BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2767296 · Received October 1, 2012

    Report

    Report Number
    3004209178-2012-08732
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    September 3, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V875334, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT FELL AND HER LEG WAS NUMB DUE TO NERVE DAMAGE FROM THE FALL. IT WAS INDICATED THAT PATIENT FELL AND BROKE THE WHOLE DEVICE, 3 LEADS WERE OFF AND EVERYTHING WAS BROKEN. IT WAS NOTED THAT IT TOOK 10 MONTHS TO GET IN FOR REVISION WITH HEALTH CARE PROVIDER. IT WAS INDICATED THAT NEUROSTIMULATOR INS WAS REPLACED IN (B)(6) 2013. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE ANY CONCERNS WITH THEIR DEVICE AND WAS "VERY SATISFIED." FOUR DAYS LATER, THE PATIENT WAS REPORTED AS "DOING FINE." ADDITIONAL INFORMATION REPORTED THAT INITIALLY THE DEVICE WAS NOT WORKING, EVEN WHEN GOING THROUGH ALL PROGRAMS. THERE WERE NO REVISIONS OR HOSPITALIZATIONS. IT WAS STATED THAT THE PROBLEM WAS "FIXED" ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COULD NOT HIT OR STAND TOO LONG AS IT HURTS. PATIENT FELT A NUMB AND TINGLING FEELING ON HER LEFT SIDE AND DOWN TO HER LEG. PAST TWO TO THREE WEEKS FROM THE DATE OF THIS REPORT, THE WIRES WERE SHOCKING HER. ON PATIENT'S RIGHT SIDE, HER BUTTOCKS DOWN TO HER FOOT AND HER TOES WERE "CURLING IN." THE DEVICE WAS TURNED ON AND PROGRAM 1 AT 4.0. PATIENT HAD SHOCKING IN HER BUTT AT THIS SETTING. IT WAS NOTED THAT PATIENT HAD A FALL ONE MONTH AFTER SHE GOT THE DEVICE. PATIENT HAD BUTT BONE ACHES.

    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 Required Intervention