Abstract Details

Title Adverse Events with Implantable Deep Brain Stimulators - Trends and Insight from the FDA MAUDE Database, 2001 - 2007

Topic Movement Disorders

Presentation(s) P02 - (-)

Poster/Presentation
Number 074

Objective

Background BACKGROUND: Implantable deep brain stimulators (DBS) have been established as an effective therapy for patients with Parkinson's disease and other movement disorders. Most published data on AEs with DBS comes from small case series and clinical trials with limited ability to detect AEs. The real-world frequency and nature of AEs with DBS are unknown.

Design/Methods DESIGN/METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a publicly-available site for voluntary reporting of medical device AEs. The authors queried MAUDE and categorized AEs reported between 2001 and 2007 for the DBS devices Activa, Soletra and Kinetra (Medtronic Inc.,Minneapolis MN). Duplicate reports were discarded. Continuous variables were evaluated with the Student's t-test.

Results RESULTS: During the study period, 474 separate AEs were reported. Annual AEs increased significantly from 18 in 2001 to 184 in 2007 (p <0.03). Events were classified in the database as malfunctions (n = 135), injury (n = 146), and death (n = 37). Only 2 of 37 deaths (5%) were possibly device-related. Common AEs were related to infection/device pocket issue (n = 185, 39%), battery/electrical/device malfunction (n = 115, 24%), clinical deterioration (n = 35, 7%) and EMI (n = 32, 7%). Other serious AEs were infrequent with 13 reports ICH/stroke and 3 reports of seizure. Explantation of the DBS device was reported in 258 (54%) of AEs primarily due to infection, battery or electrical failure.

Conclusions CONCLUSIONS: The frequency of AEs with DBS devices increased dramatically between 2001 and 2007. Within the accepted limitations of a voluntary database, infection and device malfunction are common AEs and often lead to explantation. More serious events such as death or stroke are uncommon. This study includes larger numbers of AEs than prior published reports and reinforces the need for device registries for long-term safety evaluation.

Authors/Disclosures
Natalie Diaz, MD (Pacific Neuroscience Institute/Providence Little Company of Mary Med Ctr.) PRESENTER	No disclosure on file
Aaron McMurtray, MD, FAAN (Vanderbilt University Medical Center)	The institution of an immediate family member of Dr. McMurtray has received research support from US Government . An immediate family member of Dr. McMurtray has received intellectual property interests from a discovery or technology relating to health care. Dr. McMurtray has received personal compensation in the range of $100,000-$499,999 for serving as a Panel member with Legal Firm.
Kristen Johnson, PhD (Novartis)	No disclosure on file

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