BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3252901 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12442
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 5, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT ADJUSTING TO THE DESIRED AMPLITUDE. IT WAS STATED THAT THE PATIENT WAS GETTING SURGES AND WAS TOLD TO DISABLE THE ADAPTIVE STIMULATION WHICH RESOLVED IT. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD SURGING WHEN SHE WENT FROM UPRIGHT TO LYING. IT WAS NOTED THAT THE ADAPTIVE STIMULATION WAS ENABLED ABOUT 1 WEEK PRIOR TO THE REPORT. THE REPORTER NOTED THAT THE INS WAS DETECTING THE APPROPRIATE POSITION, BUT IT WAS NOT ADJUSTING APPROPRIATELY. IT WAS NOTED THAT IT WAS ¿ZAPPING THE PATIENT¿ WHEN GOING FROM UPRIGHT TO LYING DOWN. IT WAS CONFIRMED THAT FROM UPRIGHT TO LYING, IT WAS AT 0S AND ALL OTHER TRANSITION SETTINGS WERE SET TO MINIMUMS AS WELL. AFTER THE ADAPTIVE STIMULATION WAS STARTED, THE PATIENT WAS ASKED TO LIE IN VARIOUS POSITIONS. INITIALLY WHEN THE PATIENT LIED DOWN TO START TESTING, SHE REPORTED THE STIMULATION WAS TOO HIGH. WHEN THE MANUFACTURING REPRESENTATIVE TURNED THE STIMULATION FOR LYING DOWN TO 0.00 FOR BOTH PROGRAMS AND STARTED THE ADAPTIVE STIMULATION, THE PATIENT FELT COMFORTABLE STIMULATION AND WAS REGISTERING AT 2.3 V (LYING) BUT SHOULD HAVE BEEN AT 0.0V. WHEN THE PATIENT WAS UPRIGHT, IT WAS DETECTING UPRIGHT BUT THE VOLTAGE WAS STAYING AT 2.3V. THE MANUFACTURING REPRESENTATIVE STARTED A NEW GROUP, REORIENTED, AND REPROGRAMMED AND THE INS APPEARED TO BE WORKING. IT WENT SUCCESSFULLY FROM UPRIGHT TO LYING ONCE AND THE AMPLITUDE CHANGED APPROPRIATELY, BUT THE SECOND TIME THAT THE PATIENT WENT FROM UPRIGHT TO LYING, SHE WAS GETTING ZAPPED AGAIN. IT WAS NOTED THIS WAS AFTER THE MANUFACTURING REPRESENTATIVE TRIED TO HAVE THE PATIENT WALK AROUND TO SEE IF THE UPRIGHT MOBILE MODE COULD BE INITIATED, WHICH WAS UNSUCCESSFUL. IT WAS FURTHER REPORTED THAT THE ISSUE WAS UNRESOLVED OF THE TIME OF THE REPORT AND THE ACCELEROMETER WAS STICKING UPRIGHT NO MATTER WHAT. IT WAS NOTED THAT THE PATIENT WAS IN MANUAL STIMULATION AND WAS DOING FINE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING WELL WITH HER STIMULATION IN MANUAL (ULTRA) MODE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED APPROXIMATELY TWO WEEKS AFTER THE LAST REPORT, WHICH INDICATED THAT THE PATIENT WAS GOING TO BE SEEN BY THEIR HEALTHCARE PROVIDER AND MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL. A WEEK LATER, IT WAS REPORTED THAT THE PATIENT¿S VISIT WAS A SUCCESS. ADAPTIVE STIMULATION WAS ENABLED AND IT APPEARED TO BE WORKING GREAT. THERE WERE NO COMPLAINTS AND THE PATIENT WAS REPROGRAMMED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351811 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 00063 YR