BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2955289 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02518
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    February 1, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V639199, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT WAS HAVING LEAKAGE. IT WAS NOTED "THEY FIRST TRIED TO IMPLANT IN THE OFFICE, BUT IT WAS TOO PAINFUL". IT WAS FURTHER STATED "THEY PUT A LEAD ON ONE SIDE", BUT THE PATIENT COULD NOT TAKE THE PAIN. IT WAS UNCLEAR EXACTLY WHAT WAS BEING REFERRED TO IN THE PREVIOUS SENTENCES. IT WAS INDICATED THE PATIENT TRIED ADJUSTING SETTINGS/"MOVING IT AROUND" FOR A COUPLE OF MONTHS, BUT THIS DID NOT HELP THEIR SYMPTOMS. PAIN AT THE IMPLANT SITE WAS ALSO REPORTED. IT WAS NOTED THAT STIMULATION IN THE WRONG LOCATION WAS FELT. IT WAS ALSO PAINFUL FOR THE PATIENT WHEN STIMULATION WAS INCREASED. IT WAS REPORTED THE PATIENT WAS NOTIFIED BY THE MANUFACTURER REPRESENTATIVE IN (B)(6) 2012 THAT THE LEADS "WERE NOT IN THE RIGHT SPOT". IT WAS INDICATED THE LEADS WERE IN THE PATIENT'S BUTTOCKS, BUT NOT THEIR BLADDER. THE PATIENT'S STIMULATION HAD BEEN OFF SINCE (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT DEVICE WAS STILL NOT WORKING AND WAS CAUSING PAIN DESPITE HAVING IT TURNED OFF FOR ALMOST 2 YEARS. IT WAS INDICATED THAT PATIENT HAD SEVERED PAIN IN HER BACK GOING DOWN THE LEG AND CAN HARDLY WALK. THE PATIENT STATED, SHE WAS NOT TRAINED ADEQUATELY ON USING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58666 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1