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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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| Model Number 97715 |
| Device Problems
Break (1069); Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431); Application Program Problem (2880); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/05/2022 |
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Event Type
malfunction
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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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Information was received from a patient on may 6th who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that all of a sudden they started to get settings not available screen.The patient tried resetting the patient controller but that did not work.This morning the stimulation started to work again but then a little bit after, the settings not available came up and the patient was not feeling stimulation.The patient confirmed the ins was charged.The patient unlocked the patient controller and reported being on group b, which they were on yesterday as well.The patient had a group a that they tried but again got settings not available.The issue was not resolved.The patient would visit their health care provider once they got back to the united states.Additional information was received from the pt on june 22nd reporting that the that they had a fall the day that they got settings not available but said they might not have mentioned it when they spoke with patient services specialist (pss).Pt says after this call they met with a rep at hcp office but doesn't remember their name.Pt says hcp did do an xray "because i was complaining of pain but he said i don't see any stenosis but i don't know if they looked at the leads when they did the xray".They said this rep did some reprogramming and said it was the most extensive reprogramming that they have had and they added a group c and added more settings on each group.Pt says they were impressed with reps ability to do this reprogramming.Pt says this rep had mentioned that they would have to tweak it so they would have to recharge more often, and pt said that the rep eluded to say something like "something had changed after that fall".Pt said after the fall they had found the stimulation would go on and off by itself just like it did today.
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Manufacturer Narrative
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Continuation of d10: product id: neu_unknown_lead, serial# unknown, product type: lead.Product id: 97745, serial# unknown, product type: programmer, patient.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 received reported that the patient was seen for reprogramming on 2022-jul-07.The patient did see the settings not available.Cannot provide your desired intensity setting screen.The message cleared after reprogramming.Impedance testing was performed and contact 0 showed red do not use.Contacts 1 and 7 were orange with a possible open and the rest of the contacts were in green impedance range of 800-900 ohms.The patient felt stimulation and paresthesia after programming but felt the intensity different since the fall in may.The patient had an mri scan done and the ins turned off mri mode on its own.An x-ray was performed and showed a tiny ¿maybe¿ one contact down lead migration.The reporter stated that when the usage diary was checked the patient indicated that he had stimulation turned on over an hour while the patient was sitting on a bench at the park.The diary usage showed 0 use.Overall stimulation usage was about 21 percent.The patient reported that they turned adaptive stimulation on, on the day of report.The patient was walking at home and turned adaptive stimulation off.The reporter stated that the adaptive stimulation was not working properly.The reporter stated that with certain positions the intensity was set at 0 ma.When the reporter exited workflow on the tablet the patient connected to his controller, and the intensity was set at 0 ma, but when the patient locked and unlocked the controller the intensity was back up to 6.9 ma.The reporter stated that the only position skipped was left laying and laying front.The rest of the positions did have an assigned intensity.The patient was reprogrammed and a lead revision was being considered.
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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 from the manufacturer representative reporting that the patient fell in (b)(6) 2022, and since the fall the stimulation had been turning off on its own.The patient was also seeing "weird messages" on the controller (the exact messages was not known).It was noted that the patient had an mri the week of (b)(6), 2022, and after the mri, the controller exited mri mode and turned stimulation on without the patient doing anything.The manufacturer representative stated they would be seeing the patient sometime in the next few weeks to interrogate their system.
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Event Description
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Additional information was received from the manufacturer representative reporting that the patient reported that they started having the same stimulation turning off and turning on again occurred again on (b)(6) 2022.The patient also reported that on (b)(6) 2022 they set the stimulation level on two programs and a few minutes later the intensity decreased to 0ma on both programs.When the manufacturer representative met last time with the patient, they set up adaptivestimulation (as).The patient started having weird issues, so they turned as off at that time.The x-ray showed that the leads did not migrate.The manufacturer representative programmed the patient only using the lead that did not have the high impedance indicator.Further stated that the patient switched the ins out of mri mode and then the remote took the device out of mri mode automatically.The manufacturer representative would follow-up with the patient and health care provider (hcp).
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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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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 from the manufacturer representative (rep).The patient reported a few events since he fell earlier this year.The device has been reprogrammed so the initial behavior has resolved; however, the patient experienced a few occurrences where stimulation seemed to be turning on and off on its own.It was unclear if this was just due to positional changes.It was also noted that the stimulation usage report seemed inaccurate to the patient.From his experience, the device was on for most of the day and the graphic would display a small percentage of time.He also reported the behavior related to mri mode.He completed troubleshooting with patient services and did not feel it was related to the controller.When the rep spoke to the manufacturer's technical support, they recommended getting complied data from the ins, and the provider and the patient were wondering if the reported behaviors were most likely related to the leads/impedance or if there was something else happening to the ins.A device data report and two session reports were provided.The impedance information on the session reports showed do not use status on electrode 0 with all pairs measuring 40000 ohms, avoid status on electrode 1 with pairs measuring from 27810-40000 ohms, and avoid status on electrode 7 with pairs measuring between 19650-40000 ohms.All other electrodes had good status.Additional information received from the rep noted that the provider would be meeting with this patient on (b)(6) 2022.
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Event Description
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Additional information was received reporting that there was no connection with one of the leads.A cat scan in august indicated of the leads were broken.
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Manufacturer Narrative
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H6 codes belong to the 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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Manufacturer Narrative
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Continuation of d10: product id neu_unknown_lead lot# serial# unknown implanted: explanted: product type lead product id 97745 lot# serial# unknown implanted: explanted: product type programmer, patient 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 patient.They will be meeting with their hcp/pain management doctor's office with their representative on (b)(6) for reprogramming due to their ongoing problems since their fall in may.
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Search Alerts/Recalls
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