BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3843781 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09976
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    June 11, 2013
    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
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN A DISCHARGED STATED. IT WAS NOTED THAT THE POWER-ON-RESET (POR) HAD OCCURRED AND WAS NOT SUCCESSFULLY CLEARED. THE PATIENT WAS GOING TO RESCHEDULE AN APPOINTMENT TO CLEAR THE POR ONCE THE INS WAS CHARGED (PATIENT WAS ADVISED TO CHARGE TO 25% IN ORDER TO CLEAR THE POR). THE REPORTER STATED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT AND THEIR STATUS WAS ¿ALIVE ¿ NO INJURY¿. ADDITIONAL INFORMATION RECEIVED A DAY LATER REPORTED THAT THE PATIENT HAD BEEN UNABLE TO CHARGE THE INS, BUT THE MANUFACTURING REPRESENTATIVE ASSISTED HIM WITH RECHARGING ON THE DAY PRIOR TO THIS REPORT. THE PATIENT WAS THEN ABLE TO FULLY CHARGE THE INS. THE PATIENT REPORTED THAT AFTER THE INS WAS FULLY CHARGED ON THE DAY OF THIS REPORT, HE TRIED TO ¿GET A CONNECTION¿ WITH THE INS AND THE INS ¿JUST TURNED ON¿. IT WAS NOTED THAT STIMULATION WAS ON HIGH AND THE PATIENT COULD NOT TURN IT OFF OR TURN IT DOWN. THE PATIENT REPORTED SEEING A ¿CALL YOU DOCTOR¿ ICON AND A POR CONDITION. FURTHER INFORMATION RECEIVED ON THE SAME DATE REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION DURING THE RECHARGE SESSION. THE REPORTER STATED THAT THE PATIENT HAD PRESSED THE ¿STIMULATION ON¿ BUTTON ON THE PATIENT PROGRAMMER, WHICH CAUSED STIMULATION TO TURN ON BUT AT ¿VERY HIGH LEVELS¿ AND THE PATIENT WAS UNABLE TO TURN IT OFF. IT WAS NOTED THAT STIMULATION TURNED OFF AFTER THE PATIENT INITIATED A PHYSICIAN RECHARGE MODE. THE PATIENT WAS UNABLE TO CLEAR THE POR ON THE PATIENT PROGRAMMER. THE PATIENT STATED THAT IT HAD BEEN ¿A FEW MONTHS¿ SINCE HE HAD LAST FELT ANY STIMULATION. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE POR HAD NOT YET BEEN CLEARED AT THE TIME OF REPORT. THE PATIENT WAS GOING TO CHARGE THEIR BATTERY AND THEN NOTIFY THE MANUFACTURER¿S REPRESENTATIVE TO CLEAR THE POR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321498 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