BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3623897 · Received February 12, 2014

    Report

    Report Number
    3004209178-2014-02851
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    January 31, 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 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED. IT WAS NOTED THAT THE PATIENT USED TO CHARGE EVERY 1.5 WEEKS OR MORE AND NOW THEY CHARGED BOUT EVERY 3 TO 4 DAYS. IT WAS NOTED THAT THE PATIENT¿S SETTING HAD NOT CHARGED SINCE THE RECHARGING ISSUE STARTED TO OCCUR WHICH WAS THE LAST MONTH OR MONTH AND A HALF. IT WAS NOTED THAT IMPEDANCES WERE ALL IN THE NORMAL RANGE AROUND 1086, 1400 OHMS. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY CHANGES IN STIMULATION DURING THIS TIME. IT WAS NOTED THAT THE PATIENT GOT REAR ENDED ON HALLOWEEN AT 60 MILES PER HOUR AND THE STIMULATION HAD NOT BEEN THE SAME SINCE. IT WAS NOTED THAT AFTER THE ACCIDENT X-RAYS WERE NEGATIVE FOR ANY LEAD ISSUES BUT THE PATIENT HAD REPROGRAMMING SESSIONS DONE TO TRY TO ADDRESS THE STIMULATION NEEDS. IT WAS NOTED THAT A RECHARGE FREQUENCY CALCULATION WAS PERFORMED BASED ON 4 PROGRAMS OF 4.5 VOLTS, 450 MICROSECONDS, 4.2 VOLTS, 450 MICROSECONDS, 2.5 VOLTS, 330 MICROSECONDS, 6.3 VOLTS, 120 MICROSECONDS, 40 HERTZ AND AN IMPEDANCE OF 986, 1042, 352, AND 749, RESPECTIVELY, WHICH WOULD GIVE THE ESTIMATED CHARGE INTERVAL OF 7.0 DAYS. IT WAS NOTED THAT BASED ON HISTORICAL RECHARGING DATA AND PROGRAMMED SETTING THE RECHARGE INTERVAL APPEARED TO BE APPROPRIATE. IT WAS NOTED THAT THE PATIENT DID HAVE A LITTLE STIMULATION ON (B)(6) 2014. ONE WEEK LATER, ADDITIONAL INFORMATION REPORTED THE PATIENT¿S NUMBER OF PROGRAMS WAS REDUCED FROM FOUR TO THREE PROGRAMS. IT WAS STATED THE REDUCTION IN PROGRAMS WAS INTENDED TO HELP WITH THE PATIENT¿S RECHARGE INTERVAL. IT WAS ONCE AGAIN NOTED THE PATIENT¿S ¿IMPEDANCES WERE WITHIN NORMAL RANGE.¿ A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93720 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