BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1231031 · Received October 30, 2008

    Report

    Report Number
    2182207-2008-07056
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FOR LEAD OR EXTENSION.

    Description of Event or Problem · 1

    IMPEDANCES GREATER THAN 40,000 OHMS WERE READ ON ALL ELECTRODES AT DEVICE IMPLANTATION. THE PATIENT FELT STIMULATION SENSATION. THE #0 ELECTRODE MAY HAVE BEEN OUT OF RANGE. DEVICE TROUBLESHOOTING INCLUDED CHANGING THE AMPLITUDE OF THE NEUROSTIMULATOR, RESEATING THE LEAD AND EXTENSIONS MULTIPLE TIMES, DRYING OFF THE CONNECTOR AND RECONFIGURING THE LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION| EXPLANTED:| LEAD: MODEL UNK| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER| IMPLANTED:| EXPLANTED: