BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2037460 · Received March 11, 2011

    Report

    Report Number
    3004209178-2011-01872
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT ON (B)(6) WHILE WALKING THROUGH THE SECURITY GATE OF (B)(6) WITH STIMULATION ON AT 2.5V/210PW/14HZ. 2-3+; THE PATIENT FELT KNIFE PAIN AT MIDLINE CIRCULAR PAIN. THE UPPER LIMIT WAS SET AT 8.5V. THE PATIENT WENT HOME AND TURNED OFF STIMULATION. STIMULATION HAD BEEN OFF SINCE (B)(6). THE PATIENT CONTINUED TO FEEL THE CIRCULAR MOTION PAIN AT MIDLINE. THE PAIN HAD NOT SUBSIDED OR DECREASED. THE PATIENT'S SKIN LOOKED INTACT, NO REDNESS OR BURNED AREA. WHENEVER THE PATIENT'S RIGHT LEG MOVED FORWARD, SHE COULD FEEL THE LEAD MOVING IN HER BODY. THE STIMULATION WAS CONTROLLING THE PATIENT'S SYMPTOMS. THERE WAS ALSO AN ISSUE REGARDING IMPEDANCE: READING >4000 OHMS ON SOME OF THE BIPOLAR PARIS. ELECTRODE IMPEDANCE TESTED AT 1V/210PW: C0:1423 OHMS, C1:547 OHMS, C2: 1111 OHMS, C3: 1111 OHMS, 01: 1482 OHMS, 02: >4K OHMS, 03: >K OHMS, 12: 1111 OHMS, 13: 1111 OHMS, 23: 1147 OHMS. THE PATIENT WAS AT THE CLINIC AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V558148| PROGRAMMER: MODEL 3037, LOT# NJD113352N