BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2652837 · Received July 12, 2012

    Report

    Report Number
    3004209178-2012-05488
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Report Date
    June 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3708140, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3587A25, LOT#: N231018, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST HER STIMULATION. IT WAS ALSO REPORTED THAT THE PATIENT¿S PROGRAMMER INDICATED BOTH "CALL YOUR DOCTOR" AND "OOR" (OUT OF REGULATION) ICONS THE SAME MORNING AFTER AWAKING. PATIENT WAS ADVISED TO MOVE THE NAVIGATOR KEY TO THE RIGHT, AND SHE WAS ABLE TO SEE A DIFFERENT MESSAGE, BUT WAS UNABLE TO CLEARLY SPECIFY THE EXACT MESSAGE SCREEN. THE PATIENT WAS ABLE TO TURN HER STIMULATION ON AND OFF WITH THE USE OF THE RECHARGING DEVICE. PATIENT WAS ADVISED TO REPOSITION THE PROGRAMMER/ANTENNA OVER THE LOCATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS), WHICH THEN RESOLVED THE REPORTED ISSUE. IT WAS NOTED THAT THE PATIENT SAW THE SAME MESSAGE A FEW MONTHS AGO AS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE 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