| Model Number 37601 |
| Device Problems
Break (1069); High impedance (1291); Energy Output Problem (1431); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
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| Patient Problems
Apnea (1720); Dysphagia/ Odynophagia (1815); Emotional Changes (1831); Headache (1880); Intracranial Hemorrhage (1891); Memory Loss/Impairment (1958); Muscle Weakness (1967); Muscular Rigidity (1968); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Weakness (2145); Dysphasia (2195); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Numbness (2415); Sleep Dysfunction (2517); Cognitive Changes (2551); Insufficient Information (4580)
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| Event Date 07/28/2015 |
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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 who was implanted with a neurostimulator (ins) for dystonia, movement disorders.It was reported that the patient wanted to know if there was anything the manufacturer said about suddenly turning stimulation off after it had been on for 2 years and 9 months.Patient was asking because their stimulator was turned off 3 months ago.During the call the patient explained that they had a rare form of dystonia with dystonic tremors which were rare and breathing (dystonia of the diaphragm) that was rare and plumbing problems.They had extreme muscle tone and would go far extreme either rigid or no muscle tone.The patient said they had arid portion dystonia, some rare symptoms for their eyes; their eyes do not blink.There was tension in their eye muscles which would turn their eyes in and because their eye muscles were so tense it would swell up and push their eye forward but not all the way out of the socket.The patient said that was all going on prior to getting their device.The patient said their dbs system helps them breath.The dbs helps their eye symptoms, so they could see.When it was on their eye would turn back to the middle instead of being closer to their nose.The patient said their care team turned off the device.They didn¿t titrate it down, just turned it off and it had been off for 3 months and 5 days.The patient said it felt like their brain did not want to wake up.Since the device was turned off the patient had experienced the following symptoms.The patient said it felt like their brain did not want to wake up but slowly their brain woke up.The patient said it felt like it was under tremendous pressure, they felt like they were under anesthesia then that faded.They felt like part of their brain had woken up.The patient thought that was because prior to turning it off they were probably overstimulated (prior to turning it off).During clarification attempts the patient added their brain was still partially asleep, the front of their brain.Like the had executive functioning that was not working right.But the patient thought it would come back because it had been there off and on.It was just taking a very long time like the left side of their brain sort of woke up.They no longer had the incredible tension and most of the right side woke up but not their forebrain.Their forebrain was still under tension.The patient also said that since turning stimulation off their dystonia had not returned all the way.It was barely there, and it almost felt like a migraine.The patient said they tried some migraine medication and it helped a little but not enough to wake up the remaining part of their brain, which was the forebrain where the executive functioning was.The patient said even though stimulation had been off for 3 months and 5 days it was still helping their dystonic diaphragm breathing.The patient was saying that prior to their implant they had unique qualities of iq, add and dyslexia and after they got their stimulator those personality traits changed.The patient said they had dyslexia and add and since getting the implant they completely changed, and they did a 180.They were extremely different.Prior to the stimulator the patient had add and was scatterbrained and they were being bombarded by information.If you asked them one question they had tons of spontaneous connections and answers and since the implant that was not happening.The patient said they were highly creative, they had a master¿s in psychology and a bachelor¿s in clinical research and another bachelor¿s in art.The patient said they were equally left brained as right brained and right now there wasn¿t anything going on in their right brain in terms of psych.No right brain thinking, there was no spontaneity, no creativity.Prior to the implant they had scored genius on iq tests, there was no way that was going on now.The patient said they complained for 2 years and 9 months and no one listened until (b)(6).Patient said they tried a lot, but none made a difference in terms of reacting and their brain adjusting.The patient said they noticed when they went to a new program that was totally different from the last one they had a really hard time for 3 days and they would be asleep so on the 3rd day they went back to their old program for a couple of hours and then back to the new program and then they could handle the new program without side effects.The patient also said the during the implant they were asleep, but their programmer told them they had high impedances twice during the implant surgery and they had to try another place.They patient had researched dbs recalls and wondered if the recalls from (b)(6) 2015 or (b)(6) 2016 were related to their implant.The information was reviewed.There were no further complications reported.
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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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Additional information was received: it was reported that high impedances were adjusted during surgery so they did not place where they ideally wanted.It was noted when they tried (illegible) the replacement the wires.Especially the right side.The dbs, suddenly, happiness withdrew, depersonalized/derealized, brain too tense, blood pressure 160.Muscle weakness still happening after 4 months of turning it off.Not the same as before dbs.They may never be the same.The patient said it ruined their educational goals.It could be 9 months or a year before they would be the same as before dbs, if ever.The programming team and medical director kept going until something bad happened.Cognitive changes should not happen.Access to previous knowledge, not being able to learn new things, not being able to recall information, confusion, not working memory, no visual memory, no imagination, no spontaneous connections, no creative thinking, no flexibility in thinking, no deep thinking.Just surface thinking.Impulsive behavior, enabling too much, bad change and dyslexic changes, no ability to comprehend the writings, was scatterbrained and constantly brainstorming with dbs no ability to brainstorm or creativity.Dbs, not settle, still with it off after 4 months, it was on for 2 years and 9 months.The overstimulation was 1 year and 7 months before.They would not take it out.There were no further complications reported.
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Manufacturer Narrative
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Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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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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Additional information was received from the consumer indicating the frayed wire that was put in had to be placed three times, which damaged their brain with multiple brain bleeds and caused micro bleeds to become a dead spot.The patient has not had conscious recall for eight and a half years of college.The device was placed in the cognitive area of the brain instead of the motor skills area.No further complications were reported as a result of this event.
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Manufacturer Narrative
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Corrected outcome attributed to adverse event.If information is provided in the future, a supplemental report will be issued.
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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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Additional information was received.The patient reported "they put it in the wrong place" and it affects their cognition, body temperature, memory, and their dyslexia.It was also reported the device had been "breaking their teeth" and ruining their vision.No further information was provided.Additional information was received.The patient indicated they were not completely healed and they weren't back to normal.They also went on to say the defective device caused the neurosurgeon to punch extra holes in their brain and move the wire over.The whole dbs system was useless to them.The patient still has non-stop migraines due to the dbs withdrawal.No further complications were reported as a result of this event.
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Event Description
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Additional information was received.It was reported the patient had a frayed wire and they felt the voltage only.The patient's life functioning has been way down.It was also reported their left side never changed.The patient also had high impedance.The patient has had a lot of pain and suffering and they can't live like how they are with them risking their life and health again.The patient has non-stop migraines and they were worse off from before.The patient didn't have enough control.The patient was now facing "van life" and brain surgery.The patient has been missing since the device was implanted.They used to be a creative artist who had a love for art, spontaneous connections, energy, and a passion for life, the dbs disrupted their adhd.There was a refusal to reposition and replace the device.The patient couldn't take enough add medications without causing weakness and that was bugging them.They couldn't control their reactions.It was also reported the patient didn't have a voice to call in.The patient went on to say they had a horrible withdrawal, emotional dysregulation, couldn't feel their body, they couldn't remember anything past 2 or 3 minutes, they said things backwards, their language skills were all messed up, they couldn't communicate well for the last year to 1.7 years but especially during the last 9 months.The patient wishes they had died because their thoughts were too slow and they had suicidal thoughts.Their muscle tone was below a normal persons.The patient couldn't hold a thought and was impulsively reacting and saying things they normally wouldn't say.The patient had withdrawal impulsive behaviors and was not able to communicate well.The patient was not normally impulsive or unable to read and comprehend.The patient was born with inherited torison/generalist dystonia and it runs in their family with dystonic tremor.The patient has an appointment with the heatlhcare provider (hcp) on 2018-10-10 for a possible replacement.No further complications were reported as a result of this event.Additional information was received.It was reported the patient used to read 3 to 4 chapters a night of books but they no longer do that due to the dbs, they mention the frayed wires and their adhd.The patient goes on to say they were fighting for their life.They have dystonic breathing problems and swallowing problems.They note that most dbs fail do to placement but sometimes a frayed wire can cause a neurosurgeon to put the wire in a less than idea[l] spot.The patient also has a rare case of inherited torison dystonia with the rarest of symptoms.They could be sitting with the upper part of their leg ridged but when they stand their leg loses muscle tone from their hip down.When the dbs device was put in, they lost muscle tone - less than normal tone.Their midsection was also so tight that it was hard for their diaphragm to move enough to fill up their lungs or empty them out.They have been up all night because of it.No further complications were reported as a result of this event.Additional information was received.It was reported the patient has no er settings on their device.This has been a six month "withdrawal hell".The patient mentions the faulty brain wires from the dbs and needing two surgeries.They mention a misplacement and a refusal to fix the problem.The wire was placed too close to their cognitive area and had them "snow" for over two years.The patient has lost their voice and they can't talk on the phone.No further complications were reported as a result of this event.
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are: product id: 3387s-40, lot# va0r8a0 and product type: lead.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 patient indicating they almost died.
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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 3387s-40, lot# va0r8a0, implanted: (b)(6) 2015, explanted: (b)(6) 2022, 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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It was reported that the patient had her brain stimulator removed.Patient stated it's dangerous to people and she almost died twice, that it needs to be stopped, she had a short term memory, couldn't remember the past and people are getting harmed with it.
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Search Alerts/Recalls
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