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Model Number 37601 |
Device Problems
High impedance (1291); Migration or Expulsion of Device (1395)
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Patient Problems
Hematoma (1884); Unspecified Infection (1930); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of concomitant medical products: product id: 3389-40, lot#: 0207367152, implanted: (b)(6) 2013, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4), ubd: 28-aug-2017, udi#: (b)(4).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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Event Description
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It was reported that the patient's lead had migrated and said to be raised 15mm.On the mri of 2013 it was positioned at the inria target.At the rcp on (b)(6) 2021 it was concluded that there was no need to repeat the surgery because of the risks to the patient who already presented numerous complications of the surgery.3d reconstruction from their postoperative imaging and therapy being suspended on (b)(6) 2021 were done, but the issue was said to be unresolved with no further action planned.
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Manufacturer Narrative
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Concomitant medical product: product id 3389-40 lot# 0207367152 implanted: (b)(6) 2013 product type lead 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.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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Event Description
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Additional information was received: it was reported that the patient was also having a resumption of symptoms/tremors on the left side.Strong impedances were also measured on the left electrode (>4000 ohms).The ins was off on the right side and botulinum toxin would be initiated for the left side tremors.
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Manufacturer Narrative
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Continuation of d10: product id: 3389-40, lot# 0207367152, implanted: (b)(6) 2013, product type: lead.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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Event Description
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Additional information was received: it was reported that patient was implanted in 2012 for the first time with there are a hematoma on the path of one of the lead, few month after an infection on the neurostimulator before inclusion on psr.
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Search Alerts/Recalls
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