MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099)
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Event Date 06/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had been having issues charging the ins.After about 5 seconds of charging the controller would show that the ins was finished charging when it was only at 30%.They noted that they didn't move or touch the recharger (rtm) when this happened.They hadn't been able to get the ins charged to 100% because of this issue.They occasionally saw the cannot find a device screen when trying to charge the ins.They had taken the battery pack out and reinserted it, which resolved the issue temporarily.The patient further reported that they had experienced the original pain and when they checked the controller they saw the ins was depleted.The ins took a long time to charge back up because it was starting at 0% and they typically charged when it was down to 50%.During the call the pat ient charged the ins from 30-40% in about 10 minutes with recharging excellent quality.Additional information was received from the patient on july 24, 2020.It was reported that they received the new rtm and the situation hadn't improved; the patient said that the controller continued to show "finished" when the controller reached 30%.A replacement controller was sent to the patient.Additional information was received from the patient on july 28, 2020.It was reported that they did receive the replacement recharger therapy module (rtm), but there was no improvement after getting the replacement.They then had the patient controller (pc) replaced, but they were continuing to have so many problems recharging their ins.They explained that the replacement controller had went into mri mode but the patient hadn't activated mri mode.They also noticed that when they would bend over, they would always feel a little buzz.Also, on july 26th-july 27th, when recharging the ins, the pc indicated it could not locate the ins, which occurred three times.It took the patient 5-7 minutes to find the ins.Also, when the pc was charged to 100%, and the ins was at a 30% charge, the stimulation had turned off by itself, and the patient confirmed that the controller said "stim off".When they were rechar ging the ins, the pc displayed "finished", but the ins was only charged to 30%.It took the patient about an hour to charge the ins from 30% to 40%, and during that time, the controller charge had decreased from 100% to 70% charge.The patient confirmed that when they were recharging, they were either standing up or lay down on pillows, but they were using the recharging belt.They confirmed that when they recharge, they plug the controller in, tap the "lock" button on the controller, and then put the rtm into the recharging belt.They also noted that they had only been able to get the ins charged to 100% once, but never had an issue before with that.They also explained that the controller screen would go blank when recharging the ins, so they were checking the controller every two minutes.Patient services reviewed recharging best practices with the patient, that the "finished" screen displays when the rtm moves away from the ins and the connection is lost, that the pc screen will go dark during recharging and the green blinking light indicates the ins is still actively charging.The patient commented that they didn't know what the green blinking light meant.It was recommended that the patient charge every day to top off the ins instead of charging every other day.During the call, the patient was able to connect to the ins.The pc charge was confirmed to be at 100% and the ins charge was at 50%, the green light was blinking, and they had excellent recharge quality.The patient was instructed to use the best practices described to them by patient services and to keep notes of what happens and when.If after trying the best practices the recharging issues don't resolve, then they should either call patient services back for further assistance with troubleshooting or to see their doctor and/or a manufacturer representative (rep) to check the devices to address this event.
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Event Description
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The patient had contacted the manufacturer representative because the implantable neurostimulator was not holding a charge.It has to be charged twice a day and it used to only require charging once every 3 days.The patient is also getting "weird error messages", but the specific information regarding the error messages are not known.It was confirmed that the error messages were not the settings not available message.
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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 a manufacturer representative (rep).It was reported that they would need to bring the patient in for troubleshooting.
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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.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 a healthcare professional (hcp) via manufacturer representative (rep).It was reported that the rep had not seen the patient in clinic.He was concerned about covid.The rep also called tech services to report the issue and ask for suggestions.They recommended to meet with the patient which again, the rep offered and would continue to offer.The rep would meet with the patient when he wished.
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Manufacturer Narrative
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Concomitant medical products: product id 97755, lot#/serial# (b)(6), product type recharger product id 97745, lot#/serial# (b)(6), product type programmer, patient product id 97755, lot#/serial# (b)(6), product type recharger 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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Patient reported that for "the last month" he has noticed a change in how frequently he has to charge ins battery b/c the battery depletes more quickly than it used to.Patient said issue had become worse, patient reports no falls/trauma and no changes in settings.Patient kept saying "it's eating through batteries" and "it's sucking the battery".Patient confirmed he was not referring to his controller battery but to his ins battery.Patient said the device worked great for his pain so he didn't think it was a lead/ins placement issue.Patient said he was told there have only been 2 device failures before so he didn't think the implant itself was the issue.Patient said his dr.And "the medtronic people" told him this but that he didn't have any further information about this.Patient services (pss) reviewed how settings/usage can effect recharge interval and redirected patient to hcp.Patient said that he had told his rep, mathew, aboutthis issue and is going to talk to mathew about it on monday ((b)(6) 2020).Patient reported that he had received a replacement rtm and controller before because he had issue with ins taking a long time to charge because charging session would say "finished" whenhe wasn't stopping charging session himself.Patient said the replacement equipment had resolved his issue for a while but that the same issue was back.Patient reported he was having issue with ins not charging up to 100% and taking a long time to charge (only getting ins charged up 10% in 3 hrs on excellent sometimes) because the charging session will stop on its own without patient losing connection or stopping charging session and say "finished".During call pss walked patient through checking that recharging speed was on fastest setting, it was on fastest setting (4).Pss emailing repair to send new rtm to confirmed address on file.Patient said the device worked so well for his pain that he was able to stop taking a ton of his pain medications and didn't have medications to fall back on so he relied on the device a lot.Patient said the charging issues were getting to be very cumbersome and it had become a chore to keep the implant charged so that he could have therapy.
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