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
Wound Dehiscence (1154); Unspecified Infection (1930); Cognitive Changes (2551); Confusion/ Disorientation (2553)
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Event Date 07/16/2022 |
Event Type
Injury
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Event Description
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Soler-rico, m., peeters, j., joris, v., delavalle, m., duprez, t., raftopoulos, c.Mri-guided dbs of stn under general anesthesia for parkinson¿s disease: results and microlesion effect analysis.Acta neurochirurgica 164, 2279¿2286 (2022).Https://doi.Org/10.1007/ s00701-022-05302-x summary: background the efficacy of the subthalamic nucleus (stn) stimulation for parkinson¿s disease has been widely established.The microlesion effect (mle) due to deep brain stimulation (dbs) electrode implantation has been reputed to be a good predictor for long-term efficacy of the procedure but its analysis in asleep implantation is still unclear.We thus analyzedmle rate in our strategy of targeting the stn on mri under general anesthesia and its correlation with our long-term results.Method we retrospectively analyzed 32 consecutive parkinsonian patients implanted with a dbs targeting the stn bilaterally under general anesthesia between october 2013 and december 2020.Targeting was performed after head frame and localizer placement using a stereotactic peroperative robotic 3d fluoroscopy (artis zeego, siemens) fused with preoperative ct and mri data.We collected intraoperative data, postoperative occurrence of mle, modification of unified parkinson disease rating scale item iii (updrs iii) postoperatively and at subsequent visit, as well as reduction of medication.Results the mean operative time was 223 min.No permanent complication occurred.Mle was observed in 90.7%.The mean follow-up time was 17 months.The updrs iii for the off medication/on stimulation condition improved by 64.8% from baseline.The mean dose reduction of prolopa after the surgical procedure was 31.3%.Conclusions direct targeting of stn under general anesthesia based on preoperative ct and mri data fused with a preoperative 3d fluoroscopy is safe.It allows for a high rate of postoperative mle (90.7%) and results in prolonged clinical improvement.Reported events: 1.One patient implanted with a implantable neurostimulator (ins) for parkinson's disease reported to have experienced confusion/hal lucinations.2.One patient implanted with a implantable neurostimulator (ins) for parkinson's disease reported to have experienced an infection 2 to 5 years after implantation.They were treated at a separate center.3.One patient implanted with a implantable neurostimulator (ins) for parkinson's disease reported to have experienced an infection 2 to 5 years after implantation.They had wound dehiscence at 4 months after replacement and the complete system was removed and they were treated with antibiotics.Reimplantation occurred 6 months later.
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Manufacturer Narrative
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Concomitant medical products: product id: 3389, lot#: unknown, product type: lead.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: 3389, lot#: unknown, product type: lead.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: 3389, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3389, serial/lot #: unknown, product id: neu_ins_stimulator, serial/lot #: unknown; product id: 3389, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown; product id: 3389, serial/lot #: unknown.Age: this value is the average age of the patients reported in the article as specific patients could not be identified.Gender: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: 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.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.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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