BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3563365 · Received January 8, 2014

    Report

    Report Number
    3004209178-2014-00392
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Report Date
    December 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-56, LOT # V083355, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-56, LOT # V083355, IMPLANTED: (B)(6)2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD SEVERAL SURGERIES THIS YEAR AND WAS NOT USING STIMULATOR. SHE WENT THROUGH REHAB A COUPLE OF TIMES FOR THE DIFFERENT SURGERIES. THE PATIENT WANTED TO START USING STIMULATION AGAIN BUT WAS USING HIGH AMPLITUDES. IMPEDANCES WERE CHECKED FOR LEADS AND THE VALUES OVER 10000 OHMS WERE SEEN FOR ELECTRODES 1 AND 4. REPROGRAMMING WAS DONE AVOIDING THOSE CONTACTS AND PAINFUL AREAS WERE SUCCESSFULLY CAPTURED. THE PATIENT WAS HAPPY WITH THE STIMULATION AND FELT THAT THIS WOULD TAKE CARE OF HER PAIN. THE ISSUE WAS RESOLVED. PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13893 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