MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97725 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888); Undesired Nerve Stimulation (1980); Pain (1994); Paralysis (1997); Malaise (2359); Spinal Cord Injury (2432); Cognitive Changes (2551)
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Event Date 09/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: screening.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 13-aug-2024, 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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Information was received from the consumer via manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that the emergency room hcp called the rep at 1:35am and asked about the patients device taped on her back, patient presented at the emergency room with extreme back and leg pain and some paralysis.Rep stated the trial went as planned without any complications.There were no concerns with lead placement, inter opt testing and post opt programming.Rep explained to emergency room physician that this was a temporary lead placement in the epidural space made to be taken out in the clinic at the end of the trial.Rep advised to turn off stimulator.Hcp wanted to know if they were able to have an mri with leads in place however rep stated they were not mri compatible.Hcp called again and stated they would be removing the leads.Rep explained how to remove the leads.Hcp removed trial leads and patient had an epidural decompression/ hematoma.
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Event Description
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Additional information was received from the rep.It was reported that the cause of pain/ leg pain/ paralysis was due to the epidural hematoma.Ens was discarded.An emergency spinal decompression was done.As of now patient still has some paralysis in her legs.
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Manufacturer Narrative
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Continuation of d11: product id: 977d260, lot#/serial#: (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: screening device.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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Manufacturer Narrative
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Continuation of d10: product id: 977d260, serial#: (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: screening device.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 from a patient's representative regarding an external neurostimulator (ens).The reason for call was pt had the trial unit placed on (b)(6) 2020 and the next day had it removed and was rendered paralyzed.Caller noted that a few hours after the trial procedure pt did not feel well and went to the er, she had a major bleed out and compressed her nerves, they operated on her but she was rendered paralyzed and is still paralyzed today and doesn't want to live.Managing hcp and er hcp asked/unknown, per caller the "pain management supervisor" and (b)(6) clinic said they send the device back to medtronic for analysis.Rfc is to check on the status/result of the analysis.Caller still had the 97745fa unit indicating the ens was 97725, sn# asked/unknown.Pss found no record of return analysis.
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Manufacturer Narrative
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Continuation of d10: product id 977d260 ,serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020.Product type screening device.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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A consumer reported that the patient was in surgery at 1:35am on (b)(6) 2020 and that the surgery was 4 hours long.It was noted that they had to remove 4-5 vertebrae, and that the patient is still paralyzed from what happened to her.
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Manufacturer Narrative
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H6.Patient code e0138 does not apply.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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Manufacturer Narrative
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H6.Patient code (b)(6) does not apply to this event.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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