FDA Adverse Event Injury Summary report: N

DEEP BRAIN STIMULATOR

MDR report key: 1159089 · Received September 12, 2008

Report

Report Number
2182207-2008-05650
Event Type
Injury
Date Received
September 12, 2008
Report Date
August 15, 2008
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
MHY
PMA / PMN Number
P960009
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FR
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

JOURNAL REFERENCE: LE JEUNE F, PERON J, BISEUL I, ET AL. SUBTHALAMIC NUCLEUS STIMULATION AFFECTS ORBITOFRONTAL CORTEX IN FACIAL EMOTION RECOGNITION: A PET STUDY. BRAIN. 2008; 131 (PT.6): 1599-1608. THE OBJECTIVE OF THE PRESENT STUDY WAS FIRST, TO REINFORCE OUR PREVIOUS RESULTS BY DEMONSTRATING REDUCED FEAR RECOGNITION IN OUR PARKINSON'S DISEASE PT GROUP FOLLOWING STN DBS AND, SECOND, TO CORRELATE THESE EMOTIONAL PERFORMANCES WITH GLUCOSE METABOLISM USING FDG-PET. THE FDG-PET AND RFE, RECOGNITION OF FACIAL EMOTIONS, TASKS WERE BOTH PERFORMED BY A COHORT OF 13 PARKINSON'S DISEASE PTS 3 MOS BEFORE AND 3 MOS AFTER SURGERY FOR STN DBS. AS PREDICTED, WE OBSERVED A SIGNIFICANT REDUCTION IN FEAR RECOGNITION FOLLOWING SURGERY AND OBTAINED A POSITIVE CORRELATION BETWEEN THESE NEUROPSYCHOLOGICAL RESULTS AND CHANGES IN GLUCOSE METABOLISM, ESPECIALLY IN THE RIGHT OFC, ORBITOFRONTAL CORTEX. REPORTABLE EVENT: WITH THE INTRA AND INTER-GROUP COMPARISONS, IN THE POSTOPERATIVE CONDITION, NO SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN THE NEUROPSYCHOLOGICAL BACKGROUNDS OF THE STN AND HEALTHY CONTROL GROUPS, EXCEPT FOR THE INTERFERENCE SCORE ON THE STROOP TEST, WHICH EVALUATES FRONTAL EXECUTIVE FUNCTIONS.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 Other PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2| LEAD MODEL 3389 N=2