BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2874087 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11853
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POWER ON RESET (POR). PATIENT HAD AN X-RAY ON (B)(6) 2012. PATIENT HAD CHECKED AFTER THE X-RAY AND THE DEVICE WAS FINE UNTIL THE MORNING OF THE REPORT. IT WAS ALSO NOTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THE DEVICE WAS SHOWING IT WAS POWERED OFF. PATIENT TURNED THE DEVICE BACK ON AND IT WAS WORKING CORRECTLY. NO FURTHER INFORMATION WAS REPORTED.

    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