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.
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction (incontinence, urgency, and/or frequency).It was reported that there was an impedance issue.Exact impedance values were unknown. patient phone call after symptoms returned.Patient experienced a return of their baseline symptom incontinence (unknown if bowel or urinary).Patient tried to increase stim and the remote told them maximum settings have been reached.This happened for program 3 and 4 but were able to increase settings on program, 2 to a therapeutic level with no problems.Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the impedance issue was "there was only impedence of 4000 on c and 0 electrodes yesterday and we were able to increase stimulation on the programs per usual.Not sure if it was a device issue or a patient usage error of the remote initially." the rep indicated the likely cause of this issue was unknown.The rep indicated that the cause of the maximum settings message and not being able to increase stimulation was unknown/not determined but they indicated that the issues have been resolved.
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