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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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| Model Number 37612 |
| Device Problems
Break (1069); Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616); Communication or Transmission Problem (2896); Loss of Data (2903)
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| Patient Problems
Fall (1848); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Discomfort (2330); Numbness (2415); Shaking/Tremors (2515); Electric Shock (2554); Paresthesia (4421); Unspecified Nervous System Problem (4426); Insufficient Information (4580)
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| Event Date 03/31/2022 |
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Event Type
Injury
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Event Description
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Holdvs 9/30 it was reported that the patient got their stimulator for et (essential tremor) of their right hand.The patient reported that starting a couple of months ago, they noticed a change in their symptoms with a new symptom of increased neurological difficulties, gross shaking on their right hand/side and more falling.The patient said they saw their doctor for these issues on friday (b)(6), 2022 but did not bring their programmer.The hcp used their own equipment and the patient felt that "temporary, startling, uncomfortable, shock feeling" they normally do when the doctor does programming but that shock feeling was much worse, lasting 5-10 minutes, they felt it all the way up into their teeth and jaw but that got less and less as the doctor was adjusting.The patient said the doctor told them they could not adjust the right side, they could not get a reading on the right side, they had no way to change it and they decided it was as high as they could.The hcp decided patient was now experiencing "disintegration of the nervous system", the patient is beginning to loose functioning.The patient said since friday, their right side has become like it was prior to getting dbs, they can hardly get a spoon to their mouth.The patient said they were calling today for assistance, because their programmer showed different pictures, since friday.The patient said prior to calling they saw a picture of a standing man and the programmer, that blinked and prior to friday, that picture never blinked.Also, they used to see their right and left side numbers now they did not see those numbers.Worked with patient to sync and do a check.The patient described seeing the on/ ok status screen and simple mode rather than advanced mode.Further clarification revealed patient chooses not to make any changes to their setting on their own, setting changes only happen when patient sees the doctor.Reviewed the doctor may have changed from advanced to simple on friday.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Patient reported they are very thin they can feel their stimulator sticking out.The patient called back and stated they called their doctor, explained their symptoms and will see the doctor tomorrow.Patient said prior to the doctor making adjustments, they had 170 on the left and 390 on the right, but when the doctor worked with their settings on friday, they felt the electrical charges, extreme discomfort in their left arm and could not stand it so the doctor reduced it down until that feeling went away and left it 170 left and 170 right (not 390 where it was before) and patient felt that must be why the patient's symptoms came back in their right arm, (cannot hold a spoon, cannot hold a coffee cup).The patient said they were looking in the book and want help to get advanced mode back.Worked with patient to check for the functioning but patient was not successful to access ability adjust their setting.It was explained that the ability to change it is stored in the implant, not the programmer and the doctor had removed their ability to make adjustments on friday.The patient said they will ask tomorrow for the doctor to give them back their numbers.Additional information was received from the hcp who reported the patient's programming was wiped out today when she connected her tablet to the patient's implant.The app version explained why patient's implant settings were erased.When hcp re-entered settings, she used lead 3387.Patient felt her teeth being numb and she had sharp sensation down the arm.Patient felt it on her left arm but not the right.After the hcp reprogrammed the appropriate lead model to 3389, the patient still felt the same.Hcp inquired why patient still has side effects; technical services(ts) told hcp it could be the side effect of therapy being off, and it's hard to predict when patient will recover.This was based on the assumption that hcp got the right settings reprogrammed.Hcp wanted rep paged to check system and to assist.The issue was not resolved through troubleshooting.The patient also had complaints of why she saw the image of the man on the remote, the image of the patient programmer(pp) asking patient to position the antenna/pp over the neurostimulator.Patient said she never saw the image before.
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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 consumer.The patient repeated information regarding how their ins was "not set correctly." the patient added that their hand was trembling like it did before they got the dbs.The patient mentioned that their rep was unable to set the settings for their right hand "back to what it was," which resulted in them not being able to hold a spoon.The patient noted that their hand was getting to be an emergency situation.The patient stated that they heard from the manufacturer's representative (rep) last thursday, who told the patient that they would try to set up an appointment for today.The patient mentioned that they called patient services yesterday to request to speak with a rep and heard from the reps colleague (name unknown), but an appointment was never set up.The patient was upset because they continue to have therapy issues and do not have an appointment set up yet.
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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 consumer who reported that the patient's neurologist had not heard from a local rep yet.The patient repeated information regarding uncomfortable "electronic feelings" in their body, specifically through their arm and in their teeth.The patient mentioned that their therapy settings were not set as high as they had been for the last 4 years.The patient also repeated information regarding their neurologist calling technical services yesterday, noting that they were unable to reset their programmer, and the issue was not resolved on the call.The patient stated that they need this issue resolved as soon as possible.The patient called back reporting the situation was not corrected but they will meet next week with the medtronic rep and the neurologist.The patient said the doctor lowered the left hand but it is still too tingly.The patient said unfortunately their hand was trembling but they had told their doctor: "let me see if i can stand it".The patient said the doctor gave them the ability to lower it and requested assistance and was successful to lower their left side from 1.20 to 1.10 and confirmed the tingling was already better.The patient also said, they still do not understand why when their doctor makes adjustments and ever since implant, they only feel electric shock in their left arm but they have never felt electric shocks in their right arm during adjustments and their right arm is 390.The patient said the doctor was able to increase the right to 390 without any reaction in the right arm but when they were trying to set back their left arm, it was excruciating, they could not get the left arm setting back to what it was before (170).The patient reported, when using their programmer to make the left side adjustment, they do not have a highlighting box that moves up and down when they use the navigator keypad and confirmed they do not need to use the navigator to make further adjustments.Tried to review normal navigator button function with patient and asked patient to use the programmer to check it but patient declined.
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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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Patient called back asking patient services (ps) to send message to rep.Pt said rep, had caller them and talked to them but pt didn't have rep's #.Ps reviewed role of rep and redirected pt to hcp.Pt said that neurologist had told pt that there was an upcoming appointment with her and rep but pt hadn't been able to get ahold of hcp to find out the date of the appointment.Pt said issues reported in original call continue.Pt was escalated.
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Event Description
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Pt said they just saw their neurosurgeon and was told to live with the implant turned off for a while to see if the patient saw any difference.Neurosurgeon said the plan was to either remove the implant completely or to place the implant in a different part of the body.The neurologist wanted to see if the patient would miss the dbs with the therapy off.Pt asked ps how to turn therapy off and ps reviewed information with pt.Caller repeated information from previous calls.Caller said they had gone into the neurologist to see if there was anything they could do about these symptoms and that was when the hcp put the programmer on the patient and they felt the "severe" electrical charge.Patient said then hcp turned off both sides of the dbs without telling the patient.Patient said in two days they noticed their right had was like before they had dbs and so they went back in the day after memorial day because of this and hcp admitted to the patient that they had turned off their dbs.Hcp was able to reprogram the right arm without shocking and hcp tried to reprogram the left arm but had no luck because the left arm was still the same.Patient went to another dr.About their left arm/hand not being helped (current managing hcp).The caller said since then the skin over the implant battery had thinned out and implant was going to be removed.They added that where the lead wire comes down from their head, scar tissue had formed so it was a little bit painful to touch, implant in chest was also painful to touch, and that their hcp informed them that 1 of the 4 probes was not in the right place in the patient's brain and the hcp said the solution was to put the implant in the stomach.The caller said they had been living with essential tremor and their hand like this for so long they didn't want a whole new dbs implanted system going to their stomach and added that they weigh 111 lbs and wanted the implant removed.Patient services (pss) wanted to add that during the call, the caller mentioned the pt's neurologist said that manufacturer had made "some changes" and that they had issues with other dbs patients as well.When asked if pt had any info on the other patients, the pt said no and said ps can f/u with hcp about that if they wanted to.
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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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Continuation of d10: product id 3389s-40 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: product type lead product id 3389s-40 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: 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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Pt said that they were having device removed so that they wouldn't be following up with mdt anymore.Pt mentioned new detail that managing hcp thinks patient may have parkinson's.
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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id 37642 serial# unknown: product type programmer, patient product id a610 serial# unknown: product type software product id 37761 serial# (b)(6): product type recharger product id 3389s-40 serial# (b)(6) implanted: (b)(6) 2018: product type lead product id 3389s-40 serial# (b)(6) implanted: (b)(6) 2018: 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 received from the consumer reported they had their implant removed from their chest because it was starting to come through the flesh and the lead in the brain was ¿snapped and hadn¿t been placed accurately so their left hand wasn¿t able to be programmed.¿ the consumer mentioned that while their device was working it was life changing and wished they had gotten it earlier, but now they were just left with scars.The consumer wanted to donate their external equipment but noted the covering on the desktop charger cord had started to recede.
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