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Updated: Nov 1, 2025
Controlling Parkinson's Disease With Adaptive Deep Brain Stimulation
Published on: July 16, 2014
Complications associated with deep brain stimulation for Parkinson's disease: a MAUDE study
Max Ward1, Mohsen Ahmed2, Christopher Markosian2
1Department of Neurological Surgery, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
Introduction:
Deep brain stimulation (DBS) is a common surgical option for the treatment of medically refractory Parkinson's disease (PD). Manufacturer and User Facility Device Experience (MAUDE), a United States Food and Drug Administration (FDA)-compiled database of adverse event reports related to medical devices, is a public resource that can provide insight into the relative frequency of complications and patient complaints.
Materials And Methods:
We accessed the MAUDE database and queried for adverse reports for deep brain stimulators implanted for PD from January 1, 2009 to December 31, 2018. Complaints were classified into device malfunction, patient non-compliance, patient complaint, surgically managed complications (i.e. complications that are corrected via surgery), and death. Patient complaints were further stratified into ineffective stimulation, shock, overstimulation, battery-related problems, or pain at the pulse generator site. Surgically managed complications were classified as intraoperative complications, impedance, migration, erosion, infection, lead fracture, and lead disconnection. Each event could receive multiple classifications and subclassifications.
Results:
A total of 4,189 adverse event reports was obtained. These encompassed 2,805 patient complaints. Within this group, 797 (28%) events were classified as ineffective stimulation. There were 1,382 surgically managed complications, 104 (8%) of which were intraoperative complications, 757 (55%) documented impedance issues, 381 (28%) infections, and 413 (30%) lead-related issues. There were 53 documented deaths.
Conclusions:
The MAUDE database has potential use as a real time monitor for elucidating the relative occurrence of complications associated with deep brain stimulation. It also allows for the analysis of device-related complications in specific patient populations. Although the database is useful in this endeavor, it requires improvements particularly in the standardization of reporting adverse events.
Insights
Adverse event reports for deep brain stimulation (DBS) in Parkinson's disease (PD) reveal frequent complications like ineffective stimulation and lead issues. The MAUDE database offers insights but needs standardized reporting for better real-time monitoring.
Area of Science:
- Neurology
- Neurosurgery
- Biomedical Engineering
Background:
- Deep brain stimulation (DBS) is a key treatment for Parkinson's disease (PD).
- The FDA's MAUDE database tracks medical device adverse events, offering insights into DBS complications.
- Analyzing these reports aids in understanding device performance and patient outcomes.
Purpose of the Study:
- To analyze adverse event reports for DBS devices used in PD patients.
- To identify and categorize complications and patient complaints from the MAUDE database.
- To assess the utility of the MAUDE database for monitoring DBS-related issues.
Main Methods:
- Retrieved adverse event reports for DBS in PD from the MAUDE database (2009-2018).
- Classified complaints into device malfunction, non-compliance, patient complaints, surgically managed complications, and death.
- Further stratified patient complaints and surgically managed complications into specific categories.
Main Results:
- Analyzed 4,189 adverse event reports, including 2,805 patient complaints.
- Ineffective stimulation (28%) and surgically managed complications (1,382 total) were common.
- Key complications included impedance issues (55%), lead problems (30%), and infections (28%); 53 deaths were reported.
Conclusions:
- The MAUDE database can serve as a real-time monitor for DBS complications in Parkinson's disease.
- Analysis reveals specific device-related issues and complications in patient populations.
- Standardization of adverse event reporting in the MAUDE database is crucial for improved data utility.
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