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
Itching Sensation (1943); Pain (1994); Urinary Retention (2119)
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Event Date 03/20/2024 |
Event Type
Injury
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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 urgency frequency.It was noted that the patients trial started on (b)(6) 2024.It was reported that the patient was itching on their back at the site, patient feels it will blister later.Additional information was received on 2024-mar-22, patient stated they are very itchy.Patient mentioned they were going to see their doctor for this.Additional information was received on 2024-mar-25, patient was not able to talk at this time.Pt stated they were having problems with emptying out and has a call to their sales representative in regards to this.Patient stated it hurts and is just not able to empty.Patient advised to contact their clinician with concerns.
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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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