BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3230482 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11874
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 25, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V548215, IMPLANTED: (B)(6) 2010: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT BEGAN TO HAVE A RETURN OF SYMPTOMS ABOUT A MONTH AGO. THERE WAS NO KNOWN EVENT OR TRAUMA THAT MIGHT HAVE CONTRIBUTED TO THE LOSS OF EFFECT. IT WAS STATED THAT ¿FOR WHATEVER REASON, THE PATIENT THOUGHT THEIR LEAD HAD MOVED.¿ THE PATIENT THOUGHT THAT LEAD MIGRATION OR BATTERY LOSS WAS CAUSING THE LOSS OF EFFECT. IT WAS NOTED THE PATIENT WAS ALSO FEELING PAIN THAT GOES DOWN TO THEIR HEEL. THE PATIENT HAS FELT THIS PAIN FOR ABOUT A MONTH AND A HALF AND WOULD FEEL THE PAIN WHEN THEY WERE WALKING. IT WAS INDICATED THE PATIENT WAS ON PROGRAM 1 AT 2.2V. MORE THAN ONE MONTH LATER IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE/THERAPY, BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS STATED THAT THE PATIENT WAS AWAITING AN APPOINTMENT FOR DEVICE REMOVAL. IT WAS REPORTED THAT IT SENT RANDOM SPARKS IN LEG OR FOOT AND IT FELT LIKE GENITALS WERE PINCHED AND AN ELECTRODE WAS IN PATIENT'S "REAR." IT WAS STATED THAT THE DEVICE HAD BEEN TURNED OFF 3 WEEKS PRIOR TO THE REPORT AND THAT THE PATIENT COULDN'T HAVE MRI NEEDED FOR HER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329543 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR