BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2923868 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00790
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 2, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V863548, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD CONCERNS ABOUT THEIR DEVICE OR THERAPY AND THEY WERE WORKING WITH THEIR MEDTRONIC REPRESENTATIVE OR DOCTOR. IT WAS ALSO STATED THAT THE PATIENT'S CONCERNS WERE RESOLVED. IT WAS NOT CLEAR IF THE PATIENT'S CONCERNS WERE RESOLVED OR NOT. THE PATIENT HAD APPOINTMENTS SCHEDULED FOR (B)(6) 2013, AND (B)(6) 2013. IT WAS NOTED THAT THE PATIENT'S DOCTOR WAS UNAVAILABLE FOR 2 YEARS, SO THEY WERE GOING TO MEET WITH A DIFFERENT DOCTOR. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT; WHEN THE PATIENT MADE ADJUSTMENTS TO HER STIMULATION, SHE FELT IT FOR A LITTLE BIT AND THEN IT WENT AWAY. IT WAS NOTED THAT IT HAD BEEN LIKE THIS FOR ABOUT A WEEK PRIOR TO THE REPORT. THE REPORTER INDICATED THAT THE PATIENT WAS 'LEGALLY BLIND' AND HAD TROUBLE SEEING THE ICON AND BUTTONS ON THE PATIENT PROGRAMMER. THE PATIENT COULD HOWEVER SEE THE 'LIGHTNING BOLT' ON THE PROGRAMMER SCREEN, AND AS SUCH, THE IMPLANTABLE NEUROSTIMULATOR (INS) APPEARED TO BE ON. IT WAS NOTED THAT THE PATIENT WAS PREVIOUSLY ON PROGRAM 3 WHICH WORKED FOR A WHILE, BUT HAD NEVER REALLY TRIED PROGRAM 1 OR 2. AT THE TIME OF THE REPORT HOWEVER, THE PATIENT WAS ON PROGRAM 4 AT 2.3V. THE PATIENT WAS REPORTED TO HAVE ALSO CHANGED THE BATTERIES TO HER PATIENT PROGRAMMER. THE REPORTER STATED THAT THE PATIENT FELT STIMULATION IN THE WRONG LOCATION; DOWN HER LEG ALL THE WAY TO HER HEEL IF SHE TURNED STIMULATION UP TOO HIGH. THE PATIENT'S HEEL WAS REPORTED TO BE SORE BECAUSE OF THIS AND THE PATIENT WAS WORRIED THIS COULD DAMAGE THE NERVE GOING DOWN HER LEG. THE REPORTER STATED THAT THE PATIENT WAS GOING TO TRY USING PROGRAM 1 OR 2 AND IF THAT DIDN'T WORK, WAS GOING TO CONTACT HER HEALTHCARE PROVIDER (HCP).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. THE DOCTOR REPORTEDLY TOLD THE PATIENT THAT THE BATTERY WAS OKAY BUT THOUGHT THAT THE LEADS MIGHT NOT HAVE BEEN PUT IN CORRECTLY. THE PATIENT FELT STIMULATION IN HER HIP NOT HER VAGINA WHERE SHE SHOULD AND FOR A LONG TIME SHE FELT IT DOWN HER LEG. THIS ISSUE STARTED SHORTLY AFTER THE PATIENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30251 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR