MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Pocket Erosion (2013); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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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.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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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that its works for my bowel incontinence.But i have to test it for playing pickleball, horseback cantering, and intercourse.Those will be real test.Insurance covered all but (b)(6).The problem im having the implant works itself out over time.This is my 4th try.Additional information was received the caller reports that after the first device in 2020, they had to have additional surgeries.The device worked it's way out of the body and had to be placed deeper, it worked it's way out again and was moved to the other side of the body.It was then replaced all together in 2023.The caller also mentioned that they went horseback riding and camping this weekend and that the device still controlled their symptoms.The caller reports that the real test will be when they begin playing pickle ball again.
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Search Alerts/Recalls
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