BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4222614 · Received November 4, 2014

    Report

    Report Number
    3004209178-2014-20883
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 15, 2014
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL # (B)(4) IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES OF GREATER THAN 10,000 OHMS. ELECTRODES 12, 13, 14, AND 15 ALL READ HIGH IN COMBINATIONS WITH ALL ELECTRODES 0 THROUGH 15. IMPEDANCE TESTING WAS DONE AND THE PATIENT WAS REPROGRAMMED AS A RESULT OF THE EVENT. STIMULATION WAS REPROGRAMMED BY ELIMINATING ELECTRODE 12 FROM USE. THE PATIENT REPORTED NO LOSS OF COVERAGE WITH ELIMINATION OF ELECTRODE 12. IF THERE WAS A PRODUCT ISSUE, IT WAS NOT RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT, AND THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY. THE PATIENT REPORTED HE WAS DOING WELL AT THE TIME OF THE REPORT AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705797 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