BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1213773 · Received October 22, 2008

    Report

    Report Number
    2182207-2008-06744
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT FELL A MONTH AGO. THE PT WAS NOT FEELING STIMULATION. AN IMPEDANCE CHECK WAS DONE AT 3 VOLTS; ALL OF THE CONTACTS WERE >40,000 OHMS, GROUP IMPEDANCES WERE ALSO DONE AND ALL OF THEM WERE HIGH AS WELL. AN X-RAY WAS SUGGESTED. A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC NEUROMODULATION 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 8840| LEAD: MODEL 3778| EXPLANTED: