BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2928435 · Received January 24, 2013

    Report

    Report Number
    3004209178-2013-00927
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Report Date
    January 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT # 254990002, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 355031, LOT # N269260, IMPLANTED: (B)(6) 2010, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 355031, LOT # N226893, IMPLANTED: (B)(6) 2010, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 355028, LOT # N242860, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WHILE SITTING. THE PATIENT ONLY FELT STIMULATION WHEN HE WAS LYING DOWN. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS REPORTED THAT THIS HAD OCCURRED GRADUALLY OVER THE PAST 13-14 MONTHS. THE PATIENT HAS HAD "SOME" FALLS, BUT THEY WERE "NOT MAJOR." IT WAS STATED THAT THE HEALTH CARE PROVIDER CHECKED THE SYSTEM AND WANTED THE PATIENT TO MEET WITH A COMPANY REPRESENTATIVE. IT WAS STATED THAT X-RAYS WERE TAKEN ABOUT 3 MONTHS AGO. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS GOING MEET WITH A COMPANY REPRESENTATIVE ON (B)(6) 2012 TO EVALUATE THE SYSTEM. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH A COMPANY REPRESENTATIVE THE PREVIOUS WEEK. IMPEDANCE TESTING REVEALED THAT ALL IMPEDANCES WERE "WITHIN NORMAL LIMITS". THE PATIENT'S ELECTRODE SETTINGS WERE RE-PROGRAMMED AND THE PATIENT WAS "VERY PLEASED WITH THE OUTCOME". NO OTHER COMPLAINTS OR ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34408 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