BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 3819203 · Received May 19, 2014

    Report

    Report Number
    6000032-2014-00104
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 3982, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE LEAD; PRODUCT ID 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1993, PRODUCT TYPE EXTENSION; PRODUCT ID 7433, SERIAL# (B)(4), IMPLANTED: (B)(6) 1991, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTER WAS WITH THE PATIENT TO TROUBLESHOOT THE SYSTEM. IT WAS NOTED THE PATIENT WAS COMPLAINING OF BURNING WHERE THE LEAD WAS. IT WAS NOTED THE PATIENT HAD NOT RUN IT IN 8 MONTHS. THE REPORTER NOTED THAT WHEN THE IMPLANT WAS OFF, THE PATIENT STILL HAD BURNING, BUT IT WAS NOT AS FREQUENT. WHEN THE PATIENT LAID ON THE SHOULDER OF THE RIGHT SIDE, HE GOT BURNING AND PAIN WHEN GETTING UP. IT WAS NOTED THAT THE BURNING STARTED 10 MONTHS TO 1 YEAR PRIOR TO THE REPORT. THE PATIENT HAD KEPT THE IMPLANT OFF FOR ABOUT 8 MONTHS AND THE PAIN WAS GETTING WORSE. IT WAS NOTED THAT THERAPY IMPEDANCE WAS 1035 AND 94UA AND THAT THE PATIENT WAS PROGRAMMED TO 0+, 1-, 2-. IT WAS NOTED THE BATTERY READING WAS 3.58V. THE REPORTER INDICATED THAT THE PATIENT WAS ABLE TO FEEL STIMULATION WHEN THE IMPLANT WAS TURNED ON, BUT THE STIMULATION WAS ON THE PATIENT¿S LEFT SIDE INSTEAD OF THE BACK AREA. IT WAS NOTED THAT THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN 3 WEEKS PRIOR TO THE REPORT. ELECTRODE IMPEDANCE TEST WAS AS FOLLOWS: 0C 695 1C 1165 2C 691 3C 1212 01 1658 02 1008 03 1681 12 1593 13 >2000, 10UA 23 1614 ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DECIDED NOT TO HAVE THE IMPLANT TAKEN OUT. IT WAS NOTED THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297717 ITREL II STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1