BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5140672 · Received October 9, 2015

    Report

    Report Number
    3004209178-2015-20238
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Report Date
    September 11, 2015
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V842736, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAD SEVERE PAIN IN THE BACK/LEG AND AROUND THE IMPLANT AREA. THE PAIN OCCURRED IN (B)(6) 2015. THE TERRIBLE SHOOTING PAINS SEEMED TO COME FROM THE IMPLANT SITE. THE PAIN WAS SO BAD THAT SHE WANTED THE DEVICE REMOVED OR TURNED OFF. SHE HADN'T BEEN UNABLE TO TURN OFF THE DEVICE SINCE THEN. THE PATIENT HAD BEEN HAVING PROBLEMS WITH THE TERRIBLE SHOOTING PAINS FOR A "WEEK OR TWO WEEKS". THE PATIENT'S HEALTH CARE PROVIDER (HCP) PRESCRIBED A MEASURED DOSE OF MILD PREDNISONE AND MUSCLE RELAXERS. THE PATIENT STATED THAT SHE ONLY HAD ONE PROGRAM AVAILABLE AND NEEDED OTHER PROGRAMS BECAUSE SHE DIDN'T FEEL STIMULATION AT 3.3. V. THE PATIENT TURNED OFF THE UNIT WHEN SHE RECEIVED A NEW CONTROLLER AND HAD NOT TURNED THE UNIT BACK ON SINCE THEN. THE HCP WAS ARRANGING AN APPOINTMENT WITH ANOTHER HCP THAT WAS FAMILIAR WITH THE DEVICE. THE PATIENT'S CIRCUMSTANCES WERE NOT UNUSUAL EXCEPT FOR REGULAR HOUSECLEANING. THE INDICATIONS FOR USE WERE URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671145 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR