BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4110061 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17539
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 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
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. ADAPTIVE STIMULATION WAS PROGRAMMED AND THE PATIENT HAD BEEN TRYING TO CHANGE STIMULATION AMPLITUDE. THE PATIENT TRIED TO INCREASE THEIR STIMULATION FROM 120 TO 160 AND THE CHANGE WOULD NOT ¿STICK.¿ WHEN THE PATIENT CHECKED THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PATIENT PROGRAMMER AFTER MAKING THE CHANGE, IT HAD GONE BACK TO 120. THE PATIENT WAS HAVING PAIN ISSUES AND MUSCLE SPASMS AND THEY WANTED TO TURN THEIR STIMULATION UP RATHER THAN TAKE ANY MEDICATIONS. TO ADDRESS THE MUSCLE SPASMS THAT OCCURRED WITH THEIR PAIN THE PATIENT HAD INCREASED STIMULATION TO 160 OR 170 AND THE PATIENT¿S SPASMS HAD GOTTEN BETTER SO THEY WANTED TO DECREASE STIMULATION DOWN TO 140 OR 130. THE PATIENT FOUND THAT THE CHANGE WAS NOT STAYING AND THEY WERE STILL AT 160 OR 170. RECENTLY THE PATIENT HAD DECREASED STIMULATION DOWN TO 130 WHEN THEY SAT VERY STILL, BUT THAT ONLY LASTED FOR ABOUT AN HOUR UNTIL IT HAD JUMPED BACK UP. THE NIGHT PRIOR TO THIS REPORT THE PATIENT HAD TRIED DECREASING STIMULATION FROM 140 TO 130, BUT IT WAS 140 AGAIN ON THE DAY OF THIS REPORT. WHEN THE PATIENT PROGRAMMER WAS SYNCED TO THE INS THE PATIENT WAS SHOWING MOBILE. WHEN THE PATIENT SAT DOWN THE PATIENT PROGRAMMER WAS SHOWING TRANSITION ZONE AND WHEN THE PATIENT LIED BACK THE PROGRAMMER SHOWED THE APPROPRIATE POSITION. WHEN THE PATIENT SAT BACK UPRIGHT THE PROGRAMMER DISPLAYED THE APPROPRIATE POSITION OF UPRIGHT. THE PATIENT WAS THEN ABLE TO SUCCESSFULLY DECREASE STIMULATION FROM 140 TO 130. THE PATIENT THOUGHT THAT MAYBE THEY WERE HAVING PROBLEMS WITH ADJUSTING THEIR STIMULATION BECAUSE OF A HURRICANE IN THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590627 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 00047 YR