G2: the country of origin is canada.H3: the ins, model# b35200, serial# (b)(6), was returned for product analysis as it was replaced due to normal ins battery depletion.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Analysis determined that the ins was functional.During analysis which included visual, bench functional, and final functional testing, no audible sound or vibration was observed with the returned ins.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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.
|
Information was received from a manufacturer representative and a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's ins was at eri.Prior to the scheduled replacement, the patient experienced a strange grinding sound and vibration from the ins approximately 4 times in a row, extending over a period of 1 minute.They didn't feel any shocks or pain and therapy remained on.The replacement was on april 11, 2023 and the issue was resolved.Additional information received from a manufacturer representative.It was reported that the ins was being replaced due to normal battery depletion.
|