MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/04/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product id 978b128 lot# va2qmfx implanted: (b)(6) 2023-03-15 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: va2qmfx, ubd: 24-apr-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.
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Event Description
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Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for non-obstructive urinary retention.It was reported that there was a device site.Infection (incision, pocket, etc.).Device removal was performed.
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Event Description
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No new information for this event description.
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Manufacturer Narrative
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Product analysis #706435451:analysis information -- pli# 10 product id# 97800 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Continuation of d10: product id 978b128, lot# va2qmfx, implanted: (b)(6) 2023, product type lead.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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