BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3813446 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09044
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE RECHARGER, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE PATIENT HAD INCREASED BASELINE PAIN IN THEIR LOWER BACK. IT WAS FURTHER NOTED THAT STIMULATION WAS STILL EFFECTIVE FOR THE PATIENT¿S LEGS. IT WAS NOTED THE PATIENT HAD NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE REPORTER STATED THAT THE ONLY THING THEY COULD THINK OF AS A POSSIBILITY WAS THAT THEY STRETCHED UP ON THEIR ¿TIPPY TOES¿ HELD ON WITH THEIR LEFT HAND AND REACHED UP WITH THEIR RIGHT ARM. IT WAS NOTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED ON THEIR LEFT SIDE. IT WAS FURTHER NOTED THAT WHEN THE PATIENT CAME DOWN THEY WERE HURTING AND ACHING. THE REPORTER STATED THEY WONDERED WHY THE STIMULATION WAS NOT COVERING THAT AREA. THE REPORTER FURTHER STATED THEY THOUGH THE STIMULATION PROGRAM HAD ¿PAUSED, AND THEN THEY DID NOT GET THE SAME COVERAGE.¿ IT WAS NOTED THE PATIENT HAD BEEN HAVING ¿ISSUES¿ WITH THE INS AND IT HAD BEEN ¿ACTING UP.¿ IT WAS FURTHER NOTED THE PATIENT HAD CONTACTED THEIR HEALTHCARE PROFESSIONAL (HCP) AND A MANUFACTURING REPRESENTATIVE. THE REPORTER STATED THE INS USED TO COVER THE LOWER PART OF THEIR BACK AND THEIR LEGS, BUT THEIR LOWER BACK WAS NOT BEING COVERED ANYMORE. THE REPORTER STATED THEY CONTACTED THEIR HCP AND THEY THOUGHT THE INS BATTERY COULD BE WEAKENING. IT WAS NOTED THE INS WAS IMPLANTED 5.5 YEARS AGO. IT WAS FURTHER NOTED THE PATIENT WAS WORKING, BUT THEY HAD NOT DONE ANYTHING THAT WOULD DAMAGE THE INS. THE REPORTER STATED THAT ON 2014-(B)(6) THEY INCREASED STIMULATION AND IT HELPED A LITTLE BIT, BUT THEY SWITCHED PROGRAMS AGAIN AND IT WENT BACK TO THE LIMITED COVERAGE. THE REPORTER FURTHER STATED THE PROGRAMMER SCREEN COMES UP AS NORMAL AND THEY COULD TURN THE INS ON AND OFF. IT WAS NOTED THE PATIENT WAS ABLE TO RECHARGE AND THEY THOUGH THE INS MIGHT BE LOW. IT WAS FURTHER NOTED THERE WAS NO COMMUNICATION ISSUES, NO SHOCKING AND NO SURGING. THE REPORTER STATED THE STIMULATION IN THEIR LEGS HAD NOT CHANGED. THE REPORTER FURTHER STATED THE STIMULATION FOR THEIR FEET WAS ¿A GOOD CHARGE, IT FELT GOOD, A FULL CHARGE.¿ IT WAS NOTED THE PATIENT WAS GOING TO CONTACT THEIR HCP FOR AN APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR HCP OR A MANUFACTURING REPRESENTATIVE. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON 2014-(B)(6). ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290519 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR