BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3912649 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12495
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 11, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA04A8Q, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BEEN HAVING BURNING PAIN AT RIGHT HIP BY NEUROSTIMULATOR (INS) SITE, RIGHT BELOW IT. IT WAS LIKE A PINCHING PAIN AND SOMETIMES FELT LIKE A LITTLE ZAP. THE PATIENT FIRST NOTICED IT ABOUT 2-3 WEEKS AGO PRIOR TO CALL. THE PATIENT HAD NO FALL OR TRAUMA. IT WAS INDICATED THAT IT STARTED TO HURT BEFORE SHE STARTED AQUATIC THERAPY. NO MEDICAL TESTS WERE PERFORMED. IT WAS NOTED THAT THERE WAS MORE MOVEMENT IN THE POCKET SITE. IT WAS INDICATED THAT THERE WAS NO CHANGE IN STIMULATION OR THERAPY, IT WAS WORKING GOOD. THE PATIENT HAD NOT TURNED STIMULATION OFF TO DETERMINE WHETHER HAVING STIM OFF AFFECTED PAIN AT INS SITE. THE PATIENT HAD NOT HAD X-RAYS YET HOWEVER WILL BE OF BOTH HIPS AND WAS SCHEDULED FOR TRANSDERMAL EPIDERMAL ON (B)(6) 2001. THE PATIENT HAD EPIDERMAL IN S1 AREA AND HCP WANTED PATIENT TO CONSIDER BONE GRAFT AND SPINAL FUSION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389860 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR