BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1172904 · Received September 19, 2008

    Report

    Report Number
    3004209178-2008-05972
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNABLE TO ADJUST STIMULATION. THE SELF-LAST BEEP WAS NOT HEARD. IT WAS REPORTED THAT "ALL FOUR LIGHTS ARE LIT." USING A DIFFERENT PROGRAMMER, THE PT WAS UNABLE TO ADJUST STIMULATION. THE GREEN BATTERY STATUS LIGHT OF THE DEEP BRAIN STIMULATION WAS NOT LIT. THE PT HAD AN APPOINTMENT WITH HIS HCP. NO PT SYMPTOMS WERE REPORTED. DEVICE REGISTRATION SYSTEM INDICATES THAT THE DEEP BRAIN STIMULATION WAS REPLACED APPROXIMATELY 2 WEEKS LATER. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR EXTENSION: MODEL 7482| PROGRAMMER: MODEL PROGRAMMER| LEAD: MODEL 3387| EXPLANTED:| EXPLANTED: