BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3072624 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06733
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 9, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SAW THE POWER-ON-RESET (POR) MESSAGE ON HER PROGRAMMER. IT WAS STATED THAT THE PATIENT HAS NOT USED THE IMPLANTABLE NEUROSTIMULATOR (INS) "IN A WHILE", BUT THE BURNING SENSATION IN HER HEELS RETURNED AND SHE WISHED TO TURN STIMULATION BACK ON. IT WAS NOTED THAT THE PATIENT HAD BEEN CHARGING THE INS REGULARLY, BUT SHE KEPT SEEING THE POR MESSAGE. ABOUT ONE WEEK LATER IT WAS REPORTED THAT A PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION OR A "SURGING" SENSATION. IT WAS STATED THAT THE PATIENT USED THE ANTENNA LOCATE (AL) FEATURE AND THEN HAD TO STOP PART WAY THROUGH. THE PATIENT "PRESSED A SERIES OF BUTTONS ON HER RECHARGER AND THEN THE STIMULATION ON THE RECHARGER AND GOT A VERY STRONG SURGING AND HER LEGS WERE SHAKING". IT WAS REPORTED THAT THE PATIENT WAS AT A "VERY HIGH" VOLTAGE AND WAS NOT ABLE TO TURN STIMULATION OFF. IT WAS NOTED THAT THE PATIENT "ALMOST WENT TO THE EMERGENCY ROOM", BUT THEN SHE WAS ABLE TO TURN STIMULATION DOWN AND OFF. ONE DAY LATER IT WAS REPORTED THAT THE PATIENT WAS SEEING THE "CALL YOUR DOCTOR" ICON IN HER PROGRAMMER AS WELL AS THE POR MESSAGE. THE POR NEEDED TO BE CLEARED WITH THE CLINICIAN PROGRAMMER. IT WAS NOTED THAT THE PROGRAMMER WAS NOT TURNING ON. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION ON (B)(6) 2013 AND WAS AFRAID TO TURN THE STIMULATION ON. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD A PROBLEM WITH GETTING GOOD COUPLING BETWEEN THE INS AND THE RECHARGER. THE PATIENT RE-POSITIONED THE ANTENNA AND PRESSED THE "START CHARGE" BUTTON AND WAS ABLE TO GET 6 COUPLING BARS AND STARTED RECHARGING. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FOUND IT WAS REPORTED THE PATIENT¿S BATTERY WAS DISCHARGED. IT WAS NOTED THE DEVICE ¿SLOWLY TURNED OFF.¿ IT WAS FURTHER STATED THE PATIENT¿S BACK ¿HAD BEEN KILLING HER,¿ BUT WAS AFRAID TO TURN THE DEVICE BACK ON. IT WAS STATED ON (B)(6) 2013 THE PATIENT HAD 2 OF THE LITTLE BOXES FILLED. IT WAS STATED, THE PATIENT WAS IN ¿SO MUCH PAIN¿ AND HAD ¿MAJOR BACK PAIN.¿ IT WAS REPORTED PATIENT WAS ABLE TO TURN ON STIMULATION AND ADJUST USING THE PATIENT PROGRAMMER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCES A SHOCKING OR JOLTING SENSATION DOWN HER LEGS WHEN THE STIMULATION WAS TURNED ON. IT WAS STATED THAT THERE WAS ANOTHER POWER-ON-RESET (POR) CONDITION THAT WAS CLEARED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174223 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