BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4214090 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20664
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-0124-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37092, LOT# 253500001, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 39565-65, SERIAL# (B)(4)IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NOT BEEN SEEN. THE PATIENT WAS STILL HAVING INCREASED STIMULATION ISSUES, BUT NOT AS BAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. ON (B)(6) 2014 HE WAS IN THE MIDDLE OF A TRICKLE CHARGE AND IT ¿TOOK OFF WIDE OPEN¿ FOR 47 MINUTES BEFORE IT COULD BE CLEARED AND SHUT OFF. THE PATIENT WAS LOOKING FOR A HEALTHCARE PROVIDER (HCP) TO EXPLANT HIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES. IT WAS REPORTED AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. IT WAS REPORTED THE PATIENT HAD SEEN A POOR COMMUNICATION SCREEN ON THEIR RECHARGER (INSR) AND PROGRAMMER (PP). IT WAS REPORTED THE PATIENT HAD LAST CHARGED ABOUT A MONTH PRIOR TO (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NOT FELT STIMULATION OR CHARGED HIS STIMULATOR FOR OVER A YEAR. THE INS HAD BEEN IN OVERDISCHARGE FOR 1.5 YEARS. THE REP RECEIVED A CALL THE DAY OF THIS REPORT FROM THE PHYSICIAN¿S OFFICE AND A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED ON (B)(6) 2014 IN THE PATIENT¿S HOME. LATE THAT EVENING, THE PATIENT EXPERIENCED INCREASED STIM, AN OVERSTIMULATION SENSATION AND WAS REPORTEDLY CURRENTLY ¿IN OVERSTIMULA TION.¿ THE PATIENT CALLED THE REP IN A PANIC AND HAD CALLED THE AMBULANCE. THE PATIENT AND MEDICAL PERSONNEL PRESENT WERE UNABLE TO TURN STIMULATION DOWN OR OFF. THE PATIENT PROGRAMMER (PP) COULDN¿T TURN THE STIMULATION OFF. AFTER 45 MINUTES, THE RECHARGER FINALLY CONNECTED WITH THE BATTERY AND THE PATIENT¿S WIFE WAS ABLE TO TURN STIMULATION OFF. THE PATIENT WAS IN OVERSTIMULATION FOR ABOUT 45 MINUTES. THE PATIENT MET A REP IN THE OFFICE THE FOLLOWING DAY AND THE POWER ON RESET (POR) MESSAGE WAS CLEARED. THE PATIENT CHARGED UP TO 25% AND WAS TOLD TO CONTINUE CHARGING. THE PATIENT WAS SEEN IN THE OFFICE BY A REP ON FRIDAY (B)(6) 2014 FOR A REPROGRAMMING SESSION. THE PATIENT HAD BEEN CHARGING HIS STIMULATOR CONTINUOUSLY AT HOME BUT WAS UNABLE TO RECHARGE TO 100%. THE BATTERY FULL ICON HAD NOT YET APPEARED. THE PATIENT WAS REPROGRAMMED AND COVERAGE WAS GOOD. WHEN THE PATIENT WAS SITTING, THE PATIENT WAS GETTING GREAT STIMULATION AND COVERAGE. WHEN THE PATIENT STOOD UP OR MOVED AROUND, THE PATIENT FELT A STIMULATION SPIKE/A RISE IN STIM AND THEN STIMULATION STOPPED/WENT TO A FEELING OF NO STIM. THE PATIENT DESCRIBED THIS AS A ¿WAVE.¿ THE ¿WAVE¿ FELT LIKE 0 VOLTS TO 10 VOLTS ONLY WHEN HE WAS STANDING OR MOVING AROUND. THE ¿WAVE¿ FELT STRONGER ON THE RIGHT THAN THE LEFT. THE PATIENT FELT THE ¿WAVE¿ AS HIS NORMAL PARESTHESIA COVERAGE BUT STRONGER STIMULATION. THE PATIENT DID NOT FEEL THE ¿WAVE¿ ¿PRIOR TO STOP USING HIS STIMULATION.¿ BEFORE THE OVERDISCHARGE, HE WAS ABLE TO CONTROL HIS RATE SETTING. NO CYCLING WAS PROGRAMMED AND SOFT START/STOP WAS PROGRAMMED AT 4S. THE PATIENT WAS PROGRAMMED LEFT: 2.1 VOLTS USING ELECTRODE 3+41 AND RIGHT 2.6 VOLTS. GROUP IMPEDANCE TESTING WAS PERFORMED WHILE THE PATIENT WAS STANDING AND THE LEFT WAS 1365 OHMS AND THE RIGHT WAS 709 OHMS. THE REP HAD REPROGRAMMED THE ELECTRODES AND STARTED AT 0 VOLTS AND GRADUALLY INCREASED TO 2.2 VOLTS. THE PATIENT FELT APPROPRIATE STIMULATION COVERAGE AND THEN THE ¿WAVE¿ KICKED IN. THE REP TRIED PROGRAMMING A DIFFERENT RATE SETTING AT 20, 40, 60, 80, AND 100 BUT THE PATIENT REPORTED NO CHANGE AND CONTINUED TO FEEL THE ¿WAVE.¿ IMPEDANCE TESTING WAS PERFORMED WHILE SITTING AND WAS NORMAL. AFTER REPROGRAMMING, THE PATIENT REPORTED THE INTENSITY OF THE STIMULATION WAS NOT AS STRONG. AFTER DELETING THE PROGRAM AND REPROGR AMMING THE SAME SETTING, THE PATIENT INDICATED IT WAS NOT AS INTENSE. SINCE THE OVERSTIMULATION EPISODE, THE PATIENT HAD BEEN HAVING A HEADACHE. IT WAS REPORTED THE INS BATTERY HAD BEEN COMPROMISED DUE TO OVERDISCHARGE. AFTER TROUBLESHOOTING, IT WAS DETERMINED THAT THE PATIENT WOULD ONLY USE STIMULATION WHILE SITTING OR LYING AND WOULD BE SEEN IN A FEW WEEKS IN THE OFFICE FOR A CHECK. THE DEVICE WAS TURNED OFF AND THE AMPLITUDE WAS TAKEN DOWN TO ZERO AND THE PATIENT WAS TOLD TO CONTINUE TO CHARGE. THE PATIENT CONTINUED CHARGING AND CALLED AT 8PM THAT EVENING AND STATED HE HAD CONTINUED CHARGING BUT HAD NOT TURNED STIMULATION ON AT ALL. UPON LEAVING THE OFFICE, HE WAS DEFINITELY STILL FEELING STIMULATION WAS ON, BUT THE INS WAS PROGRAMMED TO 0 VOLTS. THE PATIENT WAS CONCERNED INCREASED STIMULATION WOULD OCCUR AGAIN. AN INS ¿SHUT OFF¿ WAS PERFORMED BUT THE PATIENT STILL FELT STIM. THE STIMULATION REPORTEDLY TURNED OFF AT 4AM. THE PATIENT DECIDED TO TAKE A BREAK FROM RECHARGING BUT WOULD CONTINUE TO RECHARGE TOMORROW, (B)(6) 2014. THE PATIENT STILL FELT THAT STIM WAS OCCURRING EVEN THOUGH THE DEVICE WAS TURNED OFF AND HAD YET TO GET HIS BATTERY FULLY CHARGED. THE PATIENT WAS GOING TO BE SEEN IN THE OFFICE IN A FEW WEEKS FROM (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695533 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 00049 YR