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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
Migration or Expulsion of Device (1395); Use of Device Problem (1670); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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| Patient Problems
Pain (1994); Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/23/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 97745 lot# serial# (b)(4), product id: 977a260 serial#: (b)(4), implanted: (b)(6) 2021 explanted: product type: lead product id: 977a260 serial#: (b)(4), implanted: (b)(6) 2021 explanted: product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 19-jan-2025, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 11-dec-2024, udi#: (b)(4).(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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The patient reported on (b)(6) 2021 that they were having issues with recharging since implant.They explained that it was taking them a long time to find the implanted neurostimulator (ins) when trying to start a recharge session, and charging was taking longer than they expected (over an hour to as long as the whole day) to charge the ins.It was confirmed that they no longer had bandages from their implant surgery a week prior.During the call with patient services, they tried recharging the ins and got the "no device found" screen.After repositioning the recharger therapy module (rtm), they reported getting the poor recharge quality message.They were redirected to their physician for further assessment.On (b)(6) 2021, the healthcare provider the patient was working with reported information already reported by the patient.They also provided additional information stating that the patient couldn't get the ins to charge past 60%-80%.There were no known error messages seen, but when the patient went to check the charge level they would find that the ins was no longer charging.They also reported that the patient was having difficulty positioning the rtm appropriately, but stated that the patient was charging the ins in a recliner and when charging they would recline even further back, which could have been contributing to the coupling issues.They were going to meet with the patient on (b)(6) 2021 to assess the patient's recharging practices.The ins did end up discharging and as a result the patient had a return of pain.The return of pain resolved after the patient charged the ins back up.On may 5, 2021, additional information was received.It was reported that the patient was charging with excellent recharge quality but still had to reposition the rtm many times throughout the recharging session because any movement was interrupting charging.The patient was not able to get a full night's sleep because they had to charge in the middle of the night.The patient reported that their experience with the device had not been good for them because having to recharge in the middle of the night was aggravating them.The patient received a replacement rtm from the representative (rep) they were working with, and that hadn't resolved the issue.They tried resetting the patient controller as well, without resolve.Additional information was received on may 17, 2021 from the rep that was working with the patient.They were responding to an inquiry for additional information.The cause of the frequent recharging the patient was having to do was partly due to the differ ential target multiplexed (dtm) programming they were using.Additionally, the patient was having to recharge three times a day because they weren't able to get the ins charged past 60-80% charge because they were having trouble with coupling and maintaining coupling.The cause of the coupling issues was not determined.They did try replacing the recharger therapy module (rtm), but that didn't resolve the issue entirely.The patient was able to charge the ins to 100% most of the time, but they were still having trouble maintaining coupling.Initially it was believed that the patient's bmi was a contributing factor however, after meeting with the patient and assessing the ins site, they reported that the ins was within 3 cm of the skin and it was not tilted; it was planar sitting flat with the rtm.Since being able to charge the ins to 100%, an updated recharging report had not been obtained, so it was unknown if the frequency of recharging had improved nor how long it was taking the patient to charge up to 100%.Additional information was also received.On (b)(6) 2021, fluoroscopy was performed, which showed that both leads had migrated grossly.The lead with the active programming had migrated more than the other lead that was not being used.The other lead was not being used because the out of regulation (oor) message kept occurring despite using an intensity of 6 ma, use of all 4 channels, and impedances between 800-1300 ohms.The cause of the lead migration and the oor message were unknown as there was no information provided by the patient to indicate a fall or some kind of trauma had occurred.As a result of inadequate pain relief and the lead migration, the patient was scheduled for surgical intervention to revise or replace the system.A request was made to have all explanted devices returned for analysis.
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Manufacturer Narrative
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Continuation of d10: product id 97745 lot# serial# (b)(6) product type programmer, patient product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 product type lead h10.Additional information regarding manufacturer report #s 3004209178-2021-07744 and 3004209178-2021-08746 will be submitted as supplementals under this report.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 when the patient lies back on her back to produce a paresthesia effect and sometimes she feels like stimulation is weaker.The caller indicated that the patient is programmed with dtm therapy settings.The amplitudes are program 1 6.6ma and programs 2, 3, and 4 are 8.6ma.The patient is charging 3 times each day.The caller indicated that the patient was not sure when the stimulation felt weaker or if it was related to the time following a charging session.The patient was seeing a message during charging sessions.The caller did not have any specific information about what information was displayed in the message.Caller reports pt seeing "settings not available" on controller.Pt using dtm settings with 6.X ma for intensity and imped that have been in 1100-1300 ohms range.Technical service reviewed that dtm settings can create more load on system.He will recheck impedances on may 4 to make sure nothing has changed.Tss reviewed that as imped increase even slightly towards 2000 ohms, this can affect output of ins.Patient is programmed with dtm and all groups with 4 programs are showing setting not available.Caller reports setting available started about 3 weeks ago, (b)(6) 2021.Caller reports impedance are within normal range 800-1400 ohms.Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The patient reported their lead wire moved three weeks after implant.Pt has surgery scheduled to have a lead revision on (b)(6) 2021.Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that when the lead revision was occurring, the health care professional opted to replace the ins as well because she notedthat the intellis battery went from %30 to %0 within 30 minutes during the surgical procedure.Technical services specialist (tss) asked if the rep had ins on a short circuit or something and caller said all impedances were fine.The caller said that she was able to connect to the ins fine pre-op and the pt's ins felt loose in the pocket.Additional information received.Patient reported they believe there is something wrong with their charger.In order to keep it going patient has to charge it continuously and can't move when recharging.Patient reported nothing has worked.The patient was sent a new remote device, but there was no improvement.So it was then decided to redo the procedure.The patient reported that the spinal cord stimulation system was removed on (b)(6) 2021 because the original device moved to a position which retarded charging.No one could understand why the problems were occurring.The patient also noted that some of the leads had moved.The patient noted that after day one of having the procedure, all seems good.The patient noted that the next few days will tell.The manufacturer representative reported that one lead was replaced as it had migrated, and the implantable neurostimulator was replaced.
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Manufacturer Narrative
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Continuation of d10: product id 97745 lot# serial# (b)(6) product type programmer, patient product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2021 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 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 during the call, caller stated that patient has to run dtm programming around 7-7.5 ma in order to get pain relief and impedances are increasing each time caller sees the patient.Caller stated that patient can feel when ins is getting low (to around 30%) due to onset of pain and inquired about how impedances and oor factors into this.Caller stated when they typically see the patient, the ins is around 25-30% charged and are seeing oor prior to patient feeling paresthesia.Tss reviewed how impedances, low battery and high settings can affect seeing stim output and oor. caller stated patient has had many issues with system.
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Event Description
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One lead was revised and one lead was discarded.
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Manufacturer Narrative
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Concomitant medical products: product id 97745; serial# (b)(6); product type programmer, patient product id 977a260 lot# serial# (b)(6); implanted: (b)(6) 2021; explanted: (b)(6) 2021; product type lead.Product id 977a260; serial# (b)(6); implanted: (b)(6) 2021; 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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Manufacturer Narrative
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Continuation of d10: product id 97745 lot# serial# (b)(6) product type programmer, patient product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2021 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 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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Manufacturer Narrative
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H3: product id# 97715, s/n (b)(6) was returned for product analysis.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.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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