MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number NEU_INS_STIMULATOR |
Device Problems
High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Intracranial Hemorrhage (1891); Unspecified Infection (1930); Impaired Healing (2378); Shaking/Tremors (2515); Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/19/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event.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.
|
|
Event Description
|
Zhang y., chen l., sun b., wang x., wang j., wang j., woods j., stromberg k., shang h.2022.Quality of life and motor outcomes in p atients with parkinson¿s disease 12 months after deep brain stimulation in china.Neuromodulation 2022; -: 1¿8. the study aimed to demonstrate improvement in pd-related qol in patients undergoing dbs in a prospective, multicenter study conducted in china.To evaluate the effect of neurostimulation on the qol of patients with pd, a parkinson¿s disease questionnaire (pdq-8); unified parkinson¿s disease rating scale (updrs) i, ii, iii, and iv; and euroqol 5-dimension questionnaire (eq-5d) were administered at baseline and 12 months after dbs implantation.The mean change and percent change from baseline were reported for these clinical outcomes.Reported events: 2 patients experienced epileptic seizure.2 patients had device revision due to insufficient therapy.1 patient experienced cerebral hemorrhage.1 patient experienced device revision due to electrical impedance issue.1 patient experienced lung infection.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.
|
|
Search Alerts/Recalls
|
|
|