BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4123321 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17843
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 6, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0FW16, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT INCREASED HER SETTING UP AND IT WAS TOO STRONG AND WONDERS IF SHE SHOULD BRING THE SETTING BACK DOWN. THE PATIENT DIDN¿T HAVE THERAPEUTIC EFFECT BEFORE AND MET WITH MANUFACTURE REPRESENTATIVE . THE EVENT OR SYMPTOMS OCCURRED FOLLOWING A POSITION CHANGE OR BENDING OVER OR DOING AN ACTIVITY. WHEN SHE WAS SITTING IT DOESN¿T SEEM TO BOTHER HER. THE STIMULATION WAS HURTING HER WHEN SHE WAS WALKING, BENDING OVER OR DOING AN ACTIVITY. IT STARTED YESTERDAY AND WAS GETTING WORSE. MOVEMENT DOES CAUSE STIMULATION CHANGES. IT WAS NOTED EDUCATION ON PATIENT PROGRAMMER USE RESOLVED THE REPORTED ISSUE. THE PATIENT TURNED STIMULATION BACK DOWN TO WHERE IT WAS BEFORE AND WHEN SHE GETS UP, IT BEATS AT HER AND WHEN SHE SITS DOWN THERE WAS NOTHING. WHEN THE PATIENT GOT HOME YESTERDAY IT WAS PRETTY STRONG WHEN SHE WAS UP AND AROUND AND THEN FELT SLIGHTLY WHEN SHE SAT DOWN, BUT NOTHING SHE WASN¿T ABLE TO LIVE WITH. NOW IT WAS TOO STRONG WHEN SHE WAS UP WALKING AROUND. STIMULATION AT 0.55 VOLTS AND CAN¿T REMEMBER IF IT WAS 0.50 VOLTS. SHE CAN¿T RECALL WHAT HER SETTING WAS WHEN SHE GOT HOME YESTERDAY. THE PATIENT FELT SHE NEEDED TO INCREASE IT WHEN SHE WAS SITTING. THE REPRESENTATIVE CHECKED THE STIMULATION THE DAY BEFORE REPORTED EVENT DATE AND THE REPRESENTATIVE CHANGED IT WITH PATIENT PROGRAMMER. THE PATIENT MEET WITH THE REPRESENTATIVE BECAUSE SHE WASN¿T GETTING ANY RESULTS WITH IT AND WETTING ON HERSELF AND RUNNING DOWN HER LEGS. SHE HAD NO CONTROL AT ALL AND WAS DISGUSTED WITH IT. IT WAS NOTED THE PATIENT DOESN¿T KNOW HOW SOON SHE WAS SUPPOSED TO BE SEEING RESULTS. SHE FAINTED FROM DIZZY SPELL, GOT AN BLADDER INFECTION THAT PUT HER IN THE HOSPITAL AND THEN 3 WEEKS IN A CARE CENTER. THE PATIENT THINKS SHE HAD THE BLADDER INFECTION LAST MONTH BUT CANNOT REMEMBER. THE PATIENT WENT TO THE HEALTHCARE PROVIDER OFFICE AND TOLD THEM SHE THOUGHT SHE WAS GETTING A BLADDER INFECTION BECAUSE SHE HAS HAD THEM BEFORE. THE HEALTHCARE PROVIDER TOOK SPECIMEN AND TOLD THE PATIENT SHE HAD AN INFECTION AND GAVE ANTIBIOTIC. THE PATIENT WAS IN AN AMBULANCE WHEN SHE WENT TO THE HOSPITAL. SHE WAS WET WHEN SHE LEFT HER HOME AND COULDN¿T WAKE THE PATIENT UP AND SENT THE PATIENT INTO THE HOSPITAL AND FELT THAT PATIENT WET HERSELF ON THE WAY TO THE AMBULANCE AND THEN PUT FOLEY INTO PATIENT. THE PATIENT THINKS THAT WAS A MONTH AGO AND SINCE THEN PATIENT DOESN¿T HAVE ANY CONTROL OVER IT AT ALL AND URINE POURS OUT OF HER WHEN SHE STANDS UP OR GETS OUT OF BED IN THE MORNING AND WHY SHE CALLED REPRESENTATIVE AND MET REPRESENTATIVE TO SEE IF THEY COULD GET THE THING SET IN BETWEEN THE TWO SETTINGS WHERE ONE SETTING WAS TOO MUCH AND THE OTHER SETTING WAS TOO LITTLE. SHE HAD IT UP AT 0.70 VOLTS AND THAT WAS TOO HIGH AND REASON SHE DECREASED DOWN TO 0.55 VOLTS DURING LUNCH AND WHEN SHE WAS SITTING IT DOESN¿T BOTHER. IT WAS REPORTED TWELVE DAYS LATER THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. APPOINTMENT WAS NOTED WITH REPRESENTATIVE ON (B)(6). IT WAS ALSO REPORTED THAT THE PATIENT SILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAVE NOT SOUGHT FURTHER HELP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS ON A SCHEDULE. "I'M IN THE LAST WEEK OF 'ABSTINENCE'." THE PATIENT SAW THE DOCTOR LAST FRIDAY "AND HE HAD NO FURTHER INSTRUCTIONS FOR ME. THE ONLY THING HE CAN TRY NOW IS INJECTIONS INTO MY ANKLE, BUT I'M HAVING SURGERY ON MY SHOULDER ON (B)(6)." THE PATIENT WONDERED IF THEY SHOULD GO BACK ON "3 OR 4 OF THE SCHEDULE SHE GAVE ME. OR, WHAT I'M SUPPOSED TO DO NOW WHEN I FINISH WITH MY SECOND WEEK OF NOT DOING ANYTHING. THE PATIENT NOTED: "THEY ARE TRYING TO REGULATE IT, BUT IT HAS NOT BEEN REGULATING TOO WELL. SHE HAD ME ON THIS 2 WEEKS ON EACH ONE OF THESE PROGRAMS. I NEED TO TALK TO HER TO SEE WHERE I GO FROM HERE." REGARDING SYMPTOMS, IT WAS NOTED: YES. LOSS OF BLADDER CONTROL WAS NOTED. PATIENT SERVICES WAS UNSURE WHEN THE REPRESENTATIVE BECAME AWARE OF RETURN OF SYMPTOMS OR HOW LONG THE REPRESENTATIVE HAD BEEN WORKING WITH THE PATIENT ON A "SCHEDULE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602747 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R