BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1003503 · Received February 21, 2008

    Report

    Report Number
    9614453-2008-00809
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    August 1, 2007
    Report Date
    January 24, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THIS TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PRODUCT WAS RETURNED TO THE MFR FOR SUDDEN LOSS OF STIMULATION IN AUGUST 2007. THE PT FELT A "SURGE" FOR 15 MINS FOLLOWED BY COMPLETE CESSATION OF STIMULATION. THE DEVICE COULD NOT BE REACTIVATED DUE TO BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC SWISS MANUFACTURING FACILITY 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK