Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction (incontinence, urgency, and/or frequency).It was reported that patient was explanted one month after implant due to infection at lead site.And oral antibiotics was given.
|
Continuation of d10: product id 978b128 lot# (b)(6) serial# implanted: (b)(6) 2023 explanted: (b)(6) 2023 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 20-sep-2024, udi#: (b)(4) 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.
|