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/bowel dysfunction and urge incontinence.It was reported that the patient thinks the ins is mostly intended to treat bladder control (patient stated they don't think their stimulator is associated with their bowels).It was reported that they have been having severe pain that has been "more or less" in their rectum since patient has had the stimulator.When agent asked for event date patient stated they have had it quite a while, "most of the summer" and stated at first it seemed to be mostly in their vaginal area but reported now it's higher.The patient was going to have an mri "defecography" of their rectum and lower bowel area.They "think" this mri is unrelated to their device, but stated they think it may give a solution to the pain patient has been having.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.The patient's relevant medical history included patient made a comment during the call that sometimes they will change programs if they have "a burning or whatever" (patient did not clarify this statement).Patient stated their "digestive person" told them that they possibly may need a "rectoseal" but patient needs the mri first.They have read that the rectoseal could create vaginal pain.Agent had a difficult time hearing patient throughout call and made best attempt to gather all relevant information.
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