MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE Caitlin Carlton, Colby Souders, Nathan Chertack, Ramy Goueli, Gary Lemack, Jennifer Anger, Lynn McClelland, and Maude Carmel Caitlin CarltonCaitlin Carlton More articles by this author , Colby SoudersColby Souders More articles by this author , Nathan ChertackNathan Chertack More articles by this author , Ramy GoueliRamy Goueli More articles by this author , Gary LemackGary Lemack More articles by this author , Jennifer AngerJennifer Anger More articles by this author , Lynn McClellandLynn McClelland More articles by this author , and Maude CarmelMaude Carmel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Over 350,000 sacral neuromodulation (SNM) devices have been implanted since approval by the FDA in 1998 (Medtronic, 2022). SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. Here, we provide an updated on real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for “Interstim”. A random sample of 1,000 reports was reviewed and categorized by theme. To corroborate this analysis, a legal librarian searched the Public Access to Court Electronic Records database, as well as Bloomberg Law’s dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44,122 SNM-related AEs. Figure 1 illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient’s need for assistance with device use followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only 4 lawsuits: patient complications after off-label SNM device use, transverse myelitis after implant, device migration or poor placement, and a claim of device malfunction requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety and very low complication rates of SNM devices, as seen in clinical trials. We found that 43.3% of SNM “complications” are not AEs, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient. Similarly, the number of lawsuits is shockingly low for a device that has been on the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection—including at least one case in which SNM was used for a non-FDA approved indication—lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e513 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Caitlin Carlton More articles by this author Colby Souders More articles by this author Nathan Chertack More articles by this author Ramy Goueli More articles by this author Gary Lemack More articles by this author Jennifer Anger More articles by this author Lynn McClelland More articles by this author Maude Carmel More articles by this author Expand All Advertisement PDF downloadLoading ...