Model Number 3058 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Retention (2119); Hematuria (2558)
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Event Date 11/07/2023 |
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 an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that on (b)(6) 2024 patient reported pain and urinary retention. a foley catheter placed and urine culture was sent.Re-presented (b)(6) for ongoing retention.It was stated that this was possibly device related to symptoms possibly not working properly. therapy suspended component and solifenacin stopped. resolved without sequelae (b)(6) 2023.
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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 an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that on 11/7/24 patient reported pain and urinary retention and hematuria. a foley catheter placed and urine culture was sent.Re-presented 11/8 for ongoing retention.It was stated that this was possibly device related to symptoms possibly not working properly. therapy suspended component and solifenacin stopped. resolved without sequelae 12-dec-2023.
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Search Alerts/Recalls
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