BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 4

    MDR report key: 3002080 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03643
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 2, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-28, LOT# J0225319V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT'S DEVICE WAS REPLACED, THE PATIENT WAS RECEIVING GOOD STIMULATION AND GOOD THERAPY. PLEASE REFER TO MFR. REPORT NO. 6000032-2013-00059 REGARDING PATIENT'S PREVIOUS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES AND A LOSS OF STIMULATION FOLLOWING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY. IT WAS STATED THAT THE IMPEDANCE READINGS WERE GREATER THAN 40,000 OHMS MEASURED AT THREE VOLTS, AND IT WAS AFFECTING THE CASE PAIRS ONLY. IT WAS ALSO STATED THAT ALL UNIPOLAR COMBINATIONS WERE GREATER THAN 40,000. THE FOLLOWING BIPOLAR IMPEDANCES WERE REPORTED: '01 =1400, 02=2300, 03=3300, 12=1400, 13=1300, 23=2300' (THE CALLER ROUNDED THE NUMBERS). THE CALLER STATED HE SAW 'GREATER THAN >4,000 IMPEDANCES ON PREVIOUS INS, HOWEVER, CALLER THEN REPORTED PATIENT LOST THERAPY APPROXIMATELY THREE WEEKS PRIOR TO REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104677 ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37703

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR