BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2854743 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11072
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE CALLER REPORTED THAT THERE WAS A "CALL YOUR DOCTOR" ICON AND A POWER ON RESET (POR) CONDITION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT GETTING RELIEF BECAUSE HE WAS SEEING THIS MESSAGE SCREEN AND HE WAS TRYING TO TURN HIS IMPLANT ON. IT WAS NOTED THAT THE PATIENT "WAS ABLE TO CLEAR" AND THE PATIENT WAS ASSISTED IN TURNING HIS DEVICE BACK ON. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE AS OF THE DATE OF THIS REPORT.

    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