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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
Intermittent Continuity (1121); Energy Output Problem (1431); Application Program Problem (2880); Impedance Problem (2950); Patient Device Interaction Problem (4001)
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| Patient Problems
Pain (1994); Burning Sensation (2146)
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| Event Date 06/07/2022 |
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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 (pt) regarding an implantable neurostimulator (ins).The reason for call was that settings not available was appearing when trying to increase stimulation and troubleshooting was not resolving the issue.Pt stated that they tried switching to other groups and that the other groups worked to increase therapy, however group a was not allowing them to increase the therapy as settings not available would appear.Pt tried resetting the controller as well.Pt mentioned that the ins seemed to recharge very quickly last night which was unusual.Pt stated that the ins started sending higher jolts of electricity and then stopping randomly.Pt stated that they had pretty severe pain and that the ins was their only form of therapy as they didn't have pain meds.Troubleshooting redirected pt to their physician to further address the reported issue.
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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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Pt reported getting jolting sensation with his group a at times during the juneteenth weekend.Along with this sensation, pt felt the stimulation shut off at times related to his right lead.Pt has a lead in thoracic area and one in the lumbar area.Pt subsequently saw a manufacturer representative and had reprogramming done on june 24.Additional information stated that reps have been asked not to contact the patient due to their psychological issues.This patient needs to contact their doctor to set up an appointment.They have hit the upper limit of their settings.Hcp reported that patient got an alert that the settings are too high on the device and the patient couldn't turn the stimulation down.The patient went to er last night.The caller indicated that the patient has had stim adjusted to a level that is too high for about a week.Tss reviewed information about the settings not available message with the caller and oor considerations.The caller indicated that he thought that the issue was just related to the patient making an adjustment.The caller indicated that the patient has incremented the stimulation up to a level higher than instructed by the md in the past and they had to review with the patient that they did not recommend making those types of changes.The caller was not with the patient.The caller will direct the patient to contact patient service to review how to adjust the stimulation.Patient called and patient services spoke with pt at length about them seeing "settings not available" on their controller.This has been occurring since last friday, july 1.Pt is using dtm settings on group c which he has been using most of the time.Usually pt was using around 5ma on all of his programs on c and was told he could increase his intensity by 0.2 increments each day when needed.Pt wasn't getting his pain needs met and having severe pain so he increased c1 to 9.6 as this is the program that addresses more of his thoracic pain.No falls or trauma precipitated increase in pain or settings not available message on controller.Pt is not at baseline pain levels but is still having severe pain.Pt also struggles with depression and anxiety and is in recovery from addiction.Pt went to er yesterday and spent most of the day there.Caller talked with hcp while he was in the er and hcp told the pt that the pt had increased his program 1 up too high and that this was causing the issue with the message on the controller.Hcp told the pt to shut off their stim and that hcp would call the pt today (july 8) but pt hasn't heard from the office yet.Pt also getting settings not available message on groups a and b also.Pt feeling some stim with group a but it's not enough.Tss walked pt thru shutting off programs 2, 3, and 4 and turning up program 1 on group c and other groups to try to get some stimulation therapy going for pt.Program 1 on these groups tends to give pt stim in the thoracic area where he needs it and pt prefers having a sensation with his stim.Even though pt could increase his program 1 stimulation level, pt didn't think that was going to cover his pain needs and he was still getting settings not available at times with his group c program 1 (at or around 6ma with programs 2-4 turned off).Tss reviewed need for pt to be seen for diagnostic testing and reprogramming and pt can discuss different types of programming available if pt prefers having some sensation with his stim.Callers were to reach out to hcp office on behalf of pt to see if pt could be seen today.
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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 reported that impedance on the right lead at spot 9 and 11 were overloading the battery causing the error and locked the controller to display the "settings not available, cannot provide your desired intensity settings" message.The patient's health care provider (hcp)couldn't determine alone what the issue was and they invited a manufacturing representative (rep), and tried changing to ddrm, but today changed back dtm.The steps to resolve the issues they decided to avoid the leads with impedances because their stimulation wasn't high enough to provide them therapeutic relief to their pain that was located primarily in the thoracic region.
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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 patient.They reported that the reason for call was when the pt laid in bed on their back they had the stimulation go down through their feet and as the bed warmed up the position of the head affected the current going through their feet or not.If the pt sat in the wrong position the stim goes loco and goes into one nerve and burns the nerve until they get cannot provide desired intensity settings.Pt noted they were afraid to go above 8 or 9 and cranking the ins would not help for it goes into the nerve more.Pts manufacturer representative (rep) thought since they reported impedances on the right lead and 9 and 12 were unusable and a blood vessel could cause it.Pt had controller lock up on controller on settings not available.Pt had to get reprogramed 6 times now.Pt said they had done multiple programs to probably 8 of them and they first had success then they did not see them for 4 months then they got the error multiple times at least 5 times.The patient was redirected to their healthcare provider to further address the issue.
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