BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 5169494 · Received October 22, 2015

    Report

    Report Number
    3004209178-2015-21280
    Event Type
    Malfunction
    Date Received
    October 22, 2015
    Report Date
    September 30, 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 7495-25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 7434-E, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A, LOT # J0015903V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) THAT REPORTED THEY RAN IMPEDANCES AND WAS GETTING QUESTIONS MARKS, ???, AND WANTED TO KNOW ABOUT INTERPRETING THE IMPEDANCE RESULTS. THE DEFAULT TEST VALUES WERE INCREASED AND THE TEST WAS RE-RUN AT 2.5 VOLTS AND 210 MICROSECONDS AND WAS AS FOLLOWS: C0 454 OHMS, C1 454 OHMS, C2 497 OHMS, C3 2816 OHMS, 01 549 OHMS, 02 693 OHMS, 03 2816 OHMS, 12 609 OHMS, 13 2816 OHMS, AND 23 2816 OHMS. IT WAS REVIEWED THAT PAIRS WITH ELECTRODE THREE WERE HIGH. THE PATIENT WAS PROGRAMMED WITH PAIR 1 AND 2 AND THEIR THERAPY SETTINGS WERE 3.2 VOLTS, PULSE WIDTH 360 MICROSECONDS, AND A RATE OF 40 HERTZ. THE BATTERY WAS ALSO READING END OF LIFE (EOL) AND THE ESTIMATE WAS 46.3 MONTHS. IT WAS REVIEWED THAT AT EOL THE REP. WOULD NEED TO DISCUSS OPTIONS FOR REPLACEMENT THE BATTERY ESTIMATE ON THE CLINICIAN PROGRAMMER BECOMES INACCURATE AND WOULD DISPLAY A NUMBER THAT WASN¿T USEFUL IN PREDICTING REMAINING BATTERY LIFE. PRIOR TO THE APPOINTMENT THE PATIENT DIDN¿T HAVE ANY COMPLAINT AND DIDN¿T NOTICE ANYTHING UNUSUAL ABOUT STIMULATION. THE REP. FURTHER REPORTED THAT THE PATIENT¿S INS WAS GOING TO BE REPLACED BUT PER THE PHYSICIAN A REPLACEMENT WOULD BE SCHEDULED WHEN THE PATIENT STOPPED RECEIVING THERAPY AND IT DIED COMPLETELY. AT THE TIME OF THE REPORT THE REP. REPORTED THAT THE BATTERY HAD NOT DIED YET THEY ASSUMED SINCE THEY HAD NO FURTHER CONTACT. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE REPORTED THE CLINICIAN PROGRAMMER WAS STILL SHOWING AN END OF LIFE (EOL) MESSAGE BUT THE LONGEVITY UNDER BATTERY INFORMATION SHOWED 39.8 MONTHS. THE PATIENT STILL FELT STIMULATION INTERMITTENTLY BUT ONLY WHEN SHE WOULD LAY DOWN. THEY NEEDED TO INCREASE IT AS HIGH AS SHE COULD GO TO FEEL THE STIMULATION. THEY HAD BEEN USING THE STIMULATION DURING THE DAY AND TURNING IT OFF AT NIGHT. GROUP IMPEDANCE WAS AT 1,064 OHMS AND THE ELECTRODE IMPEDANCE RANGE WAS 405 OHMS - ???. THE PATIENT WAS IMPLANTED FOR POST LUMBAR LAMINECTOMY SYNDROME. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698979 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 00078 YR