BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4112258 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17605
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0G6FS, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: UNKNOWN PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4)

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING URGENCY AND LEAKING. THE PATIENT JUST HAD THE INTERSTIM IMPLANT DONE ON MONDAY AND SHE HAD SOME QUESTIONS. INTERSTIM IS FOR BLADDER. THE PATIENT HAS SEVERAL QUESTIONS. THE PATIENT WANTED TO KNOW IF THE STIMULATION WAS WORKING FOR HER. THE PATIENT WAS WONDERING IF IT WORKS RIGHT AWAY OR CAN IT TAKE SOME TIME. THE PATIENT WAS BARELY FEELING ANY STIMULATION. THE PATIENT DID NOT HAVE ANY DIRECTION FROM THE DOCTOR. A DOCTOR APPOINTMENT WAS SCHEDULED FOR NEXT WEDNESDAY. THE PATIENT STATED IT IS HARD TO SAY IF THE STIMULATION HAS WORKED SINCE IMPLANT OR NOT. THE PATIENT NOTICED THAT SHE MAY NOT BE GOING TO THE BATHROOM AS MUCH BUT HAS NOTED THAT SHE IS STILL LEAKING. THE PATIENT DID INCREASE THE STIMULATION BUT SHE WAS ONLY FEELING STIM VERY FAINTLY AND ONLY ONCE IN A WHILE. THE PATIENT VERIFIED THAT STIM WAS CURRENTLY AT 2.4 WITH NO CHECK MARK OR NUMBER IN DICATING SHE ONLY HAS THE CURRENT PROGRAM AVAILABLE. THE PATIENT INCREASED STIMULATION BUT THEN WAS HAVING PAIN IN THE VAGINAL AREA. THE PATIENT THEN DECREASED STIM. THE PATIENT THEN STATED THAT SHE HAS HAD PAIN IN THE VAGINAL AREA SINCE IMPLANT AS WELL. WHEN THE PATIENT DECREASED STIM SHE GOT THE INDICATION THAT SHE CAN NOT LOWER IT. IT WAS LATER REPORTED ON (B)(6) 2014 THAT THE PATIENT HAD BEEN WAKING UP WITH URINE SEVERE "FLOODING" IN THE MORNINGS. THE PATIENT HAD INTERSTIM IMPLANTED TO TREAT URINARY INCONTINENCE BUT SHE NEVER HAD THESE TYPES OF PROBLEMS IN THE MORNING PRIOR TO INTERSTIM. THE PATIENT HAD INCREASED STIM FROM 2.2 TO 2.7 BUT WAS STILL HAVING THE PROBLEMS. PROBLEMS STARTED SUDDENLY ABOUT A MONTH AGO, BUT NOT IMMEDIATELY AFTER IMPLANT. THE PATIENT COULD NOT EVEN GET UP IN THE MORNING WITHOUT IT DRIPPING. THE PATIENT DID NOT FEEL ANY STIMULATION SENSATION EVEN AFTER INCREASING TO 2.7. THE PATIENT INQUIRED HOW HIGH SHE SHOULD INCREASE. PATIENT SERVICES REVIEWED THAT THE PATIENT CAN INCREASE TO A COMFORTABLE LEVEL WHERE SHE CAN FEEL STIM SENSATION IN HER PELVIC FLOOR. THE PATIENT WILL TRY THIS AND MONITOR SYMPTOMS. THE PATIENT DID NOT HAVE ACCESS TO DIFFERENT PROGRAMS. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW- UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591998 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR