MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/15/2024 |
Event Type
malfunction
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Event Description
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Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the lead tip broke off leading all the electrodes behind.Hcp is deciding whether to reimplant in the same foramen or go to the other side to potentially allow full body mri.
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Manufacturer Narrative
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Continuation of d10: product id 3889-28 lot# va12ydt serial# implanted: (b)(6)2016 explanted: (b)(6)2024 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: va12ydt, ubd: 23-dec-2019, 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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Additional information was received from the manufacturer representative (rep).It was reported that the physician abandoned remaining electrode fragments in sacrum and implanted lead on opposite side.The issue was resolved.
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Manufacturer Narrative
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Continuation of d10: product id 3889-28 lot# va12ydt serial# implanted: (b)(6) 2016 explanted: (b)(6) 2024 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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