BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3974070 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13862
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 10, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A, LOT # N303861, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT THE PATIENT CALLED ¿IN A PANIC¿ BECAUSE THE PATIENT WENT TO CHARGE BATTERY BECAUSE IT WAS DEAD. IT WAS STATED THAT THE DEVICE ¿CAME ON¿ AND THE PATIENT WAS TRYING TO SHUT IT OFF WITH THE RECHARGER BUT APPARENTLY IT WOULD NOT SHUT OFF. IT WAS STATED THAT THE CALLER TOLD THE PATIENT TO USE THE PATIENT PROGRAMMER AND THAT WOULDN¿T WORK EITHER. IT WAS NOTED THAT THERE WAS AN ATTEMPT TO CONFERENCE IN THE PATIENT BUT THE CALL DID NOT CONNECT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PATIENT HAD AN OVERSTIMULATION SENSATION. IT WAS STATED THAT IT WAS OCCURRING CURRENTLY AND THE CALLER NEEDED HELP WITH RESETTING. IT WAS NOTED THAT IT WAS DISCUSSED WHY IT OCCURRED AND HOW TO STOP THE STIMULATION. IT WAS STATED THAT THE CALLER HAD NOT BEEN WORKING WITH THE PATIENT EARLIER AND DECLINED TO STATE WHO WAS WORKING WITH THE PATIENT ON AN OVERDISCHARGE RECOVERY. IT WAS STATED THAT THE OVERSTIMULATION OCCURRED TODAY BUT IT WAS NOT KNOWN WHEN THE OVERDISCHARGE OCCURRED OR THE REASON THE PATIENT WENT IN TO OVERDISCHARGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY DID ANOTHER PHYSICIAN MODE RECHARGER (PMR) TOGETHER AND THE OVERSTIMULATION STOPPED. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR SHUT OFF AND THE PATIENT WAS NO LONGER FEELING STIMULATION. IT WAS STATED THAT ¿ONCE THE PATIENT CALMED DOWN¿ THEY WOULD CALL HER TO SCHEDULE A TIME TO MEET WITH HER TO CHECK THE SYSTEM AND GET THERAPY WORKING AGAIN FOR THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD INSTRUCTIONS ON HOW TO DO PMR (IT WAS NOTED THAT IT WAS UNKNOWN WHO PROVIDED THEM TO THE PATIENT). IT WAS STATED THAT THE PATIENT WENT AHEAD AND INITIATED THE PMR HERSELF, SAWPOR (POWER ON RESET) AND THEN SHE HAD OVERSTIMULATION. IT WAS STATED THAT IT WAS UNKNOWN WHAT THE PATIENT DID FROM WHEN THE POR WAS SEEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECHARGING AND SAW THE POR¿AND THEN FELT SHOCKING.¿ IT WAS STATED THAT IT PUT HER LEGS INTO SPASM. IT WAS STATED THAT THE PATIENT STATED SHE WAS GOING TO CALL 911. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS NOT SURE OF THE SEQUENCE OF EVENTS. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE LEFT A VOICEMAIL WITH THE PATIENT YESTERDAY AND WHEN THE PATIENT CALLED BACK THEY SAID THEY ALREADY TALKED TO SOMEONE AND WAS CHARGING THE BATTERY. IT WAS STATED THAT THE PATIENT THEN CALLED BACK 20 MINUTES LATER TO REPORT THAT THE SYSTEM WAS SHOCKING HER AS THE RECHARGER DISPLAYED POR. IT WAS STATED THAT THE PATIENT WAS UNABLE TO TURN STIMULATION OFF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNSURE WHEN THE OVERDISCHARGE OCCURRED; ¿MY GUESS¿ WAS ON (B)(6) 2014. IT WAS STATED THAT THE OVERDISCHARGE WAS CONFIRMED AND THE CAUSE WAS STATED TO BE THE PATIENT NOT CHARGING HER BATTERY. IT WAS STATED THAT THE PATIENT WAS EXPERIENCING NO STIMULATION. IT WAS NOTED THAT THE CODE ACCOMPANYING THE POR WAS UNKNOWN. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE SAW THE PATIENT ON (B)(6), AND THE POR WAS CLEARED WITH THE 8840 (CLINICIAN PROGRAMMER). IT WAS STATED THAT THE PATIENT WAS DOING WELL AND HAD GOOD STIMULATION COVERAGE. NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT. IT WAS NOTED THAT PATIENT¿S NAME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450880 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 00040 YR