BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 4

    MDR report key: 4914890 · Received July 15, 2015

    Report

    Report Number
    3007566237-2015-01966
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Report Date
    July 10, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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 MEDICAL PRODUCTS: PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-33, LOT# L68811, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT HAD THEIR DEVICE REPLACED THE PATIENT WENT HOME THE DAY OF THE CHANGE OUT AND DID NOT HAVE THERAPY UP TO 10 VOLTS. THE MANUFACTURER¿S REPRESENTATIVE (REP) ALSO NOTED A QUESTION ON SCROLL WHEEL USE WHICH WAS RESOLVED ON THE CALL. THE REP. MET WITH THE PATIENT ON (B)(6) AND IMPEDANCE TESTING WAS DONE WITH RESULTS AS FOLLOWS: C/0 575, C/1 523, C/2 25355, C/3 544, 0/1 713, 0/2 29350, 0/3 873, 1/2 12404, 1/3 804, 2/3 22798. THE PATIENT WAS PROGRAMMED WITH C+2-. THE PATIENT WAS PROGRAMMED WITH C+1- AND GOT GOOD RESULTS. THE PATIENT WAS CURRENTLY AT 3.4 VOLTS, 420 PULSE WIDTH, C+1-, R 40 AND THERAPY IMPEDANCE OF 523. THE REP. STATED THEY WOULD KEEP ANY EYE ON IMPEDANCES BUT FOR NOW THERE WAS GOOD THERAPY WITH PROGRAMMING AROUND THE SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460246 ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37703

    Patients

    Seq Age Sex Outcome Treatment
    1