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 03/22/2024 |
Event Type
malfunction
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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.It was reported that their trial began on 2024-mar-15.It was reported that the patient noticed bandaging partially removed and was worried enough to go into the er.At the er, they removed all bandaging and noted the leads had been "moved significantly".Patient was rebandaged in the er and advised to reach out to their doctor for instructions on how to proceed.Patient awaiting call back from doctor.
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Manufacturer Narrative
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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; implant date ; explant date brand name lead; product id neu_unknown_lead (lot: unknown); product type: 0200-lead; implant date ; explant date.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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