BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3160227 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10061
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-39 LOT# N294192, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37752 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF. THE PATIENT DID NOT KNOW THE EXACT TIMEFRAME, BUT IT WAS REPORTED THAT IT HAD HAPPENED EIGHT TIMES. INTERROGATION WITH THE 8840 PHYSICIAN PROGRAMMER SHOWED THAT STIMULATION HAD BEEN ON 97% OF THE TIME AND THE PATIENT HAD BEEN CHARGING HER DEVICE EVERY TWO WEEKS TO 100%. IT WAS NOTED THAT THE PATIENT WAS GETTING GOOD COVERAGE AND IMPEDANCE MEASUREMENTS WERE NORMAL. IT WAS NOTED THAT THE PATIENT HAD FALLEN TWICE, ONCE ON HER FACE AND THE OTHER TIME ON THE OPPOSITE SIDE OF HER IMPLANT, THOUGH THE STIMULATION TURNING OFF ISSUE HAD BEEN OCCURRING PRIOR TO THE FALL. IT WAS NOTED THAT WHEN CHECKING THE INS THE PATIENT PRESSED THE TOP BUTTON ON LEFT SIDE OF THE PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE SAW THE PATIENT AGAIN AND BELIEVED THE PROBLEM HAD BEEN RESOLVED. THE SYSTEM IMPEDANCES WERE WITHIN NORMAL RANGES AND THE PATIENT WAS ¿REVIVING¿ THERAPY. IT WAS BELIEVED THE PATIENT HAD INITIALLY BEEN USING THE WRONG BUTTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260737 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