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 gastrointestinal/pelvic floor and fecal incontinence.It was reported that since implant, they noticed that when patient increased the setting, the stimulation went down their right leg and their big toe curves in and rubs against the other toe.Patient said that they were getting blisters from the toe curling in and would like to lower the setting so that the big toe will straighten out.Patient asked for review on how to use the external device.Patient said mention that about a year and a half ago made an adjustment.Patient services reviewed therapy information and general programming guidance.With instruction patient connected to implant and decreased the setting.Patient will maintain stimulation level and will continue to monitor and track fecal control symptoms and their big toe.
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