MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 353101 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Flatus (1865); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id: neu_unknown_lead, lot#: unknown, implanted: (b)(6) 2023, product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.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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Event Description
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Information was received from a trial patient who was using an external neurostimulator (ens) for fecal incontinence.It was noted that the patient's trial started on (b)(6) 2023.It was reported that the patient experienced gas/flatus.Additional information was received on 2023-sep-01, the patient stated they had a loose wire.Additional information was received on 2023-sep-01, patient stated they were experiencing gas but it has no odor to it.
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Manufacturer Narrative
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Continuation of d10: product id 978b1 lot# va2s1ky: product type lead 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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Event Description
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Additional information was received from a healthcare professional (hcp).The hcp reported that the cause of the loose wires was unknown.There was no indication of a loose wire.No steps were taken.Patient receiving without any problems.The issue was resolved.
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Search Alerts/Recalls
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