BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1051760 · Received May 21, 2008

    Report

    Report Number
    2182207-2008-02715
    Event Type
    Injury
    Date Received
    May 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BLAHAK C. WOHRLE JC, CAPELLE HH, ET AL. HEALTH-RELATED QUALITY OF LIFE IN SEGMENTAL DYSTONIA IS IMPROVED BY BILATERAL PALLIDAL STIMULATION. J NEUROL 2008;255(2):178-182. IN TEN PATIENTS WITH IDIOPATHIC SEGMENTAL DYSTONIA, WE PROSPECTIVELY EVALUATED THE EFFECT OF BILATERAL GPI STIMULATION ON QUALITY OF LIFE. FOLLOW-UP WAS TO A MEAN OF 17 MONTHS POSTOPERATIVELY. REPORTABLE EVENT: IN FOUR PATIENTS STIMULATION-ASSOCIATED HYPOKINETIC DYSPHONIA IMPEDED FURTHER INCREASE OF STIMULATION INTENSITY OF GPI DBS. HOWEVER, IN ALL OF THESE PATIENTS, A SATISFYING COMPROMISE BETWEEN THE DEGREE OF DYSPHONIA AND IMPROVEMENT OF DYSTONIA COULD BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LEAD MODEL 3387 N=1| PROGRAMMER MODEL UNK N=1| IMPLANTABLE NEURO STIMULATOR| MODEL SOLETRA 7426 N=2