BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1193446 · Received October 7, 2008

    Report

    Report Number
    2182207-2008-06418
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 12, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN IN HIS ARMS AT EXTREMELY LOW VOLTAGE SETTINGS ON HIS DBS DEVICE. THE PATIENT USED TO GET GOOD THERAPY AT 3 VOLTS. NOW, THE PATIENT CAN NOT TOLERATE THE DEVICE BEING SET AT 0.1 VOLTS. IT WAS UNKNOWN IF THE PATIENT HAD RECENTLY SUFFERED A FALL OR TRAUMA. IMPEDANCE MEASUREMENTS HAD NOT BEEN PERFORMED. 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 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD: MODEL LEADMVD