BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2805383 · Received October 26, 2012

    Report

    Report Number
    3004209178-2012-09589
    Event Type
    Injury
    Date Received
    October 26, 2012
    Report Date
    September 27, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE EXTENSION; PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3587A, LOT# L36295, IMPLANTED: (B)(6) 1995, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S REVISION WAS THE DAY OF THE REPORT. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT EXPERIENCED ¿NO STIMULATION SENSATION.¿ IT WAS REPORTED THE PATIENT¿S ¿STIMULATION WAS WORKING GREAT UNTIL A COUPLE YEARS AGO, WHEN HE WAS NOT ABLE TO TURN HIS STIMULATION BACK ON.¿ IT WAS NOTED ¿NO MESSAGES OR ERROR CODES WERE SEEN.¿ IT WAS STATED THE PATIENT¿S PARAMETERS AT THE TIME OF REPORT WERE 0 VOLTS, 450 PW, AND 50 HZ ON ELECTRODES ¿0-1-2+3+¿ WITH STIMULATION OFF. IT WAS NOTED THERE WAS AN ¿IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY MESSAGE DONE¿ AND A ¿LOW¿ INDICATION. IT WAS FURTHER NOTED THE BATTERY LIFE WAS LISTED AS 17.6 MONTHS. THERE WERE NO PREVIOUS LONGEVITY CALCULATIONS AVAILABLE AT THE TIME OF REPORT. IMPEDANCE TESTING REVEALED C3 TO BE >4000 OHMS AND 03 TO RETURN A VALUE OF ???. THE PATIENT WAS REPROGRAMMED WITH THREE DIFFERENT COMBINATIONS (1-2+ UP TO 10.5 VOLTS, C2 UP TO 10.5 VOLTS, AND C+0- UP TO 10.5 VOLTS) AND REPORTED FEELING ¿NO STIMULATION¿ FOR ALL OF THEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT NO STIMULATION SENSATION SINCE APRIL WHEN SHE WAS SEEN FOR REPROGRAMMING AND THEN TWO DAYS LATER IT STOPPED. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS ISSUE. IT WAS INITIALLY REPORTED THAT IMPEDANCES WERE NORMAL, BUT THEN REPORTED AS FOLLOWS: C0 = 833 OHMS, C1 = 3149 OHMS, C2 = 3332 OHMS, C3 = >4000 OHMS, 01 = 1679 OHMS, 02 = > 4000 OHMS, 03 = > 4000 OHMS, 12 = ???, 13 = >4000 OHMS, AND 23 = 1679 OHMS. THE BATTERY STATUS WAS 'OK' AND LONGEVITY STATED 5.2 MONTHS AT MAX OUTPUT. THE PATIENT WAS PROGRAMMED USING ALL ELECTRODES ON THE LEAD AND REPROGRAMMING OF SIMPLE BIPOLAR COMBINATIONS USING C0, 01, AND 23 WAS TRIED, BUT THE PATIENT CONTINUED TO NOT FEEL STIMULATION. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT RECEIVING THERAPY AND BESIDES FROM THE HIGH LEAD IMPEDANCES, NO OTHER MALFUNCTIONS WERE DISCOVERED. THE PATIENT WAS SCHEDULED TO SEE HIS PHYSICIAN ON (B)(6) TO DISCUSS NEXT STEPS. FURTHER INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT FEEL STIMULATION AT MAX OUTPUT AND THE EVENT WAS ATTRIBUTED TO THE DEVICE AND LEAD. IT WAS NOTED THAT ON (B)(6) 2012 REPROGRAMMING OF THE OUT-OF-RANGE IMPEDANCES WAS DONE, BUT WAS UNABLE TO PROGRAM AROUND. THE PATIENT DID NOT HAVE STIMULATION AT THIS TIME. THE PATIENT'S SYMPTOMS WERE REPORTED AS THE PATIENT DID NOT HAVE STIMULATION AND HAD BEEN WITHOUT THERAPY SINCE (B)(6) 2012. THE DEVICE PROGRAMMER SESSION OF (B)(6) PRINTOUT INDICATED THE IMPEDANCES AS FOLLOWS: C0 = 1192 OHMS, C1 = 3332 OHMS, C2 = >4000 OHMS, C3 = >4000 OHMS, 01 = 1679 OHMS, 02 = 3332 OHMS, 03 = > 4000 OHMS, 12 = 1679 OHMS, 13 = 3332 OHMS, AND 23 = 1679 OHMS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTER SAW AN ELECTIVE REPLACEMENT INDICATOR (ERI). THE REPORTER DID NOT KNOW WHEN THE ERI OCCURRED. THE PATIENT WAS STILL GETTING GOOD STIMULATION, BUT WAS SCHEDULED FOR A REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS CHECKED FOR IMPEDANCES PREOPERATIVE AND FOUND NONE OUT OF RANGE. THE IMPLANT WAS CONFIRMED TO BE AT ERI. IT WAS REPORTED THAT THE PATIENT HAD NOT FELT STIMULATION IN THEIR PAINFUL AREAS FOR OVER A YEAR. IT WAS REPORTED THAT DURING INTRAOPERATIVE THE BATTERY WAS REMOVED. IT WAS REPORTED THAT IMPEDANCES WERE WITHIN RANGE, HOWEVER PATIENT FELT NO STIMULATION EVEN WITH 10.5 V AND 520 PULSE WIDTH. IT WAS REPORTED THAT IMAGING SHOWED DEGENERATIVE SPINE THAT THE DOCTOR DID NOT FEEL HE COULD DO MUCH TO REVISE LEADS OR PLACE NEW ONES. REPLACEMENT WAS ABORTED. IT WAS REPORTED THAT REGISTERED LEAD AND PORTION OF EXTENSION WERE LEFT IN THE PATIENT. PATIENT WAS NO LONGER RECEIVING SPINAL CORD STIMULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention