEFT CORNER OF THE PROGRAMMER. THE PATIENT STATES IT LOOKS SOMETHING SIMILAR TO A BURNT OUT LIGHT WHEN IT'S OFF. THE PATIENT STATES IT LOOKS LIKE AN "L" IN THE CORNER. THE PATIENT NOTICED THIS ISSUE STARTED ON (B)(6) 2014. THE PATIENT HAS FRESH BATTERIES IN THE PROGRAMMER. THE PATIENT TRY TURNING PROGRAMMER OFF AND THEN BACK ON AGAIN. THE PATIENT WAS SEEING THE SYNC ICON. THE PATIENT STATES THIS WAS THE SCREEN SHE WAS SEEING. IT WAS REVIEWED WITH THE PATIENT THAT THIS WAS A NORMAL FUNCTION OF THE PROGRAMMER AND IT'S TELLING HER TO SYNC WITH THE INS (STIMULATOR). THE PATIENT STATES ONCE SHE DOES THIS SHE SEES THE REGULAR PROGRAMMING SCREEN. THE PATIENT CONFIRMS SHE WAS NOW SEEING THE BACKLIGHT COME ON. THE PATIENT STATES IT'S NOW BLACK AND WHITE IN COLOR RATHER THAN BLUE. THE PATIENT STATES SHE WAS STILL ABLE TO SEE THE SCREEN HOWEVER. IT WAS REVIEWED THAT THE PROGRAMMER APPEARS TO BE WORKING AS INTENDED. THE PATIENT ALSO REPORTS SHE WENT TO USE THE PROGRAMMER LAST NIGHT BECAUSE SHE HAD AN ICE CREAM BAR AND SHE SHOULDN'T HAVE. THE PATIENT WAS LACTOSE INTOLERANT AND WAS TRYING DIFFERENT FOODS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT DO HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THEIR BACK PAIN STARTS AT THE SPOT ITS ON SINCE THEY HAD THE DEVICE. THE PATIENT HAD GAIN FIFTY POUNDS AND THREE ¿ILLEGIBLE¿ SIZES. THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT HAD APPOINTMENT FOR (B)(6) 2014. THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014. IT WAS UNCLEAR IF THE PATIENT¿S CONCERNS WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514676 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR