MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Display or Visual Feedback Problem (1184); Unintended Collision (1429)
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Patient Problem
Incontinence (1928)
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Event Date 09/28/2021 |
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 the device is not helping their symptoms.Patient said they are still wetting their pants quite a bit.Patient had a wreck the day before the device was implanted.Patient fell and has been in the hospital and nursing home ever since.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.Patient is going to the hospital for an mri tomorrow morning and wants to know how to turn the device off.Reviewed how to put device in mri mode.When patient put the device in mri mode they saw a message that said missing implant info.
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Manufacturer Narrative
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Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.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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