Krahulik, d., blazek, f., nevrly, m., otruba, p., hrabalek, l., kanovsky, p., valosek, j.Imaging modalities used for frameless and fiducial-less deep brain stimulation: a single centre exploratory study among parkinson¿s disease cases.Diagnostics.2022.12 (3132).Https://doi.Org/10.3390/diagnostics12123132 abstract: deep brain stimulation (dbs) is a beneficial procedure for treating idiopathic parkinson¿s disease (pd), essential tremor, and dystonia.The authors describe their set of imaging modalities used for a frameless and fiducial-less method of dbs.Ct and mri scans are obtained preoperatively, and stn parcellation is done based on diffusion tractography.During the surgery, an intraoperative cone beam computed tomography scan is obtained and merged with the preoperatively-acquired images to place electrodes using a frameless and fiducial-less system.Accuracy is evaluated prospectively.The described sequence of imaging methods shows excellent accuracy compared to the frame based techniques.Reported events: one patients had an infection postoperatively that ultimately led to the removal of the entire system.The patient then underwent reimplantation with no further complications.See attached literature article.
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A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is the online publishing date of the literature article.H3,h6) no parts have been received by the manufacturer for evaluation.H4) device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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.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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