Model Number NEU_INS_STIMULATOR |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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Lin s., shu y., zhang c., wang l., huang., pan., ding j., sun b., li d., wu y.Gpi vs stn deep brain stimulation for isolated dystonia: a 3-year follow-up.European journal of neurology 2023 doi: 10.1111/ene.15895.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Continuation of d10: product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# serial# unknown implanted: explanted: section d information references the main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown, medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Lin s., shu y., zhang c., wang l., huang., pan., ding j., sun b., li d., wu y.Gpi vs stn deep brain stimulation for isolated dystonia: a 3-year follow-up.European journal of neurology 2023 doi: 10.1111/ene.15895.Abstract background: bilateral deep brain stimulation (dbs) surgery targeting the globus pallidus internus (gpi) or subthalamic nucleus (stn) is widely used in medication-refractory dystonia.However, evidence regarding target selection considering various symptoms remains limited.Objective: this study aimed to compare effectiveness of these two targets in patients with isolated dystonia.Methods: this retrospective study evaluated 71 consecutive patients (32 for gpi, 39 for stn) with isolated dystonia.The burke¿fahn¿marsden dystonia rating scale score and quality of life were evaluated preoperatively and at 1, 6, 12, and 36 months postoperatively.Cognition and mental status were assessed pre- and at 36 months postoperatively.Results: stn yielded effects within 1 month (65% vs 44%, p=0.0076) and was superior at 1 year (70% vs 51%, p=0.0112) and 3 years (74% vs 59%, p=0.0138).For individual symptoms, targeting stn was preferable for eye involvement (81% vs 56%, p=0.0255), whereas gpi was better for axis symptoms, especially for the trunk (82% vs 94%, p=0.015).Targeting stn was also favorable for generalized dystonia at 36-month follow-up (p = 0.04) and required less electrical energy (p<(><<)>0.0001).Disability, quality of life, and depression and anxiety measures were also improved.Neither target influenced cognition.Conclusions: we demonstrated that gpi and stn are safe and effective targets for isolated dystonia.Stn has the benefits of fast action, ocular dystonia, generalized dystonia, and low battery consumption, while gpi is better for trunk involvement.These findings may offer guidance for future dbs target selection for different types of dystonia.Reported events: 1) 1 patient in the gpi implant group experienced an infection that was resolved by surgical intervention.2) 1 patient in the stn implant group experienced an infection that was resolved by surgical intervention.3) 1 patient in the gpi implant group experienced neurostimulator movement that was resolved by surgical intervention.See attached literature article.
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Search Alerts/Recalls
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