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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
Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Headache (1880); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Device Overstimulation of Tissue (1991); Pain (1994); Paralysis (1997); Loss of Range of Motion (2032); Inadequate Pain Relief (2388); Neck Pain (2433); Quadriplegia (2449); Shaking/Tremors (2515); Ambulation Difficulties (2544); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Increased Sensitivity (4538); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Insufficient Information (4580)
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| Event Date 08/17/2018 |
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Event Type
Injury
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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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that prior to the implant, the patient walked 10-13 miles per week, but post implant, the patient had trouble walking and was looking at getting a wheelchair.The patient had neck and head pain immediately after ins implant.The patient went into "convulsions" after lidocaine injections and would go into convulsions every times a person touched neck area; patient mentioned any time someone touched area around ins, the patient cried and wanted to throw up.The ins was supposed to address pain in arms, but ins did not address pain in patient's arms.After implant date.Patient's legs "gave out" and patient could no longer effectively walk.The patient also developed grand mal seizures and would have seizures up to 5 times per week(sometimes 3 seizures in one day); one of the grand mal seizures paralyzed patient.The patient said they "can never get off medication." the patient said all the people they talked to in the medical field assumed the seizures were "pseudo-seizures" but patient did not think the seizures were "pseudo-seizures." after the ins was turned off, the patient said the seizures were milder.The healthcare provider (hcp) said mild seizures were due to electrical signals still being emitted by the ins to the brain.The patient mentioned that their hcp had agreed to explant the ins as early as (b)(6) 2021.The patient was trying to determine if the implant procedure had been done incorrectly or if the ins had faults.Patient services specialist emailed patient advocate about the issue and requested patient call back.Additional information was received from the manufacturer representative (rep).It was reported that rep was not made aware of the seizures or the paralyzing event.Her explant is (b)(6) 2021.
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Manufacturer Narrative
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Product id 977c265, serial#(b)(6), 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 patient had full system explanted.
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Manufacturer Narrative
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Analysis of the lead and ins found insignificant anomalies and the devices were functionally okay.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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H10.Correction to supplemental 002.Additional information regarding manufacturer report # 3004209178-2020-22240 will be submitted as a supplemental 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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Manufacturer Narrative
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Continuation of d10: product id 977c265 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: (b)(6) 2021 product type lead product id 977c265 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: (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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The patient¿s medical history includes pre-existing crps/rsd prior to having the spinal cord stimulation system placed.The patient noted that the spinal cord stimulation system was placed on (b)(6) 2018 after several failed conventional treatments for crps/rsd.The patient noted that she has anxiety and frustration due to the crps.She also noted that she had trembling in her right arm before the spinal cord stimulation system was implanted.The patient noted that after implant surgery, she was told that everything went great besides not getting full response to her left arm, but that was because the patient¿s crps was not as bad in that arm yet.Everything was looking great in the right arm (worst arm).The spinal cord stimulation system was implanted on (b)(6) 2018 for cervical spinal cord.The patient noted that things started badly almost from day one following the surgery.The patient¿s health care professionals and a manufacturer representative had told the patient that these things are normal and would go away.However, they never did, and they only got extremely worse.Other medical professionals thought that it might be due to stress or crps spreading.The patient started experiencing symptoms simultaneously within the first 4 months after surgery and continuously progressed for the past 3 years.The patient complained of extra swelling and extreme pain in the patient¿s neck from the center to her right side when she got out of surgery.This was also described as ¿a lot of digging¿ and irritation.The patient was told by her health care professionals and a manufacturer representative that this was normal and that the swelling and pain would go away and that the patient should put ice on it.The patient noted that the swelling and extreme pain have never gone away.The swelling is in her neck area and there is irritation back there as well as where the leads are.To this day, 3 years after implant, the patient still sleeps with an ice pack.The patient¿s neck still swells up, but now it is very sensitive to touch and extremely painful.The patient gets approximately 4 migraines a week and is on 300mg of topiramate a day to help prevent and sumatriptan tablet and nasal spray as needed when she gets one.The patient has tried lidocaine injections in her neck.The first time that her physician had tried the lidocaine injection, he had to abort because each time that he tried to touch the patient¿s neck, it went into tremors and was highly sensitive to the touch.So, until he could try again, he gave the patient prescriptions of lidocaine patches and lidocaine cream.The patient¿s medications to help with the pain were also upped.Eventually they were able to do the injections on the patient¿s right side of her neck which did help, but also verified the true trigger point of the most painin her neck is where the paddles (leads) are and above, running up to the patient¿s skull.The patient alleged on (b)(6) 2020 that the surgeon hit the nerves and messed up her left arm.The patient has always had swelling on her right side since surgery.Additionally, she has always had trouble balancing her right side trying to get it to communicate compared to the other side.The patient noted that the swelling has been going down, and that they have been trying to adjust ever since implant.The patient reported that she was given the go ahead to slowly get up and exercise and start walking after surgery.The patient was excited because she loves walking and hiking and did between 10-13 miles a day prior to implant.The patient started walking around her back yard at first, and then a few houses up and back, and eventually around the block.After a couple of weeks, the patient¿s right leg was getting weaker and weaker, and the patient was also in extreme pain.By (b)(6) 2018, the patient was using walls, furniture, and other people to walk.In (b)(6) 2019, the patient¿s health care professional ordered her a cane.Between (b)(6) 2019 and (b)(6) 2020, the patient was using a walker.The patient was told by two physicians that she would be in a wheelchair within two years and that there was not anything that they could do for her and that she just had to deal with it.The patient found a physician who recognized the extent of her weakness, pain, deterioration, lack of flexibility, and size of her leg.Once the implantable neurostimulator was turned on, they had trouble ¿connecting¿ the right arm, and they were not able to get stimulation in that arm.A manufacturer representative kept on adjusting and turning it up, but the only thing that was happening was that she was getting way too much in the left arm, but still little to nothing in the right arm.This is opposite of what the surgeon had told the patient right after surgery.The manufacturer representative noted at that time that everything was looking great according the clinician programmer.The patient got a second opinion who indicated that the mris from surgery show that everything goes to the left side.The last time that the patient saw a manufacturer representative was in 2019, and that was because the patient was asking for adjustments to see if they could reach the right arm.The patient noted at this time, the patient had severe pain in the middle of her back that felt like someone had jabbed her over and over with a blunt object.The patient met with a different manufacturer representative at that time who was shocked at how high the patient¿s settings were and asked if it hurt.The patient replied that she still could not feel any stimulation in her right arm, but yes, it was too strong in the left arm.On (b)(6) 2020, the patient reported that they are in pain and are always in pain.As of (b)(6) 2020, the implantable neurostimulator helps her about 30%.The pain has spread to approximately 70% of the patient¿s body.It is in her legs and hips and ¿stuff¿.(patient has pre-existing condition of crps).The patient noted that the implantable neurostimulator can help with the pain in her arms, and she can move somewhat.The patient met with another manufacturer representative in (b)(6) 2021 and agreed that the implantable neurostimulator should be turned off for further investigation into the patient¿s issues.Starting in (b)(6) 2018, the patient was trembling in both arms, and then in all four limbs.At first, the patient thought that it was part of her crps where she was still having mild tremors and then they got worse.By spring of 2019, the patient started to have mild seizures.The patient reported that she had never had a seizure in her medical history before, so this was a surprise.The seizures went from mild to conscious grand mal seizures.One episode paralyzed the patient from her neck down, and it took 48 hours to get function back into her body.The patient was having approximately 5 seizures per week and sometimes 3 in one day.They were getting out of control.The patient noted that her health care professionals thought that they might be related to ptsd because of her situation, but then the seizures seem to be stronger when the implantable neurostimulator is on.As of (b)(6) 2020, she had reported that it was to the point where she had 5 seizures per day, several seizures per week.The patient started to video the seizures for medical professionals to see/diagnose.The patient was sent to a neurologist who had told the patient hat they were pseudo seizures from stress; however, the patient did not feel that this was correct.The patient did not have any seizures of any kind until the spinal cord stimulation system was put in.The patient had trembling in their right arm before implant, but not all four limbs.The patient had been going back and forth turning the implantable neurostimulator off and on to test to see what is going on, and how she would react with the implantable neurostimulator being off.The patient had mild seizures with the implantable neurostimulator being off, and the patient noted the seizures as just functions.The patient alleged that something is not right, and that she has never dealt with anything like that.The patient does not know if "something is pressing on it" as the health care professional goes back and forth.The patient noted that nothing was happening fast in 2020 due to covid.When the patient first met their new physician, he recommended right away to turn off the implantable neurostimulator.The patient turned off the spinal cord stimulation system on (b)(6) 2021.The last time that the patient had a full conscious grand mal seizure was when she needed to turn it back on a few days before an mri on (b)(6) 2021.The patient had been very apprehensive since to turn the spinal cord stimulation on.The patient's spinal cord stimulation system was explanted on (b)(6) 2021.
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