MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 353101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Pain (1994); Discomfort (2330); Malaise (2359); Sleep Dysfunction (2517); Insufficient Information (4580)
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Event Date 04/02/2024 |
Event Type
Injury
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Manufacturer Narrative
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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 patients trial started on (b)(6) 2024.It was reported that the patient experienced pain, discomfort, out of it, not feeling well, and can't sleep.The patient also was hospitalized, discharged and had potential nerve damage.Additional information was received on 2024-apr-05, patient reported pain and in the emergency room to have their device removed on (b)(6).
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