MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_INS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Cognitive Changes (2551); Convulsion/Seizure (4406)
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Event Date 10/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Event date: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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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Rajabian a, vinke s, candelario-mckeown j, et al.Accuracy, precision, and safety of stereotactic, frame-based, intraoperative mri-guided and mri-verified deep brain stimulation in 650 consecutive procedures.J neurosurg.2022:1-10.10.3171/2022.8.Jns22968.Suboptimal lead placement is one of the most common indications for deep brain stimulation (dbs) revision procedures.Confirming lead placement in relation to the visible anatomical target with dedicated stereotactic imaging before terminating the procedure can mitigate this risk.In this study, the authors examined the accuracy, precision, and safety of intraoperative mri (imri) to both guide and verify lead placement during frame-based stereotactic surgery.A retrospective analysis of 650 consecutive dbs procedures for targeting accuracy, precision, and perioperative complications was performed.Reported events: 4 patients experienced suicidal ideation.21 patients experienced infection.10 cases resulted in device explant/revision.4 patients experienced intracranial hemorrhage.3 patients experienced seizure.16 patients experienced confusion/delirium.10 patients required revisions due to local discomfort of possible erosion.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.
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Search Alerts/Recalls
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