Information was received from a trial patient who was using an external neurostimulator (ens) for urge incontinence.It was noted that the patients trial started on (b)(6) 2024.It was reported that patient had migration, lead moved, or wire moved.Patient had a loss of therapy.Patient also experienced pain.It was unknown if the issue was resolved.
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Continuation of d10: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2024-04-11 explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: b3: date is estimated; month and year are valid.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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