BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2689472 · Received August 9, 2012

    Report

    Report Number
    3004209178-2012-06697
    Event Type
    Injury
    Date Received
    August 9, 2012
    Report Date
    July 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3093-33, LOT# V142285, IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6); PROGRAMMER MODEL 3037, SERIAL# (B)(4); LEAD MODEL 3889-33, LOT# VA00BKJ, IMPLANTED: 2012 -(B)(6), EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP WAS UNABLE TO PLACE THE PATIENT'S ORIGINAL LEAD IN S3 DUE TO THE PATIENT'S ANATOMY. THE LEAD ONLY PROVIDED THERAPY RESPONSE ON ONE ELECTRODE, AND THE PATIENT EXPERIENCED LIMITED BENEFIT, SO A SURGICAL INTERVENTION TO PLACE ANOTHER LEAD WAS PERFORMED. THE PLACEMENT OF THE SECOND LEAD LOOKED GOOD, BUT THE LEAD ONLY PROVIDED MOTOR RESPONSE ON ONE, MAYBE TWO, ELECTRODES. THE HCP HAD TRIED REPOSITIONING THE LEAD TO GET BETTER RESPONSE, BUT THE PATIENT WAS EXPERIENCING THE SENSORY SENSATION MORE RECTALLY. IT WAS LATER REPORTED THAT FLUOROSCOPY WAS USED TO OBTAIN GOOD PLACEMENT AND MOTOR RESPONSE WAS SEEN ON THREE OF FOUR ELECTRODES. IMPEDANCE TESTING WAS NORMAL, PROGRAMMING WENT WELL, AND THE PATIENT WAS DOING FINE. NO ADDITIONAL INTERVENTION WAS PLANNED. THE MANUFACTURER'S DEVICE REGISTRY ALSO SHOWED THAT THE PATIENT'S OLD LEAD WAS EXPLANTED AT THE TIME THE NEW LEAD WAS IMPLANTED, AND THE PATIENT'S NEUROSTIMULATOR WAS REPLACED DURING THE SAME PROCEDURE.

    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