MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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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
Diarrhea (1811); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Date is approximate.Month and year are confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name lead; product id neu unknown lead (lot: unknown); product type: 0200-lead.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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Event Description
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Information was received from a trial patient who was using an external neurostimulator (ens) for fecal incontinence.Their trial start date was (b)(6) 2024.It was reported that the patient was experiencing discomfort/soreness/pinching and diarrhea.It is unknown if the issue was resolved.On (b)(6) 2024, they stated they were not seeing improvements in their symptoms.They had increased their stimulation now to 3.2 and thought one of the leads moved.Patient said they will be seeing their urologist today for this.
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Search Alerts/Recalls
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