MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Sepsis (2067); Urinary Tract Infection (2120)
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Event Date 01/01/2019 |
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.
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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 urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that patient had a urinary tract infection and the last time they had one they wound up in the hospital with sepsis.The previous uti was in 2019.Patient services asked the patient if they felt the uti's were related to the device or therapy and patient responded that their doctor felt as though the device was causing them problems.The patient reported in 2019 after the last uti the managing physician checked the device and said it was working.Patient stated it might have been functional but it was not doing what it was implanted to help with.The patient stated reason for implant was urinary urgency, incontinence, and retention.The patient tried to follow up with their managing physician but was told that they would have to start over a new patient because it had been greater than 3 years since their last appointment.The patient did not intend to keep working with that doctor and wanted a list of other doctors in the area who worked with the device.
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Manufacturer Narrative
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B2: updated to life threatening h6: imf corrected medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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