BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1994286 · Received January 14, 2011

    Report

    Report Number
    3007566237-2011-00380
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC AND NO STIMULATION SENSATION FOLLOWING AN UNRELATED MEDICAL PROCEDURE. HE TURNED HIS DEVICE OFF PRIOR TO KNEE SCOPE SURGERY. IT REMAINED OFF FOR 24-48 HOURS. WHEN HE WENT TO TURN IT BACK ON, HE DID NOT FEEL STIMULATION. THERE HAVE BEEN NO FALLS OR TRAUMA. THE LEADS WERE IN THE CORRECT LOCATION AND ORIENTATION. HE WAS REPROGRAMMED A COUPLE WEEKS AGO AND WAS ABLE TO FEEL STIMULATION FOR ONE WEEK, BUT THEN IT STOPPED. THE PATIENT WAS AT THE CLINIC AND THE LEAD IMPEDANCE MEASUREMENTS WERE GREATER THAN 10,000 OHMS WHEN RAN NO HIGHER THAN DEFAULT. A COUPLE GOOD IMPEDANCES WERE FOUND WHICH REQUIRED HIGHER AMPLITUDE WHEN PROGRAMMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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