BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3441160 · Received October 31, 2013

    Report

    Report Number
    3004209178-2013-20004
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 14, 2013
    Report Date
    October 14, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: UNKNOWN LEAD, LOT AND SERIAL NUMBER: UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET (POR) OCCURRED. THE PATIENT REPORTED THAT THE POR WAS ON THE PROGRAMMER AND THE RECHARGER. THE STIMULATOR WAS 50% FULL. THE PATIENT CHARGED FULLY AND WAS NO LONGER SEEING THE POR. THE PATIENT WAS THEN ABLE TO TURN STIMULATION ON. IT WAS UNCLEAR HOW THE POR WAS CLEARED, AS A COMPANY REPRESENTATIVE DID NOT HELP THE PATIENT CLEAR IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561116 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 00051 YR