BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4203357 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20439
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 27, 2014
    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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVERDISCHARGE WAS SUSPECTED. DISSATISFACTION WAS THE PRIMARY REASON FOR THE OVERDISCHARGE. THE LAST SUCCESSFUL RECHARGING SESSION WAS 6-12 MONTHS PRIOR TO THIS REPORT. 6-7 MONTHS AGO THE STIMULATION WAS NOT HELPING THEIR PAIN SO THE PATIENT STOPPED USING THE IMPLANTABLE NEUROSTIMULATOR (INS) AND RELIED ON A PUMP DEVICE. THE PATIENT THEN WANTED TO USE THE INS. THE PATIENT THEN EXPERIENCED AN OVERSTIMULATION SENSATION. THE PATIENT WAS IN THE EMERGENCY ROOM. THE DEVICE WAS NOTED TO BE ON CONSTANTLY AND THE DEVICE WOULD NOT TURN OFF. THE STIMULATOR WAS CAUSING PAIN AND ELECTRICITY INTO THE SPINE AND NERVES. THE PATIENT WAS IN PAIN AND WAS SHAKING. THE OVERSTIMULATION WAS STATED TO HAVE STARTED ON (B)(6) 2014. THE PATIENT WAS EXPERIENCING A NONSTOP SHOCKING SENSATION. THE PHYSICIAN MODE RECHARGE (PMR) HAD RECENTLY BEEN DONE. THE EXACT DATE OF THE PMR WAS NOT KNOWN DUE TO THE PATIENT EMERGENCY. THE PATIENT PROGRAMMER (PP) WAS USED TO TRY TO STOP THE OVERSTIMULATION AND ENCOUNTERED A WARNING POWER ON RESET (POR). THE RECHARGER WAS THEN USED TO COMPLETE A PHYSICIAN MODE RECHARGE TO TRY TO STOP THE OVERSTIMULATION. THE PATIENT WAS FEELING MORE SHOCKS WHEN THE RECHARGER ANTENNA WAS OVER THE IMPLANT. THE PATIENT WAS IN SO MUCH PAIN THAT SHE WOULD NOT LET THE RECHARGER ANTENNA BE PUT OVER THE DEVICE. THE DOCTOR WAS ABLE TO BE AIDED THROUGH COMPLETING A SHORT PRM WHICH WAS SUCCESSFUL AT TURNING THE INS OFF. FURTHER INFORMATION PERTAINING TO THE ORIGINAL PMR REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD BEEN ABLE TO CHARGE THROUGH THE POR AND HAD THE NORMAL RECHARGE SCREEN BUT THE PATIENT COULDN¿T STAY AND CHARGE BECAUSE ¿IF YOU WON¿T LET ME GO HOME NOW THEN I WON¿T BE ABLE TO DRIVE HOME.¿ AN APPOINTMENT BETWEEN THE PATIENT AND REPRESENTATIVE WAS MADE TO CLEAR THE POR BUT WAS CANCELLED DUE TO THE PATIENT NOT FEELING WELL. A LANGUAGE BARRIER THAT WAS BEING WORKED THROUGH WAS ALSO MENTIONED. THE PATIENT¿S HUSBAND WAS NOTED TO HAVE BEEN ¿JUST HITTING BUTTONS.¿ THE PATIENT WAS DOING FINE AS OF (B)(6) 2014 AND JUST FELT ¿NORMAL SORE.¿ THE PATIENT WAS ADVISED TO NOT TURN THE STIMULATION ON UNTIL BEING ABLE TO MEET WITH THE REPRESENTATIVE. FOLLOW-UP WAS PERFORMED TO DETERMINE IF AN OVERDISCHARGE WAS CONFIRMED, IF THE POR HAD BEEN CLEARED, IF ANY FURTHER TROUBLESHOOTING HAD OCCURRED, IF THE CAUSE OF THE EVENT HAD BEEN DETERMINED, AND IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE ON (B)(6) 2014 FROM HER HEALTHCARE PROVIDER (HCP) OR A MANUFACTURING REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. HOWEVER, SHE STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY BUT WAS WORKING WITH THEM AND HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014. AT THE APPOINTMENT IT WAS DISCOVERED THAT THE PATIENT¿S DEVICE CHARGED FROM 0 TO 75% IN A VERY SHORT PERIOD OF TIME. THEY WERE ADVISED THAT THIS WAS NORMAL FOR A DEVICE THAT HAD BEEN IN AN EXTENDED OVERDISCHARGE. IMPEDANCE TESTING WAS PERFORMED AND ELECTRODE IMPEDANCES WERE WITHIN NORMAL RANGES WITH NO REPEATING VALUES. GROUP IMPEDANCES: GROUP A: PROGRAM 1: 751 OHMS, PROGRAM 2: 306 OHMS, PROGRAM 3: 286 OHMS, PROGRAM 4: 1177 OHMS; GROUP B: PROGRAM 1: 750 OHMS, PROGRAM 2: 270 OHMS, PROGRAM 3 AND 4: GROUP C: PROGRAM 1: 627 OHMS, PROGRAM 2: 336 OHMS, PROGRAM 3: 290 OHMS, PROGRAM 4:---. GROUP IMPEDANCES APPEARED NORMAL AND IT WAS ADVISED THAT THE PATIENT WAS GOING TO NOTICE MUCH MORE FREQUENT RECHARGING THAN BEFORE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. [FALL/CHARGE MORE OFTEN ISSUE EVENT CAPTURED IN (B)(4)].

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AT THIS TIME THE PATIENT WAS GETTING ADDITIONAL TESTING DONE. THE POWER ON RESET (POR) WAS CLEARED AND THE PATIENT DID NOT HAVE A FOLLOW-UP WITH THE DOCTOR YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683178 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