MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 353101 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id.Product type lead section d information references the main component of the system.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 urge incontinence and urgency frequency.It was noted that the patient's trial started on (b)(6) 2024.It was reported that the patient was experiencing a migration, lead moved, or wire moved.Issue was not resolved and is ongoing.
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Manufacturer Narrative
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Continuation of d10: product id neu_unknown_lead, product type 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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