Abstract Details

Title Tracking and Failure Analysis of Explanted Neuromodulation Devices

Topic Practice, Policy, and Ethics

Presentation(s) P2 - Poster Session 2 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-012

Objective The objective of this study was to measure current practice patterns for failure analysis of explanted neuromodulation devices.

Background Implantable neuromodulation device technology has rapidly advanced and is used to treat a broad spectrum of medical conditions, including pain, movement disorders, and various neuropsychiatric conditions. The FDA relies on Medical Device Reporting (MDR) reports from manufacturers, facilities, and users, as well as manufacturer analysis of returned devices, in their evaluation of safety issues. Devices explanted due to device failure, complications, or loss of treatment efficacy are not methodically analyzed, in part because there is no universal, systematic, or cohesive process for returning devices to manufacturers, who are best equipped to analyze them.

Design/Methods

We surveyed members of the North American Neuromodulation Society (NANS) regarding institutional guidelines and regulations.

Results

We received 104 analyzable responses primarily from attendings practicing in high-volume settings. Among respondents, 30% were not aware of their facilities’ policies for explanted device disposition or communication with manufacturers and the FDA, and 25% were not aware of documented policies for release of explanted devices to manufacturers. Of the respondents who were aware of their facilities’ device disposition practices, 97% responded that facilities allow for release back to manufacturers, though at least 18% must first be routed through the pathology department.

Conclusions

While responses from our sample may reflect current practices, physicians are only one part of a larger ecosystem for neuromodulation devices. We outline a roadmap for different categories of stakeholders including facilities, professional societies, device manufacturers, and regulatory agencies to take responsibility for ensuring optimal patient care, including ongoing analysis of failed devices and technology improvement.

Authors/Disclosures
Tess Veuthey, MD, PhD PRESENTER	Dr. Veuthey has nothing to disclose.
Lawrence Poree, MD, PhD	An immediate family member of Prof. Poree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Prof. Poree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Saluda Medical. Prof. Poree has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Saluda. Prof. Poree has received publishing royalties from a publication relating to health care.

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