BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1083510 · Received July 29, 2008

    Report

    Report Number
    9614453-2008-04466
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS IMPLANTED FOR TWO YEARS AND USED 3-4 VOLTS. THE NEUROSTIMULATOR UNEXPECTEDLY STOPPED WORKING. NO PT INJURY WAS REPORTED. REFER TO MFR REPORT # 9614453200804464.

    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 50 YR Required Intervention LOT# NFW621451S IMPLANTED| IMPLANTABLE NEURO STIUMLATOR MODEL 7426| EXPLANTED