BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2890763 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12385
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(4) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(4) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE REPORTER STATED THAT THE DISPLAY SHOWED THE 'CALL YOUR DOCTOR' ICON AND THERE WAS A POR (POWER-ON RESET) CONDITION. IT WAS NOTED THAT THIS WAS SEEN THE DAY PRIOR TO THE REPORT. THE PATIENT WAS ABLE TO CLEAR THE POR CONDITION AND WAS ABLE TO USE STIMULATION AFTER THE POR WAS CLEARED. IT WAS REPORTED THAT THE ACTION RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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