BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 4896431 · Received July 7, 2015

    Report

    Report Number
    3004209178-2015-12907
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION FELT LIKE IT WAS ALWAYS ON. EVEN WHEN THEY HAD TURNED IT OFF, THEY FELT LIKE IT TURNED BACK ON. THEY NOTED THAT WHEN STIMULATION WAS ON THEY HAD GOOD THERAPY. THE BATTERY MEASUREMENT WAS NORMAL WITH 39.6 MONTHS REMAINING. THE MANUFACTURER REPRESENTATIVE (REP) PERFORMED REPROGRAMMING TO SEE IF IT WOULD HELP THE PATIENT'S STIMULATION. THE DEFAULT AMP WAS 1.5 AND 210US. IMPEDANCE MEASUREMENTS WERE; C0, C1=>4000, C2=???, C3= 369, 01=???, 02=>4000, 03=>4000, 12=1537, 13=2876, 23=???. THEY WERE PROGRAMMED TO 31 HZ. THE PATIENT HAD HAD A SURGERY WITH ELECTROCAUTERY THE PREVIOUS DECEMBER BUT THERE WERE NO ISSUES AFTERWARDS. IT WAS LATER NOTED THAT THE REPROGRAMMING DID NOT HELP THE ISSUE. THE STIMULATOR WAS BEING LEFT OFF FOR NOW AND THE PATIENT WAS DECIDING WITH THE DOCTORS WHAT THEY WOULD LIKE TO DO MOVING FORWARD. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439595 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR