BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3222770 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11664
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 26, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA07A6C, IMPLANTED: (B)(6) 2013. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S DEVICE WAS STILL TURNED OFF BECAUSE EVERY TIME SHE TURNED IT ON IT ¿ZAPPED HER IN THE PRIVATE AREA.¿ THE PATIENT¿S SYMPTOMS OF FREQUENCY WERE BACK EVERY FEW MINUTES.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT HAD AN OVERSTIMULATION SENSATION AND A SHOCKING OR JOLTING SENSATION. IT WAS STATED IT HURT THE PATIENT WHEN THEY TURNED IT ON AND STATED "AS SOON AS I TURN THE STIMULATION UP, IT IMMEDIATELY HURTS AND FEELS LIKE IT¿S STABBING ME IN THE RIGHT SIDE OF MY PRIVATE AREA AND I CAN¿T SIT DOWN OR LAY DOWN". IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND WERE STILL HAVING FREQUENCY AND LEAKAGE PROBLEMS. IT WAS NOTED THE PATIENT STATED "AT FIRST IT WAS WORKING BEAUTIFULLY.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THREE DAYS BEFORE THE REPORTED EVENT THAT THE PATIENT WAS NOT FEELING ANY STIMULATION SO THE PATIENT INCREASED STIMULATION FROM 1.5 TO 1.7. IT WAS STATED THAT THE PATIENT NORMALLY FEELS STIMULATION THROUGHOUT THE DAY AND WHEN PATIENT SITS. WHEN THE PATIENT INCREASED STIMULATION, THE PATIENT REPORTEDLY DID NOT FEEL A STIMULATION SENSATION BUT A SHOCKING FEELING IN THE RIGHT ARM AND THE RIGHT LEG. IT WAS STATED THAT THE PATIENT EXPERIENCED GETTING ¿ELECTROCUTED¿ ON THE RIGHT SIDE OF THE BODY. THE PATIENT REPORTEDLY WAS EXPERIENCING LEAKING AGAIN, AND GOING TO THE BATHROOM CONSTANTLY. IT WAS NOTED THAT THERE WAS PAIN AT THE IMPLANT SITE AND THE PATIENT WAS FEELING A LOT OF PRESSURE ¿IN HER PRIVATE AREA.¿ THE PATIENT¿S STIMULATOR WAS AT 2.0 VOLTS AND THE PATIENT FELT NOTHING. IT WAS ALSO NOTED THAT THE PATIENT WAS IN A KIDDY POOL AND SLIPPED AND WAS ¿FLUNG¿ OUT OF THE POOL TWO DAYS BEFORE REPORTED EVENT. IT WAS REPORTED LATER THAT DAY THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT THREE DAYS PRIOR TO REPORT. THE PATIENT WAS AT 1.9 VOLTS WHEN THE PATIENT REPORTEDLY FELT SHOCKED AND THE DEVICE STOPPED WORKING. IT WAS NOTED THAT THE BLADDER WAS CHECKED VIA ULTRASOUND TO MAKE SURE THE PATIENT WAS NOT IN RETENTION. THE HEALTHCARE PROVIDER DID NOT HAVE ACCESS TO A CLINICIAN PROGRAMMER. IT WAS ALSO NOTED THAT THE PATIENT PROGRAMMER WAS SHOWING PROGRAM 1 AT 1.1 VOLT AND THEN STIMULATION WAS INCREASED UP TO 2.0 VOLTS. THE PATIENT FELT UNCOMFORTABLE STIMULATION WITH INCREASED STIMULATION, THEN IT WAS TURNED BACK TO 1.9 VOLTS BUT THE PATIENT STILL EXPERIENCED A PRESSURE FEELING AND WAS NOT COMFORTABLE. IT WAS NOTED THAT THE PATIENT HAD NO DIRECTION ON VOIDING DIARY. THE STIMULATOR WAS CHANGED TO PROGRAM 2. THE STIMULATOR WAS TURNED UP AND THE PATIENT FELT STIMULATION BUT WAS NOT COMFORTABLE. THE PATIENT STILL FELT PAIN WITH THE STIMULATION UP AT 1.2 VOLTS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHEN THERAPY IS TURNED OFF. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT EXPERIENCED "ELECTROCUTION" IN RIGHT SIDE ON THE BODY ON (B)(6) 2013 WHILE LYING IN BED. IT WAS NOTED THAT THE PATIENT WAS SEEN AT THE HEALTHCARE PROVIDER OFFICE ON (B)(6) 2013 AND AN ULTRASOUND AND URINE TEST WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT HAD NO URINARY TRACT INFECTION. IT WAS REPORTED NO STIMULATION SENSATION AND THE PATIENT TUNED THE STIMULATOR UP TO PROGRAM 2 DAY BEFORE AND FELT NO TINGLES, NOTHING DIFFERENT. IT WAS NOTED THAT THE PATIENT HAD BEEN TRACKING SYMPTOMS AND STILL ¿PEEING EVERY 2 MINUTES." IT WAS NOTED THAT IT WAS ¿HURTING¿ WHERE THE STIMULATOR WAS IMPLANTED. IT WAS NOTED THAT THE SYMPTOMS HAD ALREADY STARTED BEFORE THE PATIENT FELL ON THE POOL ON (B)(6) 2013. IT WAS ALSO NOTED WHEN THE STIMULATOR WAS WORKING THERE WAS NO PAIN, NO LEAKING AND THE PATIENT WAS URINATING LIKE NORMAL. IT WAS LATER REPORTED THAT THE PATIENT TURNED OFF THE DEVICE AND WILL MAKE AN APPOINTMENT TO HAVE THE DEVICE INTERROGATED AT THE HEALTHCARE PROVIDER OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322612 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR