BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4826773 · Received June 9, 2015

    Report

    Report Number
    3004209178-2015-10437
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Report Date
    May 18, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37712, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT # N243742, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON, THERE WAS AN OVERSTIMULATION SENSATION. THERE WAS A FADING SENSATION, THE PATIENT THAT AN INTERMITTENCY AND CHANGES IN STIMULATION SINCE A FALL. THE STIMULATION FELT VERY STRONG SO THAT IT WOULD MAKE HER LEGS JUMP AND THE STIMULATION WOULD BECOME WEAK. IT WAS FEARED THAT THE LEADS WERE BECOMING LOOSE DUE TO HER FALL. THE CHECK OF THE STIMULATOR SYSTEM INDICATED NUMBERS OVER 10,000 BUT THE PATIENT WAS UNSURE WHAT THAT MEANT. THE STIMULATION VOLTAGE LOOKED FINE, THE CHANGE IN STIMULATION WAS (B)(6) 2015. THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THERE WAS A CALL YOUR DOCTOR ICON, AN OUT OF REGULATION (OOR) CONDITION. THE PATIENT WENT TO LIE DOWN AND WENT TO TURN THE STIMULATION OFF AND THEN SAW AN OOR MESSAGE ON THE PATIENT PROGRAMMER. AT THE TIME OF THE REPORT THE STIMULATION WAS OFF, AND THE PATIENT RESYNCHED UP WITH THE STIMULATOR AND SAW THE OOR AGAIN AND NAVIGATED OUT OF THEIR SCREEN AND THE STIMULATION WAS STILL OFF. THE STIMULATION WAS AT 50% AT THE TIME OF THE REPORT. THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTH CARE PROFESSIONAL OFFICE FOR INJECTIONS ON (B)(6) 2015. THE PATIENT FELL IN THE BEGINNING OF MAY, THOUGH THEY DID NOT FALL ON THE BATTERY, THEY FELL FORWARD. THE PATIENT HAD 12 BACK SURGERIES. THE MANUFACTURER REPRESENTATIVE SAW THE PATIENT AFTER THE FALL AND THEIR IMPEDANCES WERE FINE AND THE PATIENT WAS NOT REPROGRAMMED. IT WAS NOTED THAT THE PATIENT CAME IN ON (B)(6) 2015 WITH A CHARGED BATTERY BECAUSE THE OOR COULD BE CAUSED BY A DEPLETED BATTERY. ON (B)(6) 2015, THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AND ALL OF THE IMPEDANCES BETWEEN PAIRS WERE ALL VERY NORMAL, 500-600OHMS. THE BATTERY WAS CHARGED ON THE DAY OF THE REPORT. THE PREVIOUS PROGRAMMING WAS EFFECTIVE FOR HER SYMPTOMS. THE MANUFACTURER REPRESENTATIVE WENT AHEAD AND REPROGRAMMED THE PATIENT. THE PATIENT WAS PREVIOUSLY RUNNING TWO PROGRAMS, EACH PROGRAM HAD A BIPOLE ON EACH LEAD AND WAS RUNNING 70HZ <(>&<)> 450 USEC WITH THE PROGRAM 1 ~6.5V AND PROGRAM 2 ~4.7V. THE NEW PROGRAMMING CONSISTED OF HAVING A PATIENT USE ONE BIPOLE FOR EACH PROGRAM AND THE PATIENT WAS ENCOURAGED TO ONLY USE ONE PROGRAM AT TIME, IT APPEARED THAT THIS WAS STILL EFFECTIVE FOR THE PATIENT SYMPTOMS. THE RATE AND PULSE WIDTH WERE KEPT THE SAME. THE PATIENT WAS ABLE TO TURN STIMULATION UP TO ~10V AND STILL FELT COMFORTABLE, EFFECTIVE THERAPY. AS SOON AS THE ELECTRODES WERE CHANGED UP THE STIMULATION NORMALIZED AND THE PATIENT FELT THE STIMULATION THE SAME AS THEY HAD THE PREVIOUS FOUR YEARS. THERE WAS A LIGHT CONCERN ABOUT THE POSSIBILITY OF NEEDING A REVISION BECAUSE THE PATIENT THAT SO MANY SURGERIES WITH SO MUCH SCAR TISSUE THERE MAY BE DIFFICULTY FINDING A SURGEON TO WORK WITH THE PATIENT. IT WAS NOTED THAT IT APPEARED THAT ADJUSTING THE PROGRAMMING HAD REMEDIED THE OVERSTIMULATION, FADING, AND OOR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372115 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR