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Author Topic: Deep brain stimulator - Legs  (Read 42541 times)
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dennis100
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« Reply #90 on: January 10, 2015, 11:33:57 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that ¿efficiency was not good¿ after the device was implanted; the patient still had dyskinesia symptoms. Every time seasons changed, the patient experienced pain in their head and chest area where the implant was. Due to the ¿poor efficiency¿, the patient¿s mood was ¿not stable¿ and she wanted to commit suicide in (b)(6). Reprogramming was attempted then, but the dyskinesia didn¿t get better, and in (b)(6), got worse. Reprogramming was again attempted early november and the dyskinesia got better but the patient¿s ¿active was stiff¿ due to the changed stimulation mode. Three days later, the patient¿s legs felt weak, and she additionally felt cold and sick. Sinemet and madopar were taken, and the symptoms got better. Four days after that, the patient went for a ¿blood check¿ and the healthcare provider indicated the patient ¿didn¿t get cold¿. Subsequently, the patient¿s whole body felt weak again, and she felt cold and sick. Reprogramming was again attempted approximately a week later, and after increasing ¿the parameter¿, "the symptom" was controlled. The patient was doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4294422
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dennis100
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« Reply #91 on: February 07, 2015, 06:57:56 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3387-40, lot # j0437239v, implanted: (b)(6) 2004, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 3387-40, lot # j0437239v, implanted: (b)(6) 2004, product type lead; product id 37601, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension. (b)(4).

Event Description
It was reported the patient had their annual checkup last friday and they brought their patient programmer with them because they could not get the programmer to do anything. The patient changed the batteries in the programmer and they could still not get it to do anything. The patient tried alkaline batteries, but the issue did not resolve. The patient¿s healthcare professional (hcp) checked the programmer and they said it was ¿kaput. ¿ the problem with the programmer started recently. The patient¿s legs started hurting with continual pain about two weeks prior to this report and when they tried using the programmer to increase stimulation to cover the pain, they were not able to since the programmer would not power on. The patient stated they had deep brain stimulation for pain due to multiple back surgeries. The patient¿s pain was controlled to some extent and stimulation covered about 50 percent of their pain. The rest of the patient¿s pain was controlled with oxycontin. The patient¿s left implant controls their endorphins and th eir right implant was for pain. The hcp stated the implantable neurostimulator (ins) on the left side was dead and that ins had been implanted for ten years. The patient stated their hcp was concerned about the left ins that controls the patient¿s endorphins because that ins was dead. Upon device return, analysis of the patient programmer found the telemetry board was corroded and the antenna jack was resoldered as a preventative measure, c300. Additional information received reported the stimulator on the left side that controlled the endorphins had never been replaced. In november prior to the date of this report when the patient had last visited his healthcare professional he was told that the left side stimulator was dead. The patient had been scheduled to have both sides replaced in (b)(6) 2015. It was noted that from what the patient was able to gather they had planned to only replace the right side stimulator for pain which lead him to believe that the stimulator for the endorphins had not been functional so it would not be replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4416070
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dennis100
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« Reply #92 on: February 07, 2015, 06:58:43 AM »

Model Number 37601
Event Date 12/18/2014
Event Type Malfunction
Event Description
It was reported the patient saw their healthcare professional (hcp) for an adjustment the day prior to this report and they could hardly walk after. The patient stated the hcp was trying to adjust them, but they made them worse and they were walking like they were drunk. The hcp adjusted the patient back to the original settings, but the patient was still messed up. The patient wanted to lower both sides, but they could not. Every time the patient¿s setting went up they felt pins and needles running down their legs. The pins and needles had been going on since implant a month or so prior to this report. The patient¿s left side was at 1. 50v and the right side was 1. 50v. The patient stated one of them went down to 1. 10v, but then it popped back up and they could not lower it. The patient wanted to lower the settings on both sides so the feeling would go away. A lower limit screen was reached when the patient tried to lower the left side. The patient thought they were able to lower the left side before. The patient was able to lower the right side to 1. 10v. 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 37642, serial# (b)(4), product type: programmer, patient; product id 7 482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3387s-40, lot# v281324, implanted: (b)(6) 2009, product type: lead; product id 3387s-40, lot# v268107, implanted: (b)(6) 2009, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 64002, lot# n450589, implanted: (b)(6) 2014, product type: adapter. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4399221
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dennis100
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« Reply #93 on: February 07, 2015, 12:03:33 PM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking or jolting sensation. Since the patient¿s implantable neurostimulator (ins) was replaced in (b)(6) 2013 the patient had experienced significant shocks every time the ins was turned off with the patient programmer or during reprogramming. The healthcare professional (hcp) observed the shocks the day prior to this report when they were reprogramming the patient. The hcp stated the shocks were severe and lasted less than a couple seconds. The shocks were more severe when the ins was turned on. The patient felt the shocks on the left side of their face, arm, and leg. The hdp did not decrease stimulation before turn the ins off because it happened during reprogramming when they were changing the electrode configuration and the amplitude automatically dropped down to zero. The patient felt the shocks when the stimulation was at 0. 0v. The hcp stated that impedances may have been a little on the low side around 700-800 ohms, but nothing out of range. The patient was programmed at c+, 1- at 3. 5v, pulse width of 90, and a rate of 130 hz. The patient had previously been programmed at 4. 0v and a pulse width of 90. The ins was not programmed using interleaving and the ins was in voltage mode. Bipolar programming had not been tried. 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 3387s-40, lot# v311441, implanted: (b)(6) 2010, product type: lead; product id 37642, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4393408
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dennis100
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« Reply #94 on: February 07, 2015, 12:04:10 PM »

Model Number 37601
Event Type Malfunction
Event Description
It was reported that the patient had the device implanted on (b)(6) 2014 for parkinson¿s and the patient believed the right side was disconnected. The patient had a return of tremors on the left side, he could not walk and kept falling. It was noted that when the patient was taking a shower he had rubbed his head kind of hard and scratched it a little and when he pressed down on his head he could feel tingling in his feet and legs on the left side. This had all begun 3-4 days prior to the date of this report. The patient had called and scheduled an appointment for (b)(6) 2014. No intervention or 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 3389s-40, lot# va0d7cw, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead; product id 3708660, 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). (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4388049
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dennis100
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« Reply #95 on: March 07, 2015, 04:50:46 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va0mlnr, implanted: (b)(6) 2014, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va0mqlu, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported that after implant the patient had the flu, a bladder infection, and then trouble breathing. The deep brain stimulation was not helping as the patient expected and they never had therapeutic effect. The patient stated they were in worse shape now than before the surgery. The patient had concerns with freezing and trouble walking. About two weeks prior to this report they went down to their knees due to trouble walking. The patient stated that they saw somewhere that deep brain stimulation was not for freezing or walking. Since implant the patient had developed bladder control issues at night. The patient has macular degeneration and since implant their eye healthcare professional (hcp) told them they had developed ¿a jelly type thing behind their eye that was putting pressure on their eyes. ¿ the eye hcp was not sure if it was related to deep brain stimulation or not. After the stage one and two implants the patient had a stent in the left leg implanted and a vein closed in their right leg. Reprogramming had been done twice and the patient¿s last appointment with their hcp was on (b)(6) 2015. The patient¿s next appointment was scheduled for (b)(6) 2015. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4480167
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dennis100
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« Reply #96 on: March 07, 2015, 04:51:33 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that during the call the patient had seemed confused. The patient and his wife were having a ¿rough time¿ and he had device turned on the morning of the date of this report for the first time. The patient had come into possession of the controller and read though the handbook. The patient was having some delirium in the midst of dyskinesia episode. Several implantable neurostimulator (ins) checks were done and showed the ins was fully charged/brand new and should provide a good service life. The patient was in agony, his pain level had gone up since the unit had been installed. The patient had pain in his right and left leg which had started about a year prior to the date of this report. The patient had parkinson¿s but had not had a tremor, he had a tightening of the muscles in his thighs and that caused pain and it had been developing over a couple of years and that was the reason for the deep brain stimulator system to control his pain. The patient thought his wife was causing his pain but the only thing she could do was shut the device off. The patient had left the healthcare professionals at noon on the date of this report and they were thrilled because his pain was better then he had taken his noon dose of sinemet and started having extreme dyskinesia where he had kind of gone into an altered state and his pain was unbearable, it was impossible to really know. The patient was due for his 3 pm sinemet dose, the patient had expressed concern for double dose and the patient¿s wife confirmed the healthcare professional had given them instructions to continue regular medication dose. They were going to discuss the first 24 hours on the day following the date of this report with their healthcare professional and they would decide if the patient can cut back on medications or leave them as is for a while. It was stated that ¿yes you are having more effect because your medications are the same and now you have the stimulation on top of that causing you to have dyskinesia worse than usual. ¿ 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: 3389s-40, lot# va0nesh, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4503250
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dennis100
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« Reply #97 on: March 07, 2015, 04:52:22 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had the following symptoms: altered mental status, burning sensation, change in gait, difficulty walking, leg dragging and swelling. The patient¿s stimulation had to be turned up pretty high in order to control his tremor. Sometimes when it was so high he had a burning sensation in his face. When stimulation was turned off he still felt the burning sensation and he wanted to know if this was normal and if it was possible that it could cause permanent damage. When stimulation was turned off it took a couple of days for the burning to stop. The burning in the patient¿s face had started sometime in early to mid-(b)(6) 2014. There was a spot right about his lip that took longer to have the burning go away and sometimes it would take about a month before the burning stopped. The patient had two leads, one on the right and one on the left that were both connected to an one implantable neurostimulator (ins) which was in his left chest. The patient was told that in order to help with the progressive tremor and the burning in his face they would need to implant a 3rd lead and another ins in the other side chest and the patient was inquiring if this was normal. The patient¿s tremor was progressing and he was able to tell weekly because the tremor was moving and increasing. The patient¿s left hand was getting worse and he gait was also changing. Sometimes the patient had voice trouble, with tremor in his voice and sporadically he had uncontrollable tremor with his head and eye lids. The stimulation had worked at controlling his symptoms for a few months but the tremor had been gradually increasing so the patient was unsure if it was a stimulation issue or a symptom issue. Amplitude was set at 1. 3 volts on the right side of the brain. The patient had a fall a couple of weeks prior to the date of this report, the patient stated that he had many ¿almost falls¿ but the last one was a couple of weeks prior to the date of this report. It was noted that it had been a nightmare since day one. The patient stated that when the leads were put in the brain he had an edema of the brain and they were not sure what the swelling was from but the patient had brain damage from the swelling. After the implant they had brain swelling. The patient had blood clots from being down for so long. Also, the patient was unable to use the right side of his body for a few days after the surgery. The patient zoned out, the nurse would bring the patient into a dark room and he would not be able to figure out what he was supposed to do until he was directed to turn on the light. The patient had stated that it was like he knew what to do but would get stuck in between what he should do and how to do it. On occasion he would have to use the left hand to move the right hand and also he would want to use his right hand but he wouldn¿t know how to use it. The patient was able to walk normal but sometimes his leg would drag. Most of the time it was the left leg that would drag but it would also be the right as well but the left was worse. Following implant of the leads the patient was already having problems before he even got home. It was so bad that his wife brought him to the emergency room. It was noted that while at the emergency room the patient was so thirsty, he got up and walked over to the faucet; he could hear the water gurgling in the pipes but forgot to turn on the water so he was trying to suck the water out of the faucet. The patient would drift in and out of reality. The patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative. The patient had an appointment scheduled but the date was illegible. No outcome or intervention was reported. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515835
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dennis100
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« Reply #98 on: April 19, 2015, 02:29:48 AM »

Model Number NEU_UNKNOWN_LEAD
Event Date 03/02/2015
Event Type Injury
Event Description
It was reported there was a subdural hygroma without mass effect. The patient had bilateral leads placed and the stimulator was scheduled to be placed later in (b)(6) 2015. The patient experienced a headache with bilateral leg weakness. The patient was observed in emergency department overnight. A ct scan with contrast revealed a small amount of extra axial fluid of simple density overlying the vertex. It was likely a subdural hygroma without mass effect. The etiology was the surgery/anesthesia and was unlikely related to the device or therapy and possibly related to the implant procedure. The event resulted in in-patient hospitalization. Refer to manufacturer report # 3007566237-2015-00790 the patient is implanted with bilateral leads.

Manufacturer Narrative
Concomitant: product id neu_unknown_lead, implanted: 2015-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638119
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dennis100
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« Reply #99 on: April 19, 2015, 02:30:26 AM »

Model Number 37601
Event Date 01/24/2014
Event Type Injury
Manufacturer Narrative
Concomitant: product id neu_unknown_lead, product type lead. (b)(4).

Event Description
It was reported that the patient experienced shaking in the hands, rigidity in the legs, and a lisp after an implantable neurostimulator (ins) replacement on 2014-(b)(6). In (b)(6) 2014, the patient took mri films to a new physician who indicated the target location of the lead was ¿not accurate¿ and a second surgery was recommended. The patient¿s implanting physician believed there wasn¿t a problem with the target position. The patient wants to have a second surgery but no date for the surgery had been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4637974
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dennis100
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« Reply #100 on: May 09, 2015, 02:07:58 AM »

Model Number 37601
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id 3387, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

Event Description
It was reported that the patient experienced myoclonic jerks of arms and legs. Corrective actions included medication added, discontinued or dose changed. Depakote was started after lab work was reviewed on (b)(6) 2014. The event was not resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4662492
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dennis100
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« Reply #101 on: June 08, 2015, 06:02:11 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the essential tremor patient experienced ¿shocking sensations and paresthesias¿ in his left arm, torso, and leg with the sensations ¿not limited to a specific location. ¿ the patient reportedly ¿could induce the sensation when pressing onto the implantable neurostimulator (ins),¿ however sometimes the shocking sensations would also occur ¿without any external influence. ¿ the patient additionally experienced ¿intermittent stimulation,¿ whereby the patient¿s tremors ¿reoccurred regularly, as if the ins was turned off. ¿ it was stated the patient experienced ¿less than 50% therapy relief¿ on his left side. These tremors would occur ¿sometimes for several hours. ¿ the tremor would then ¿disappear on its own later, as if the stimulation was turned back on. ¿ it was noted the patient lost his paresthesia and therapy within 24 hours of having his ins interrogated with a physician programmer at the time of report. Impedance testing was performed and found ¿fine¿ impedance values. X-ray imaging ¿didn¿t show any anomalies in the extensions/leads. ¿ the patient¿s stimulation was reprogrammed to a bipolar stimulation setting in an attempt at troubleshooting the situation; however, it was noted that ¿even with the bipolar stimulation there was a shocking sensation when touching the ins. ¿ the patient¿s ¿stimulation was still intermittent¿ and a revision surgery was planned for the patient as of 16 days after initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743368
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dennis100
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« Reply #102 on: June 08, 2015, 06:02:54 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that the patient was feeling stimulation on the night prior to the date of this report but the patient¿s wife was worried that the patient¿s battery had gone dead since he could no longer move his legs like before and he was not feeling good. There were no falls or accidents. The last successful recharging session was a few days prior to the date of this report. Additional information received reported that it was unknown if the recharging frequency had matched the patient¿s settings. It was unknown if patient was trained and able to demonstrate effective recharging. The patient was in continuous mode. The cause of the event was determined and was device related. The patient had undergone a replacement. The rechargeable device was overstimulated even though settings were the same. It was unknown if the patient was recharging normally and if the patient was receiving effective therapy. The patient had been evaluated by neurosurgery and was reprogrammed on (b)(4) 2015. Patient status was unknown.

Manufacturer Narrative
Concomitant medical product: product id: 3389s-40, lot# v012773, implanted: (b)(6) 2007, product type: lead. Product id: 3389s-40, lot# v012773, implanted: (b)(6) 2007, product type: lead. Product id: 37092, lot# 328720001, implanted: (b)(6) 2012, product type accessory product id: 37651, lot# serial# (b)(4), product type: recharger. Product id: 64002, lot# n340417, implanted: (b)(6) 2012, product type: adapter. Product id: 748251, serial# (b)(4) implanted:(b)(4) 2007, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4804800
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« Reply #103 on: June 08, 2015, 06:03:45 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 #104 on: July 15, 2015, 11:25:09 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 #105 on: July 15, 2015, 11:26:08 PM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s lead extension started to slide down his skull soon after implant. Eventually it slid off of his skull. Skin erosion was also reported. This was followed by decreased benefit. It was also reported that when the patient was on vacation he felt his device turning on and off. He felt tingling in his arm and leg like when the device was turned on/ off. The patient¿s implant was revised and replaced in 2013. The extension was removed but the lead remained implanted. No outcomes 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4813073
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dennis100
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« Reply #106 on: July 15, 2015, 11:27:19 PM »

Model Number 37602
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient had pain in her leg since 2013. The tens unit that the patient had was recommended for her leg and ankles. Information about ankle wounds that the patient had received continual wound care for was omitted due to the fact that it was unrelated. The patient had a loss of therapeutic effect and experienced a return of shaking that had occurred since august 2014. An eos/eol message was reported on 2015 (b)(6). The implantable neuro stimulator (ins) was checked yesterday, however, it was unknown when the last time the ins was checked using the programmer so it was unknown when the ins initially reached eri. It was recommended that the ins be replaced but the patient didn¿t want it replaced. The patient was to be scheduled for a battery replacement. It was unknown if the patient had a 50% or greater symptom reduction. Patient status remained unknown as the patient was ¿lost to follow-up and was last seen in 2010. " further follow-up is being conducted to obtain information. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4827854
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dennis100
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« Reply #107 on: August 08, 2015, 08:27:36 AM »

Model Number 37612
Event Date 04/14/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the parkinson¿s disease patient experienced ¿symptoms or leg tremor and dyskinesia. ¿ these symptoms were reported to have appeared since a month prior to report and they did not improve following reprogramming during the month prior to report. The cause of the issue was not determined and the patient remained with leg tremors and dyskinesia during that time. Additional information reported the patient experienced the appearance of inarticulacy on (b)(6) 2015. The patient¿s physician increased their stimulation to 1. 95 volts as a result; however, there was ¿no improvement. ¿ additional information has been requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4915123
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« Reply #108 on: August 08, 2015, 08:28:20 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v333260, implanted: (b)(6) 2009, product type lead; product id 3389s-40, lot # v276341, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

Event Description
It was reported there was a loss of therapeutic effect. The patient was falling. He used to fall before having the implantable neurostimulator (ins) but now he was starting to fall again. They fell 2-3 times two days prior to report and went to the er at midnight. The patient fell again several times the day prior to report and went to the er again at 10pm. While the patient was in the er they had a ct scan on the head. The ct scan that was done in the emergency room was negative. He also fell several times while on vacation for 2 months in (b)(6) 2015. The patient was trying to walk and he had been freezing in his legs. They had told him to move his legs and he couldn¿t. It was noted that this was something the patient had previously to the ins. The falls had been getting worse and because of the falls, he had torn his left shoulder out of the pocket and he has to get his left shoulder fixed. His legs were deteriorating and he doesn¿t have strength in his legs. Additional information received 3 days later reported there was not a 50% or greater symptom reduction. The cause of the event was not determined and it was unknown if it was device related. It was unknown if reprogramming was needed. The patient wondered if a ¿wire came loose with falls. ¿ the patient was going to be hospitalized on (b)(6) 2015 and they would check for wire fracture. They would have an upcoming admission to the hospital for medication adjustment. The patient had not yet recovered and they were in physical therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4898863
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dennis100
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« Reply #109 on: August 08, 2015, 08:29:06 AM »

Model Number 37612
Event Date 06/20/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that on (b)(6) 2015, the patient became inarticulate and had leg muscle stiffness. Reprogramming was done in (b)(6) 2015 and the patient¿s healthcare professional (hcp) turned stimulation up to 2. 5v from 2. 0v, but there was no symptom improvement. The cause of the event was not determined. The patient wanted to know if there are any better solutions. No interventions or outcome were reported regarding this event. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949605
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dennis100
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« Reply #110 on: September 07, 2015, 07:43:44 AM »

Model Number 37603
Device Problem Communication or transmission issue
Event Date 07/21/2015
Event Type Malfunction
Manufacturer Narrative
Product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead. (b)(4).

Event Description
A consumer reported that a poor communication screen was displayed on the patient programmer and the patient was getting poor communication. The patient was recently implanted and bandages and some swelling was present. On the day of this report, the patient met with a nurse for their health care provider and they turned down settings a little bit. Since the settings were turned down, the patient's hand was shaking really bad and the shaking was terrible. The shaking had started the day prior to this report and had gone away, but it was back today. The patient only had shaking in their hand and it was gradually getting worse. On 2015 (b)(6), the patient had cramping in their leg. The patient's indication for use is essential tremor and movement disorders. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5010764
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« Reply #111 on: September 07, 2015, 07:44:29 AM »

Model Number 37602
Event Date 07/11/2015
Event Type Injury
Event Description
It was reported the patient was admitted to the emergency room due to a loss of therapeutic benefit. The patient first noticed the loss of deep brain stimulation (dbs) benefit last night and today, the patient¿s arms and legs were moving wildly. The patient was brought to the emergency room by ambulance. Both of the patient¿s implantable neurostimulators (ins) were checked using the patient programmer and they were both on and at 3. 4v. Impedances were not checked. The patient indicated that prior to being taken to the emergency room, a nurse at their assisted living center may have made changes to their therapy, but they did not know what changes were made. The last reprogramming session was 3-4 months ago. The patient had no falls or trauma and had not been had any recent medical tests or environmental exposure. The reporter wanted to know if a manufacturing representative could check the inss. 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 products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389-40, lot# v000631, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient. Product id: 3389-40, lot# j0537580v, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4961817
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« Reply #112 on: September 19, 2015, 02:39:40 AM »

Model Number 7428
Event Date 08/11/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The consumer via a manufacturer representative reported that the patient was implanted on (b)(6) 2013 due to parkinson's disease. On (b)(6) 2015, the patient's limbs felt rigid and it was difficult for them to walk. The patient suspected that the implantable neurostimulator (ins) was shut down. The patient requested a reprogramming on (b)(6) 2015. No troubleshooting was done and the event cause was not determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5043176
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dennis100
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« Reply #113 on: September 19, 2015, 02:40:56 AM »

Model Number 37612
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 37651, serial # (b)(4), product type recharger; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension. (b)(4).

Event Description
A consumer reported that the patient whose indication for use was parkinson¿s dual and movement disorders had had a fall on (b)(6) 2015 and broke two fingers on the right hand and starting on (b)(6) 2014 the patient had a loss of stimulation and a return of shaking. The shaking the patient was experiencing was in both legs and the right hand. It was unknown what the patient was doing when they had lost therapy. The device was checked with the patient programmer and stimulation was on. The patient does not have the ability to adjust stimulation. Follow-up is being conducted to obtain information about troubleshooting done. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5042386
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