MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name interstim; product id 3889-28 (lot: va1xhuf); product type: 0200-lead; implant date (b)(6) 2020; explant date (b)(6) 2020.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 provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the pre ops notes stated the lead was found to be tunneling down caudally and that to fully remove the lead the hcp needed to make additional incisions.The lead was successfully removed.
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Manufacturer Narrative
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H3: analysis of the ins (s/n (b)(6), revealed that the implantable neurostimulator (ins) passed functional testing.Analysis of the lead (lot# va1xhuf) revealed environmental stress cracking (esc) on the outer insulation of the body of the lead which did not affect the function of the device.Electrical testing determined that continuity was complete and there were no electrical shorts between the circuits.Analysis identified that the outer insulation of the lead was separated in the body of the lead at a butt joint at the distal end of the lead; consistent with explant damage.Continuation of d10: product id 3889-28 lot# va1xhuf serial# implanted: (b)(6) 2020,explanted: (b)(6) 2020, 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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