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Komiya h, kimura k, kishida h, et al.Adjustment of subthalamic deep brain stimulation parameters improves wheeze and dyspnea in parkinson's disease.Front neurol.2019;10:1317.10.3389/fneur.2019.01317.Date of event: please note that this date is based off of the date that the article was accepted for publication as the publication date and 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.If information is provided in the future, a supplemental report will be issued.
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Summary: subthalamic nucleus deep brain stimulation (stn-dbs) is an effective treatment for motor features in parkinson¿s disease (pd).The authors present the case of a (b)(6)-year-old man with a 17-year history of pd.He underwent bilateral stn-dbs at the age of (b)(6) years because of troublesome dyskinesia and wearing off.His motor features dramatically improved after the operation; however, he developed dysarthria and a refractory wheeze associated with dyspnea due to abnormal hyperadduction of the false vocal fold.By adjusting the stimulation site of stn, his severe wheeze, which was considered to be the result of the unfavorable spread of current to the corticobulbar tract, was significantly improved.This report provides concrete evidence that wheezing is caused by hyperadduction of the false vocal fold as an adverse effect of stn-dbsand can be reversed by adjusting the stimulation site for stn-dbs.Reported event: a (b)(6) year old male implanted with bilateral subthalamic nucleus deep brain stimulation (stn-dbs) for parkinson's disease developed dysarthria, spastic gait disturbance, and a severe refractory wheeze associated with dyspnea resistant to anti-asthmatic agents, which gradually deteriorated over several years.At age (b)(6), the patient was admitted to the hospital in an attempt to adjust the dbs settings.At this time, he was taking levodopa/carbidopa 200 mg/day and ropinirole 8mg/day.It was noted the patient had a history of mild asthma.Nasopharyngeal endoscopy showed hyperadduction of the vocal cords, accounting for his wheeze.The following stimulation conditions were used: voltage of 3.2v, pulse width of 90 us, and frequency of 185hz per second.The authors believed that relatively high values of these parameters were selected in the previous hospital to obtain enough dbs effects for improving dyskinesia and wearing off.Therefore, we reduced the stimulation voltage, pulse width, and/or frequency, resulting in mild attenuation of the adverse effects, but troublesome dyskinesia and wearing off reappeared.In order to confirm the precise location for the stn-dbs electrodes, a surgical planning system was employed with reference to the brain anatomic images taken by 1.5-tesla 3-dimensional spoiled gradient magnetic resonance imaging and computed tomography.The implantable neurostimulator (ins) was set as the anode and the cathode was set at contact sites #2 and #3 on admission.Because the contact site #3 on both sides was located near the internal capsules, it was considered that the excess muscle contractions caused by stimulation of the motor fibers by the extra spread current may have led to the hyperadduction of the vocal cords, dysarthria, and spastic gait disturbance.Accordingly, preserving above stimulation conditions, his dbs cathodes active at contact sites #2 and #3 were changed to be active at contact site #2, resulting in significant and immediate improvements in the severe wheeze, dyspnea, speech impairment, and walking disability.The mds-updrs part iii and part iv scores were also improved to 29 and 0, respectively.The normalization of the false vocal fold constriction was confirmed by nasopharyngeal endoscopy.His dyskinesia and wearing off were well controlled.See attached literature article.The following device information was identified in the literature article: ins model 7426 and lead model 3387.
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Updated patient information received.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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