MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Paralysis (1997); Therapeutic Effects, Unexpected (2099)
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Event Date 01/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical devices: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 29-aug-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Representative reported that patient was getting a lead revision done due to not having therapy as effective as it was during the trial.X-ray showed the lead was 1 vertebral body lower than what it was during trial.Post implant, lead was at top of t8.It was not known if lead slipped down or implanted that way.Rep reported they were able to connect to the implant before, but now when they connect to it, the ins battery shows too low to do any testing.
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Manufacturer Narrative
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Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received via a manufacturer representative from a health care professional.It was reported that the replacement lead was implanted on (b)(6) 2020 and removed on (b)(6) 2020 due to paralysis of legs.The surgeon explanted the entire system on (b)(6) 2020.There was surgical intervention for paralysis.The issue was not resolved at the time of the report.
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Manufacturer Narrative
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Continuation of d11: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2020 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2020 product type lead update to g4 of the initial report: 2020-sep-17 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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