BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3914313 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12556
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 9, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD ITS FIRST CONFIRMED OVERDISCHARGE DUE TO NOT USING STIMULATION. THE PATIENT REPORTEDLY HAD NO PAIN, SO DID NOT NEED TO USE STIM, AND HAD NOT CHARGED FOR SEVERAL MONTHS. THE PATIENT FORGOT THAT THE INS NEEDED TO BE CHARGED REGARDLESS OF USE. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED AND SUCCESSFULLY RESET THE DEVICE. THE PATIENT RECHARGED THE INS AND TURNED THE INS ON DESPITE INSTRUCTIONS TO WAIT UNTIL THE NEXT APPOINTMENT TO CHECK THE DEVICE. IT WAS REPORTED, THE PATIENT BEGAN TO FEEL SHOCKING AND JOLTING AFTER SHE TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) ON. THE SHOCKING AND JOLTING WAS REPORTEDLY FELT ON THE ¿WHOLE BODY.¿ THE PATIENT WAS UNABLE TO TURN THE INS OFF WITH THE REMOTE. A PHYSICIAN MODE RECHARGE (PMR) WAS COMPLETED SEVERAL TIMES AGAIN, AND THE SHOCKING/JOLTING STOPPED. THE DEVICE WAS REPORTEDLY OFF. IT WAS NOTED, THE PATIENT WAS GOING TO MEET WITH THE MANUFACTURER REPRESENTATIVE (REP) THURSDAY OR FRIDAY. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED, BUT WOULD BE IN THE FUTURE. THE CAUSE OF THE ISSUE WAS UNKNOWN/UNDETERMINED. THE PATIENT¿S STATUS AT THE TIME OF THE CURRENT REPORT WAS ¿UNABLE TO OBTAIN.¿ ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT WAS IN OVERDISCHARGE FOR SEVERAL MONTHS. THE OVERDISCHARGE WAS RESOLVED THROUGH THE PMR AND THE PATIENT WAS ABLE TO CHARGE NORMALLY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. THE OVERSTIMULATION OCCURRED AFTER OVERDISCHARGE RECOVERY. THE PATIENT WENT TO TRY TO TURN STIM ON WHILE AT HOME AND GOT AN OVERSTIMULATION SENSATION. THE OVERSTIMULATION FELT LIKE A SHOCKING AND JOLTING SENSATION. THE REP WENT TO MEET WITH THE PATIENT TO ADDRESS THE OVERSTIMULATION BY USING PMR. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS GOING TO SEE THE PATIENT FRIDAY. IT WAS NOTED, THE PATIENT ALLOWED THE BATTERY TO OVERDISCHARGE. THE PATIENT¿S STATUS AND IF THEY WERE RECEIVING EFFECTIVE THERAPY WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THE REP SAW THE PATIENT ON 2014 (B)(6). THE OVERDISCHARGE WAS CONFIRMED WITH CODE 0X8 ON THE CLINICIAN PROGRAMMER (8840). IMPEDANCES WERE WITHIN NORMAL LIMITS. THE REMOTE AND RECHARGER WERE FUNCTIONING FINE. THE PATIENT KNEW TO EXERCISE THE INS AND NOT TO ALLOW IT TO OVERDISCHARGE AGAIN. IT WAS NOTED THAT STIM WAS CONFIRMED TO BE CORRECT AND NOT SHOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390527 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1