BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1161213 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05751
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: MERELLO M, TENCA E, LLORET SP, ET AL. PROSPECTIVE RANDOMIZED 1-YEAR FOLLOW-UP COMPARISON OF BILATERAL SUBTHALAMOTOMY VERSUS BILATERAL SUBTHALAMIC STIMULATION AND THE COMBINATION OF BOTH IN PARKINSON'S DISEASE PTS: A PILOT STUDY. BR J NEUROSURG. 2008;22(3):415-422. IT HAS BEEN SUGGESTED THAT POTENTIAL RISK OF HEMIBALLISMUS AFTER SUBTHALAMOTOMY MAKES DBS PREFERABLE TO ABLATION FOR IPD TREATMENT; HOWEVER, COST AND THE NEED FOR REGULAR ELECTRODE CONTROL HAVE ALSO BEEN OBSERVED AS DISADVANTAGES TO STIMULATION. THE OBJECTIVE WAS TO COMPARE EFFICACY AND SAFETY OF DIFFERENT SURGICAL APPROACHES TO STN, IN A PROSPECTIVE RANDOMIZED PILOT STUDY. THE 16 CONSECUTIVE IPD PTS RANDOMIZED TO RECEIVE EITHER: BILATERAL STN-DBS (BS GROUP), BILATERAL SUBTHALAMOTOMY (BL GROUP), OR UNILATERAL SUBTHALAMOTOMY PLUS CONTRALATERAL STN-DBS IMPLANTATION (L/S GROUP), AND FOLLOWED FOR 12 MONTHS AFTER SURGERY. REPORTABLE EVENT: TWO PTS FROM THE BS GROUP IN WHOM MORE DORSAL CONTACTS HAD BEEN ACTIVATED, PRESENTED A CLINICAL CONDITION DURING INITIAL PROGRAMMING STAGES CHARACTERIZED BY IRRITABILITY, EXCITATION, PARANOIA AND SEVERE INSOMNIA PROGRESSING IN HOURS, AND REVERTING COMPLETELY AFTER CHANGING STIMULATION PARAMETER SETTINGS. SEE MFG REPORT 2182207200805745.

    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 Other IPG MODEL 7426 N=1| LEAD MODEL 3389 N=2| PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2