BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4100957 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17343
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0BKAY, IMPLANTED: (B)(6) 2013, 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 HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT¿S THERAPY WORKED INITIALLY, BUT BECAME LESS EFFECTIVE WHEN THEY WERE SWITCHED FROM PROGRAM TWO TO THREE. THE PATIENT HAD TO SWITCH TO A HEAVIER PAD AT NIGHT. THREE DAYS PRIOR TO CALL, THE PATIENT LOST CONTROL OF THEIR BLADDER AND WET THEIR PANTS. THE PATIENT INCREASED STIMULATION TO SEE IF THAT RESOLVES THE ISSUE. THE PATIENT HAD FELT ELECTROCUTED OR SHOCKED ON PROGRAM THREE WHEN GOING FROM A SITTING TO A STANDING POSITION. THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT CALLED CUSTOMER SUPPORT AND WAS GIVEN GOOD HELP BY CHANGING THEIR PROGRAM TO NUMBER 4.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT CALLED SEVERAL WEEKS AGO AND WAS TOLD IF SHE NEEDED ASSISTANCE TO CHANGE PROGRAM TO CALL PATIENT SERVICES. SINCE CALLING THE LAST TIME, THERAPY HAD NOT IMPROVED AND SHE WAS STILL HAVING PROBLEMS. EVERYDAY AROUND 4PM THE PATIENT FEELS ELECTROCUTED / ELECTRIC CHARGES AND "SENDS HER PUT THE WALL" AND IT LASTS UNTIL BEDTIME. THE MORNINGS WERE FINE BUT EVENINGS WERE NOT. SOMETIMES THE PATIENT GOES 3 TIMES IN HALF HOUR AND THEN IT DOESN'T HAPPEN AGAIN. THE PATIENT MET HCP (HEALTHCARE PROVIDER) IN (B)(6) AND TOLD HCP SHE WAS TESTING SETTING AND HOPED IT WOULD BE BETTER. CURRENT SETTING WAS 3.7V. THE PATIENT DID NOT KNOW HOW TO CHANGE PROGRAM. THERAPY WAS DOING FINE RIGHT NOW BUT AROUND 4PM STARTS TO GET ELECTROCUTED, IS TOO STRONG, AND LASTS UNTIL BEDTIME. THE PATIENT DID NOT REMEMBER IF SHE DISCUSSED WITH HCP. THE MANUFACTURER'S REPRESENTATIVE HELPED HER A WHILE GO TO PROGRAM 3. THE PATIENT NOTED THE PATIENT PROGRAMMER BATTERY ICON SHOWED THE PATIENT PROGRAMMER BATTERY WAS LOW. THE PATIENT CHANGED THE BATTERY ON PATIENT PROGRAMMER. SETTING WAS PROGRAM 3 AT 3.7V. PATIENT SERVICES ASSISTED THE PATIENT TO CHANGE TO PROGRAM 4 AT 1.5V. THE PATIENT PLANNED TO TRY SETTING. THE PATIENT HAS TO RIDE AN ELECTRIC CHAIR TO GET AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584996 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Other