{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:53:15Z","timestamp":1786978395595,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T00:00:00Z","timestamp":1690416000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Over 350\u2009000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real\u2010world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation\u2010setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>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\u201012\/31\/10) and keyword (1\/1\/11\u20109\/30\/21) searches for \u201cInterstim.\u201d A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Our search of the MAUDE database returned 44\u2009122 SNM\u2010related adverse events (AEs). The figure 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\u2010shock pain, 30% of lead\/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off\u2010label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This review confirms the real\u2010world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%\u201346.3%) of SNM \u201ccomplications\u201d are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection\u2014including at least one case in which SNM was used for a non\u2010FDA approved indication\u2014lack of appropriate follow\u2010up, and\/or provider inability to assist the patient with utilizing the device after implantation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/nau.25248","type":"journal-article","created":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T07:14:50Z","timestamp":1690442090000},"page":"1655-1667","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database"],"prefix":"10.1002","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6345-2974","authenticated-orcid":false,"given":"Caitlin E.","family":"Carlton","sequence":"first","affiliation":[{"name":"Department of Urology University of Texas Southwestern Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colby P.","family":"Souders","sequence":"additional","affiliation":[{"name":"Department of Urology University of Kansas Kansas City Kansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan A.","family":"Chertack","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas Southwestern Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramy S.","family":"Goueli","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas Southwestern Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary E.","family":"Lemack","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas Southwestern Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7688-4688","authenticated-orcid":false,"given":"Jennifer T.","family":"Anger","sequence":"additional","affiliation":[{"name":"Department of Urology University of California San Diego San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"McClelland","sequence":"additional","affiliation":[{"name":"School of Law University of California Los Angeles Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1495-0448","authenticated-orcid":false,"given":"Maude E.","family":"Carmel","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas Southwestern Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,7,27]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"U.S. Food and Drug Administration. Summary of Safety and Effectiveness: Medtronic Interstim System for Urinary Control. Premarket Approval Database.1999.https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf\/P970004S004b.pdf"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.5489\/cuaj.6499"},{"key":"e_1_2_12_4_1","unstructured":"Medtronic. Interstim Therapy: Interstim Model 3023 Neurostimulator.2006.https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf8\/P080025c.pdf"},{"key":"e_1_2_12_5_1","unstructured":"Medtronic. Sacral Neuromodulation Therapy: Interstim II Model 3058 Neurostimulator.2020.https:\/\/manuals.medtronic.com\/content\/dam\/emanuals\/neuro\/MA12231A_b_052_view.pdf"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2008.01.076"},{"key":"e_1_2_12_7_1","unstructured":"BroderickJM. FDA expands MRI labeling for Interstim SNM bladder and bowel control devices.Urology Times. February 18 2021.https:\/\/www.urologytimes.com\/view\/fda-expands-mri-labeling-for-interstim-snm-bladder-and-bowl-control-devices"},{"key":"e_1_2_12_8_1","unstructured":"Business Wire. Axonics Receives FDA Approval for Third\u2010Generation Implantable Neurostimulator.Berkshire Hathaway. February 16 2021.https:\/\/www.businesswire.com\/news\/home\/20210216005268\/en\/"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000309"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000002239"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/DCR.0000000000000397"},{"key":"e_1_2_12_12_1","unstructured":"Medtronic. Sacral Neuromodulation.https:\/\/www.medtronic.com\/us-en\/healthcare-professionals\/therapies-procedures\/urology\/sacral-neuromodulation.html"},{"key":"e_1_2_12_13_1","unstructured":"Medtronic. Medtronic Interstim Systems: Information for prescribers.2020.https:\/\/manuals.medtronic.com\/content\/dam\/emanuals\/neuro\/M978286A_a_001_view.pdf"},{"key":"e_1_2_12_14_1","unstructured":"U.S. Food and Drug Administration. MAUDE \u2010 Manufacturer and User Facility Device Experience.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/SPV.0000000000000433"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1089\/end.2018.0802"},{"key":"e_1_2_12_17_1","unstructured":"HowtonL 01 10 00143 CV (Tex App. 2011).https:\/\/law.justia.com\/cases\/texas\/first-court-of-appeals\/2011\/88891.html"},{"key":"e_1_2_12_18_1","unstructured":"Greenberg Traurig Secures a Defense Verdict for Medtronic Inc.PRS Newswire. June 7 2011.https:\/\/www.prnewswire.com\/news-releases\/greenberg-traurig-secures-a-defense-verdict-for-medtronic-inc-123395723.html"},{"key":"e_1_2_12_19_1","unstructured":"LowR. Girl mother suing Children's Hospital doctor for allegedly not treating infections properly.Fox31 Denver. April 18 2019.https:\/\/kdvr.com\/news\/problem-solvers\/girl-mother-suing-childrens-hospital-doctor-for-allegedly-not-treating-infections-properly\/"},{"key":"e_1_2_12_20_1","unstructured":"RomanowskyvAdvanced Urologic Care Assocs. et al. No. 2\u2010411\u201017. N.J. Super. Ct. Law Div.2017."},{"key":"e_1_2_12_21_1","unstructured":"Medical Devices Litigation Reporter. Fed. Judge Remands Nerve Stimulator Design Defect Suit to Texas Court; 12(8) 2005."},{"key":"e_1_2_12_22_1","unstructured":"Medical Devices Litigation Reporter. Plaintiff Wins Remand of Nerve Stimulator Suit Against Medtronic; 11(25) 2005."},{"key":"e_1_2_12_23_1","doi-asserted-by":"crossref","unstructured":"Chartier\u2010KastlerE NormandLL RuffionA et al. Sacral neuromodulation with the InterstimInterstim system for overactive bladder: 3\u2010year results from the French prospective multicenter observational SOUNDS study.Eur Urol Focus. Published online July 30 2021.doi:10.1016\/j.euf.2021.06.013","DOI":"10.1016\/j.euf.2021.06.013"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23076"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.14617"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22618"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/bju.12571"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.24583"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11701-018-00905-y"}],"container-title":["Neurourology and Urodynamics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.25248","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T05:14:07Z","timestamp":1703654047000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/nau.25248"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,7,27]]},"references-count":28,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1002\/nau.25248"],"URL":"https:\/\/doi.org\/10.1002\/nau.25248","archive":["Portico"],"relation":{},"ISSN":["0733-2467","1520-6777"],"issn-type":[{"value":"0733-2467","type":"print"},{"value":"1520-6777","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,7,27]]},"assertion":[{"value":"2023-03-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-07-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-07-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}