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Author Topic: Deep brain stimulator - Neck  (Read 29192 times)
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dennis100
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« Reply #60 on: January 10, 2015, 05:35:37 AM »

Model Number 37603
Event Date 11/19/2014
Event Type Injury
Event Description
It was reported the patient was in the hospital since (b)(4) 2014 with a headache and sharp pains in their head and neck. The patient was not sure if it was related to their device or therapy. When the patient was in the shower and washing their hair, they hit a really tender spot when they were scrubbing their scalp. The patient felt the tenderness ¿three fingers¿ from the tip of their ear. The patient had called their healthcare professional (hcp) and they stated that where the patient felt the pain was where the connector was implanted. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389s-40, lot# va00cfp, implanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318262
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dennis100
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« Reply #61 on: January 10, 2015, 08:29:43 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 8840, serial# unknown; product type programmer, physician product id neu_unknown_lead, lot# unknown; product type lead product id neu_unknown_ext, serial# unknown; product type extension product id neu_unknown_prog, serial# unknown; product type programmer, physician. (b)(4).

Event Description
It was reported, the patient had a loss of efficacy which was unrelated to the stimulation therapy. They arrived at the emergency room due to the return of tremor. It was after a programming session that had occurred earlier the day prior to report. Their symptoms were similar to when the implantable neurostimulator (ins) was turned off and they also had a tongue sensation of ¿being pulled backward. ¿ the tremor started immediately after the programming session with their managing physician. It was noted they were able to change the patient¿s settings back to the settings they had in 2013. There was an immediate improvement after the rate was changed. However, the patient still had a tremor. The patient hadn¿t had any medication recently which they thought could be another cause for some tremor. Additional information reported the ins battery voltage was at 2. 73v and the stimulation was on. The patient had head pain, neck tightness, and left side tremor return to ¿pre-device implant. ¿ two weeks prior to report, the patient had a re-adjustment programmed for tightness of his tongue and left side tremor and the settings were reprogrammed back to 2013. The left side voltage was changed from 3. 5v to 3. 4v and the right side from 4. 3v to 4. 1v. The patient felt a little improvement with his tongue tightness. There was no falls or trauma and no x-ray was performed. Additional information received reported there was not a 50% or greater symptom reduction and the cause of the event was not determined. While reprogramming was done, the patient had severe parkinson¿s symptoms of tremor, bradykinesia, and they couldn¿t talk on 2014 (b)(6). The loss of therapeutic effect and the loss of stimulation were sudden. The patient was admitted to the medical center on 2014 (b)(6) and was discharged on 2014 (b)(6). The patient died 7 days after being discharged and it was unknown if the death was device related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4303983
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dennis100
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« Reply #62 on: March 07, 2015, 03:52:46 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had their deep brain stimulator installed in 2012 and after discovering an exposed wire had the present unit installed on (b)(6) 2013. The patient¿s neck had been bothering him for a couple of months so the healthcare professional had checked it and discovered the wire was exposed. The exposed wire was discovered 8 months after implant. A replacement was done on (b)(6) 2013. They had to rewire everything and the healthcare professional was playing it safe because they were afraid there might be an infection. No infection was reported that was just the reasoning for doing everything except the leads. The patient¿s last visit to the healthcare professional was on (b)(6) 2013 and they had not followed up with the patient since the event. The patient had not had concerns with their device or therapy.

Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4526333
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dennis100
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« Reply #63 on: April 19, 2015, 02:31:50 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that six months prior to this report the patient had a revision surgery to correct a ¿bowstring cord¿ problem in their neck. The implantable neurostimulator (ins) was initially implanted in the patient¿s chest and the revision was done to relocate the ins to the abdomen and add two extensions. For the past two months the problem had reoccurred and appeared to be worse than before. The patient had a loss of therapeutic effect, their therapy was in decline, and they were not getting any therapy benefit. At the time of this report the ins was on and the patient had not had any falls or trauma. The wires in the patient¿s neck were pulling and tugging again and they had become very tight. The patient stated it felt like the wire shifted and was pulling in the same area of the neck again. The patient had pain in their shoulder, chest, and neck especially after waking in the morning. The patient¿s pain and discomfort was moderate, but it was increasing on the side where the wire was running to the ins. The patient had been stretching their neck and that seemed to help take the strain off of the cord a little, but it was very painful to do it. The patient stated they had no idea if they were damaging the cord, units, or implants while stretching their neck. The patient had noticed indentations in their head and a bulge where one of the caps and wires was coming loose from the skull. The patient noticed they had swelling in their chest where the old ins and there was a bunching of wire in their abdomen by the ins. The patient had lost 10-15 pounds and they stated that may account for the noticeable signs in their head and stomach. Overall the ins was doing its job and functioned well and the patient felt the benefits outweighed the negatives. The patient¿s healthcare professional (hcp) did not see anything concerning and they thought the scarring around the extension was contributing to the discomfort. The patient¿s main concern was that if the wire continued to stretch, would it cause problems with the vein or artery that crossed their neck or would it pull on the leads in their brain. Almost two weeks later, the patient reported that their ins was not working correctly and there appeared to be a partial or total failure. The patient programmer was not picking up anything and the recharger was sporadic at picking up a signal. The patient was not sure if this was related to the extreme pulling in their neck or the bunching of wires in their abdomen near the ins. The patient was not feeling as much of the benefits and they were concerned that a wire might be loose and the programmer was inoperable. The patient was not able to turn the ins off since the programmer was not recognizing or reading the ins and it did not show any signs of an ins being present. The recharger had been able to connect to the ins just fine at times and had shown the ins was charging and functioning. The patient knew the ins was on as they were feeling some benefit. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0gh58, implanted: (b)(6) 2014, product type: lead. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014,product type: extension. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4596445
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dennis100
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« Reply #64 on: April 19, 2015, 02:32:36 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the lead wire was rigid and it caused the patient¿s neck to be sore and stiff. There was pain in the neck at the extension location. It had been progressively getting worse since (b)(6) 2014 when the patient had gotten the implant. The patient¿s extensions were too tight. There was a lead/extension issue, it was too tight from the lead connection down to the clavicle. No action was required as a result of the event. In (b)(6) 2015 the healthcare professional had done a revision, they had gone in to pull the lead wire up and they had pulled some of the extension wires up in the neck to see if that would loosen the wires to give the patient more slack or loosen the wires, but that had not worked and the patient had a bundle of lead wire protruding under the skin above the clavicle. The patient had a buckled wire around the clavicle. The patient was very thin so he scared easily. The patient had stated that the design for a lead that would not cause scar tissue should be a ¿requirement. ¿ the healthcare professional had told the patient that because he was very thin and had little subcutaneous fat the wires had not ¿skude¿ under the skin as well. The healthcare professional also told the patient that the manufacturer needed to coat the extension with nano technology in order to fix the problem. The current extension wire formed scarring which lead to pulling and pain in the neck. Patients with a lot of fat had not experienced the issue but others do. This was becoming a common problem. The cause of the event was determine and was device related. The healthcare professional thought the coating applied to the wire, all of the wires got scarring then tended to cause pulling unless the patient had a lot of fat which acted as a lubricant. The patient had not recovered, symptoms/issue was ongoing. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0hyjm, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4613200
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dennis100
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« Reply #65 on: May 09, 2015, 02:18:27 AM »

Model Number 37601
Event Date 06/24/2013
Event Type Injury
Event Description
It was reported that the patient experienced redness at the left frontal incision without ¿drain. ¿ corrective action included medication added, discontinued or dose change. The medication was bactrim. The event was reported as resolved. The patient also experienced neck discomfort due to pulling of the extension. Corrective action was noted as ¿other¿ and the event was not resolved.

Manufacturer Narrative
Concomitant products: product id: 3387, lot# unknown, product type: lead. Product id: 3387, lot# unknown, product type: lead. Product id: neu_unknown_ext, lot# serial# unknown, product type: extension. Product id: neu_unknown_ext, lot# serial# unknown, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4657287
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dennis100
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« Reply #66 on: May 09, 2015, 02:19:19 AM »

Model Number 37612
Event Date 03/25/2015
Event Type Injury
Event Description
It was reported that the patient¿s neurologist called the manufacturer representative (rep) and asked which x-rays would provide the best image of the implantable neurostimulator (ins), extensions, and leads. The patient self-admitted to the emergency room (er) the morning of the report; he had pain on the right side of the neck and a return of symptoms, including speech degradation and a change in gait. It was considered a sudden loss of stimulation and therapeutic effect. The ins was checked by the neurologist using a clinician programmer and it appeared to be on without any problems. The patient was hospitalized due to the event and was referred back to the original implanting physician for evaluation. No surgical interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 64002, lot # n248030, implanted: (b)(6) 2010, product type adapter; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4693815
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dennis100
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« Reply #67 on: June 08, 2015, 06:05:30 AM »

Model Number 37601
Event Date 04/05/2015
Event Type Injury
Event Description
Additional information received reported that the patient experienced an intracranial infection in the right frontal lobe.

Manufacturer Narrative

Event Description
It was reported that there was intracranial infection. The patient presented to the er with altered mental status, severe head and neck pain, and feeling like his insides were melting. The patient experienced in-patient hospitalization and an emergency room visit. Other surgical intervention was conducted including complete removal of bilateral electrode systems and generator. Perioperative antibiotics were administered specifically kefzol. The patient did not have meningitis. An organism culture showed staphylococcus aureus from the wound. Medication were administered specifically iv vancomycin and iv nafcillin on (b)(6) 2015. The outcome was noted as resolved without sequelae.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# va0qxld, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 3387s-40, lot# va0nplb, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4760034
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dennis100
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« Reply #68 on: June 08, 2015, 06:06:18 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported the patient had chest pain, a loss of effect, and a lack of symptom control since the replacement of their implantable neurostimulators (ins). The patient had been having slurred speech and issues with controlling their tongue. On the day prior to this report, the patient had bit their tongue bad, which had made their speech even worse. The patient¿s jaw was tight and they almost broke a tooth. Every time the patient had their ins replaced, it took them three months to get the ins properly adjusted and for them to receive any benefit. The patient also had an increase in rigidity and dystonia in their neck and extremities with their left being worse than the right. The patient met with their healthcare professional (hcp) a day prior to this report because their pain was so bad they thought they were having a heart attack. The pain was located in the patient¿s chest near the ins and in their armpits. An x-ray was done and the patient was going to follow up with their cardiologist. The patient was evaluated by their cardiologist and cardiac etiology was ruled out. Impedances were checked and one of the contacts was not being used. Impedances of electrode zero were measured to be greater than 40,000 ohms on the left side. The left ins was programmed to 2-, 3+ at 4. 7v, 90 usec, and 145 hz. Impedances of electrode three were measured to be greater than 40 ,000 ohms on the right side. The right ins was programmed to 1+, 2- at 4. 2v, 90 usec, and 145 hz. Therapy impedances were measured to be within normal limits on both sides. The patient¿s hcp planned on reprogramming the ins to get efficacy. The cause of the event was not determined. A troubleshooting revision had been scheduled for (b)(6) 2015 due to the high impedances. During the revision, the hcp opened the right incision and noticed the bottom two screws on the ins were not tightened. The hcp loosened all four screws, dried off the extension, and retightened everything. The right side bottom connector for the ins and extension still seemed not tight and there was a small gap, but everything was tightened down. Impedances were then tested and all impedances were within normal limits. The same issue occurred when the left side incision was opened. After the revision, all impedances were within normal limits on both sides and no further troubleshooting was done. Refer to manufacturer report #3004209178-2015-09832.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v443426, implanted: (b)(6) 2010, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802318
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« Reply #69 on: July 15, 2015, 10:36:57 PM »

Model Number 3387S-40
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot# va0ery5, implanted: (b)(6) 2014, product type lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type extension. (b)(4).

Event Description
It was reported that there were wires left in the patient¿s brain because the healthcare professional had been afraid to remove them from the brain and it was causing the patient to not be able to breath correctly which was why he needed a continuous positive airway pressure (cpap) machine. The patient had very bad headaches. The patient¿s leads had started to make his head hurt. The leads gave the patient headaches that made migraines feel like nothing. The patient could feel the wire on the left side of his neck and stated that it was a long wire and the wire on the right was not as long as the wire on the left. The patient would get pain that started on the left side of the neck and then the pain spread to the right side of the neck and hits the forehead from temple to temple and then the pain attacked the eye so he would have to put on dark glass. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 6000153-2015-00119.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4865089
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« Reply #70 on: July 15, 2015, 10:37:53 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient complained of the bowstring effect and pulling in their neck when meeting with their healthcare professional (hcp) due to the implantable neurostimulator (ins) reaching elective replacement indicator (eri). The ins reaching eri was considered normal. Impedance testing was done and the cause of the event was determined to be the bowstring effect in the patient¿s neck. The hcp decided to replace both extensions. Following the revision, the issue was resolved.

Manufacturer Narrative
Concomitant medical products: product id: 37085-60, serial# (b)(4), implanted: 2009-(b)(6), explanted: 2015-(b)(6), product type: extension. Product id: 37085-60, serial# (b)(4), implanted: 2009-(b)(6), explanted: 2015-(b)(6), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# v279269, implanted: 2009-(b)(6), product type: lead. Product id: 3389s-40, lot# v285199, implanted: 2009-(b)(6), product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4862317
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« Reply #71 on: July 15, 2015, 10:39:32 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the last few weeks had been terrible for the patient. She fell several times and had to go to the emergency room (er) to determine if her kneecap was fractured. Her mental state was deteriorating rapidly, as she cried for the better part of a day because of frustration in not being able to walk ten feet without falling down. Her leg strength was completely gone and simply would not support her body. The patient also had significant pain in her neck that never seemed to diminish. Her right side was not functional and she had developed restless leg, which would not allow her to sleep for any length of time. She could barely perform the basic functions to care for herself. Her emotions were running sky high and the reporter¿s fear was that she was in so much agony that she may harm herself in a fit of anger. The patient had minimal trouble walking before implant, but could hardly walk at the time of the report. She was at the two month mark post-surgery and had seen little improvement in her condition. Her overall condition was significantly worse at the time of the report than prior to implant. The only caution presented prior to surgery was that her iq might drop a few points. The reporter felt this was an understatement as the patient was actually acting ¿like an eight year old. ¿ the reporter questioned her overall competency. Adjustments to the device had yielded little improvement. The patient could not go on like this much longer as her health was deteriorating rapidly. Follow-up from the manufacturer representative (rep) reported that there was 50% or greater symptom reduction. The patient had three programming sessions and had a follow-up appointment scheduled with her doctor for (b)(6) 2015. It was unknown how the patient was doing, but the therapy was being delivered. The patient had not had her appointment with her doctor yet, so additional information will be requested at a later date. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant product/(s): product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642,serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841044
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« Reply #72 on: September 07, 2015, 07:51:33 AM »

Model Number 37612
Event Date 07/15/2015
Event Type Injury
Event Description
A consumer reported via a manufacturing representative that since (b)(6) 2015 the patient's neck muscle was rigid. No troubleshooting was done and the cause of the event was not determined. Reprogramming was done on (b)(6) 2015 and the patient's health care provider (hcp) determined the event was due to a short wire. There was no improvement in symptoms and the hcp suggested replacement.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5017767
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