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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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| Model Number 97715 |
| Device Problems
Intermittent Continuity (1121); Disconnection (1171); Failure to Deliver Energy (1211); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
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| Event Date 01/08/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 39565-30, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.Other relevant device(s) are: product id: 39565-30, serial/lot #: (b)(4), ubd: 27-may-2014, 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 a patient regarding their implantable neurostimulator (ins).It was reported that ever since the implant, he has not had reliable therapeutic benefit.Patient has 15 electrodes on his leads and only 5 work.Patient is not getting the stimulation that he was getting before.It seemed like it was working good but then wouldn't cover right side of his back.Patient would go for reprogramming and get it a little better but then the legs would quit working.Patient would get a sharp stimulation sensation in his left side of ribs so then he would go again for reprogramming and got rid of that.The reps were never really able to get the stimulation settings to where he needs them and he would like to meet with someone again to discuss this.Now he is having a problem where when he breaths in he loses stimulation sensation on the left side and when he exhales the sensation comes back.So he thinks he has a broken lead.Patient was redirected to their hcp.No further complications were reported.Additional information was received from the consumer via manufacturer's representative.It was reported that the patient experienced a loss of paresthesia from tonic scs stimulation even though the ipg was functional and charged.Patient was getting oor on patient controller.No known contributing factors.Patient will have imaging and other studies performed.Patient to follow-up with surgeon to investigate possible surgical intervention if imaging shows damage to leads or extensions.Issue not resolved at this time.Intervention planned.No further complications were reported/anticipated.Additional information was received from the rep.It was reported that the rep saw the patient for his post-op appointment on (b)(6) 2020.According to the notes, high impedances were observed in the or and in the recovery room at the time of battery replacement.The cause was unknown.To rep's knowledge, it has not been confirmed if the lead was broken.On (b)(6) 2020, at the post-op appointment, rep reprogrammed around the bad contacts to provide better stimulation coverage.It was unknown what actions/interventions took place, if the issue was resolved.Rep believed that the hcp was aware.No further complications were reported.
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Manufacturer Narrative
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Product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2010, product type: lead; product id: 3708140, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2020, product type: extension; product id: 3708140, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2020, product type: extension.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 the rep.It was reported that at the patient appointment on (b)(6), the patient still had 5 electrodes with bad impedances.Rep was able to program around those to get the patient the appropriate coverage.The patient said the coverage was still not as good as he had before the january battery replacement.It was unknown why the extension came out of the header block.The 40 cm extensions were not saved or returned to manufacturer as the hcp did not believe they caused the malfunction.Hcp just thought the 60 cm extensions would provide a little more slack.After replacing the extensions, since we still have bad impedances, he is convinced the problem must be in the lead.However, he did not want to replace the lead at this time.He wants to see if the patient is getting satisfactory coverage before doing anything else.No further complications were reported.
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Manufacturer Narrative
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B5: added text for additional information, was left out in the last submitted regulatory report.G4: corrected notified date of the new information to 2020-may-08 from 2020-may-22.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 the rep.It was reported that patient went home after revision surgery and battery was depleting without it being turned on and was down to 40%.Patient charged to 100% just before coming into clinic and it is already down to 90%.Impedances out of range and he is getting oor.While on the call, caller was able to switch electrodes and get coverage one side.Patient also noted that his battery has been draining every day.It was advised to the caller that they should reprogram around best pairs and patient should monitor going forward.If issues do not resolve then, last step would be to discuss with hcp.No further complications were reported.
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Manufacturer Narrative
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The correct aware date for the last submitted additional information is 05/22/20, not 01/22/20.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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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 the patient had a revision on (b)(6) 2020 due to high impedances.X-rays were taken prior to the surgical intervention, and the imaging results indicated that one extension had come out of the ins header block.The physician replaced the extension with the 60 cm extension as the shorter 40 cm extension seemed a bit tight.No further complications were reported or anticipated.
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Event Description
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Additional information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins).It was reported that the patient had an infection of the surgical site from the revision surgery.The entire system was explanted on (b)(6) and all products were discarded by the customer.The product will not be replaced in the future.The issue resolved.No further complications were reported or anticipated.
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Manufacturer Narrative
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Continuation of d11: product id 3708160 lot# serial# (b)(6) implanted: (b)(6) explanted: (b)(6) product type extension product id 3708160 lot# serial# (b)(6) implanted: (b)(6) explanted: (b)(6) product type extension product id 39565-30 lot# serial# v483023010 implanted: (b)(6) explanted: (b)(6)product type lead product id 3708140 lot# serial# njb082914v implanted: (b)(6) explanted: 2020-05-08 product type extension product id 3708140 lot# serial# (b)(6) implanted: (b)(6) explanted: (b)(6) product type extension 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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