BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3795875 · Received May 7, 2014

    Report

    Report Number
    3004209178-2014-08628
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 14, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAS ADAPTIVE STIMULATION AND IT USUALLY IS AT LEVEL 3.70 IN THE UPRIGHT POSITION. LAST WEEK THE STIMULATION FELT HIGHER THAN USUAL AND WAS UNCOMFORTABLE. ON FRIDAY THE PATIENT USED HIS PATIENT PROGRAMMER (PP) TO SYNC AND HIS UPRIGHT LEVEL WAS AT 4.30 (INITIALLY SAID 4.7V THEN CHANGED TO 4.3V). THE PATIENT HAS NEVER INCREASED TO THAT LEVEL AND HAS NEVER BEEN ON A SETTING THAT HIGH IN YEARS SINCE HE HAD HIS INS AND IT SEEMED TO HIGH. THE PATIENT HAS NOT USED HIS PP IN ABOUT 7 MONTHS. ON FRIDAY THE PATIENT DECREASED HIS STIMULATION AND STOOD FOR 3 MINUTES. ON SATURDAY THE PATIENT WAS DRIVING, ON A ROAD TRIP, SITTING MOSTLY AND DID NOT NOTICE ANY ISSUE. ON SUNDAY THE PATIENT NOTICED HIGH STIMULATION IN UPRIGHT POSITION, USED PP AND FOUND HE WAS AT 4.70V. THE PATIENT DECREASED AND 2 HOURS LATER IT WAS HIGH AGAIN AND HE DECREASED THE STIMULATION. THIS HAPPENED 5 TIMES ON SUNDAY. THE PATIENT WAS USED TO HIS LEGS GOING OFF BUT THIS WAS GOING OFF AT A HIGH INTENSITY. AN INFORMATION REQUEST WAS MADE ON THE PP. THE COMPANY REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2014. THE ADAPTIVE STIMULATION WAS INCREASING AMPLITUDE INAPPROPRIATELY IN STANDING POSITION. LYING DOWN VOLTAGE WAS AT 2.8V. GOING FROM STANDING TO LYING WAS 3.8. STANDING POSITION WAS READJUSTED TO 2.8V. THE AMP WAS CHECKED FROM LYING TO STANDING POSITION, WORKED FINE FROM STANDING TO LYING IT DECREASED APPROPRIATELY. THE LIMITS WERE SET ACCORDINGLY AND SET AT FULL RANGE FOR AMPLITUDE. IT WAS ADDITIONALLY REPORTED ON (B)(6) 2014 THAT THE AMPLITUDE¿S HAVE BEEN CHANGING UNEXPECTEDLY WHEN THE PATIENT WAS IN AN UPRIGHT POSITION. THE AMPLITUDE SEEMS TO CHANGE AND INCREASE UP TO 4.7V THOUGH NO POSITIONS ARE PROGRAMMED TO 4.7V. IT WAS FURTHER REPORTED THAT WHEN THE PATIENT WAS STATIONARY, SITTING OR LYING DOWN THE UPRIGHT MOBILE WILL RAMP UP TO 4.7V. IT WAS UNKNOWN IF UPRIGHT MOBILE HAS BEEN PROGRAMMED BEFORE IN THE PAST. WHEN THE PATIENT CHECKS HIS PP, IT DOES STAY UPRIGHT MOBILE AT 4.7V. THE PRINTED REPORT ON THE AMP TREND INDICATED THE MAX AMPLITUDE FOR GROUP A1 AND ¿A1¿ WAS 4.6V AND 4.6V. UPRIGHT MOBILE HAS BEEN DEACTIVATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT LATER REPORTED THAT THE IMPEDANCES WERE GOOD AND NO MALFUNCTIONS WERE SEEN. THE DEVICE WAS REPROGRAMMED WITHOUT "UPR" AND WALKING. THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275705 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