BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1447220 · Received August 20, 2009

    Report

    Report Number
    2182207-2009-05826
    Event Type
    Injury
    Date Received
    August 20, 2009
    Date of Event
    July 31, 2009
    Report Date
    August 12, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: WALKER HC, WATTS RL, GUTHRIE S, WANG D, GUTHRIE BL, BILATERAL EFFECTS OF UNILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION ON PARKINSON'S DISEASE AT 1 YEAR. NEUROSURG. 2009; 65(2): 302-9. SUMMARY: THIS ARTICLE PRESENTS A PROSPECTIVE STUDY THAT INVESTIGATED THE EFFECTS OF UNILATERAL STN DBS ON MOTOR FUNCTION IN 37 PTS WITH MODERATE TO ADVANCED IDIOPATHIC PARKINSON'S DISEASE. THE OBJECTIVE OF THE STUDY WAS TO QUANTIFY THE BENEFIT OF UNILATERAL DBS ON CONTRALATERAL, IPSILATERAL, AND AXIAL SYMPTOMS OF ADVANCED PARKINSON'S DISEASE. THE PT'S WERE EVALUATED "OFF" MEDICATION PREOPERATIVELY (BASELINE), AND THEN AT 3, 6, AND 12 MONTHS POSTOPERATIVELY. REPORTED EVENT: TWO PTS EXPERIENCED DELAYED TRAUMATIC SUBDURAL HEMATOMAS IN THE AMBULATORY SETTING SEVERAL WEEKS AFTER SUCCESSFUL DBS ELECTRODE IMPLANTATION. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE LITERATURE ARTICLE ATTACHED TO MFR REPORT# 2182207200905822.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

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