BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2853280 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-11000
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 5, 2012
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V952173, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT THE STIMULATION WORKED FOR HER SYMPTOMS FOR THE FIRST TWO MONTHS. THE PATIENT THEN SAW HER HEALTH CARE PROVIDER (HCP), WHO READ HER DEVICE, AND SINCE HAD HAD ACCIDENTS. THE PATIENT FELT STIMULATION AT 0.6 VOLTS, BUT STILL HAD ACCIDENTS. THE PATIENT WAS ASSISTED IN TURNING UP TO 1.3 VOLTS ON A DIFFERENT PROGRAM AND WAS COMFORTABLE. THE PATIENT PLANNED TO SEE A NEW HCP ON (B)(6) 2012 BECAUSE SHE FELT HER OLD HCP DID NOT FEEL 'INTO HER APPOINTMENTS.' ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT WAS FEELING PAIN. THE PATIENT HAD TURNED UP HER STIMULATION EARLIER THAT DAY AND SINCE FELT PAIN IN HER BOTTOM WHEN SHE MOVED AROUND. THE PATIENT ALSO STATED SHE FELT PAIN BEFORE SHE INCREASED THE STIMULATION; SHE SOMETIMES FELT PAIN WHEN SHE LIED IN BED AND FELT PAIN THE DAY PRIOR TO THE REPORT WHEN SHE WAS STANDING. THE PATIENT STATED SHE FELT STIMULATION IN HER 'BIKE SEAT AREA AND ON THE LEFT SIDE BOTTOM.' THE PATIENT ALSO STATED SHE NEVER CHANGED TO A NEW PROGRAM, HOWEVER EARLIER THAT DAY SHE WAS ASSISTED IN DOING SO. THE PATIENT STATED SHE WAS MORE COMFORTABLE AT 1.2 VOLTS. THE PATIENT STATED SHE DID NOT WANT TO MAKE THE NEW HCP AWARE OF THE SITUATION BECAUSE 'THEY MIGHT NOT TAKE HER ON AS A PATIENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT HAD A 'SHOCKING OR JOLTING SENSATION.' THE PATIENT WAS 'PUSHING HER BEHIND AGAINST HER PILLOW OF HER HUSBAND'S CAR SEAT, PUTTING PRESSURE ON THE STIMULATOR AND IT STARTED SHOCKING A LOT, GOING PPPRRRRRRRRR.' THE PATIENT STATED THIS HAD NEVER HAPPENED BEFORE AND AFTER SHE HAD INCREASED HER STIMULATION IT HAD CALMED DOWN, THEN ALL OF THE SUDDEN IT JUST 'PPPPRRRR.' THE PATIENT FURTHER DECREASED TO 1.1 VOLTS. THE PATIENT ALSO STATED SHE WAS TAKING SWIMMING LESSONS AND EVERY TIME SHE WENT INTO WATER, SHE GOT 'SHOCKED.' THE PATIENT THEN STATED SHE GOT 'SHOCKED' AFTER BATHES AND ANSWERED 'YES, YES, IT HAD ALWAYS HAPPENED. IT HAD HAPPENED BEFORE, YEAH.' THE PATIENT MENTIONED SHE DID YOGA AND STATED SHE WOULD NOT DO IT ANYMORE TO PREVENT STRAIN ON HER LEADS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1