BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1203517 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06619
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE SYMPTOMS WERE NOTICED FOLLOWING A POSITION CHANGE. PALPATING THE DEVICE SYSTEM DID NOT CAUSE CHANGES IN THE STIMULATION. IMPEDANCE MEASUREMENTS WERE >3600 OHMS AND >1000 OHMS. ELECTRODES 8 THROUGH 15 WERE ALL OUT OF RANGE. TROUBLESHOOTING WAS BEING CONSIDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESSORY: MODEL 37752| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565| EXTENSION: MODEL 37081| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| PROGRAMMER: MODEL 37743