BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5160276 · Received October 20, 2015

    Report

    Report Number
    3004209178-2015-20958
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Report Date
    September 6, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4)

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED DISCOMFORT AND HEATING AT THE IMPLANT SITE WHICH STARTED A NUMBER OF YEARS AGO. THE ISSUE HAS BEEN STEADY AND IT DID NOT APPEAR TO HAVE A PATTERN OF WHEN IT OCCURRED. THE PROBLEM DID NOT OCCUR WHEN THE PATIENT WAS IN A SPECIFIC POSITION OR WHEN RECHARGING. PALPATING THE INS DID NOT HAVE AN EFFECT ON HOW THE HEATING FELT. THE IMPEDANCE MEASUREMENTS WITH REFERENCE ELECTRODE 0 WERE WITHIN NORMAL RANGE. ADDITIONAL IMPEDANCE MEASUREMENTS WERE DONE WITH ELECTRODE REFERENCE 2,8, 9, 14, 10, 15 WHICH WERE ALSO IN NORMAL RANGE. THE PATIENT WAS PROGRAMMED ON GROUP E 666, 3.301MA, 10- 11- 12+. THE COMPANY REPRESENTATIVE LATER REPORTED ON (B)(6) 2013 THAT NO TESTING WAS SCHEDULED. THE PATIENT WAS NOT CONCERNED ABOUT THE HEATING SENSATION AS IT WAS VERY SLIGHT. THIS ISSUE HAS NOT INTERFERED WITH THE NORMAL STIMULATION THE PATIENT RECEIVES. THE PATIENT WAS HAPPY WITH THE STIMULATION. THE INDICATION FOR USE WAS FAILED BACK SURGERY SYNDROME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691964 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 00061 YR