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Author Topic: Deep brain stimulator - Walking/Gait  (Read 91615 times)
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dennis100
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« Reply #150 on: September 06, 2014, 02:02:43 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Event Description
It was reported that the patient had had balance issues and trouble with speech since implant. It was noted that the patient had fallen a couple of times. Initially it was thought that the patient¿s medication was off but he had been off the medication and was still having problems. Patient had been instructed to turn stimulation down and had further programming appointment scheduled for the friday following the date of this report. Patient¿s stimulation was down from 3. 30 and 4. 10 to 3. 0 and 3. 40. Patient¿s status was unknown. It was later reported that there was disappointment and dissatisfaction expressed about the therapy as far as what had been sold and presented to them prior to implant and what had happened in reality. Patient had tremors prior to the deep brain stimulator implant. Patient had been pretested and it had worked for him. Almost 2 months after implant the patient had a lot of issues. Patient¿s quality of life had not increased. Patient had an appointment scheduled for (b)(6) 2014. Patient was experiencing symptoms. It was noted that the patient had expected it to be an outpatient surgery and instead patient had spent 10 days in rehab. The patient had been told about the risk of infection and stroke but nothing else. The patient had been trained on using the patient programmer but did not know what to do with it. The patient was not very discouraged and not positive. The patient was not enjoying things in life anymore. It was noted that prior to deep brain stimulator surgery the patient had only had some tremors and had not been that advanced with parkinson¿s disease symptoms. The deep brain stimulator surgery was supposed to make the patient better but had made him worse. Patient was not able to return to his physical job. Patient¿s symptoms were change in gait, lethargy, and seizures. It was further noted that the manufacturing representative had been there when the patient had a seizure and the representative had come to rehab. The patient had had a seizure right after surgery at the hospital on the date of implant. At rehab the patient had been completely out of it and had been unresponsive. The healthcare professionals were blaming it on medications. Patient was put on 4 different seizure medications, one being dilantin. Patient no longer took seizure medication. Patient was unresponsive and was sent for a computerized tomography scan (cat scan) which had determined the patient had seizures and that was when patient was put on seizure medications. The healthcare professionals had stated ¿oh no, he should be responsive. ¿ it was noted that nobody seemed to know what was going on. They had come for physical therapy and were not able to wake him up, he had been completely out of it. An electroencephalogram (eeg) was done and had not found anything particular. Following deep brain stimulator surgery patient had the following symptoms: speech issues, gait issues, balance problems, patient had fallen several times, extremely tired, swallowing issues, patient looked at food as if he did not know how to put a fork into it, and patient looked like he had aged (b)(6). Patient used to work full time, go to ymca 3 times a week and drove a car, patient was no longer able to drive or do anything. It was hard to leave the patient alone. It was believed that symptoms were device related because patient had no chemicals in his body except some medication for parkinson¿s and it was not a lot. Healthcare professionals stated they had never seen those symptoms after a deep brain stimulator surgery. Patient was told that this kind of reaction was very common and it might take 6 months to a year to recover from the surgery. Patient had been given a limit on the patient programmer and could not go beyond ¿4 or something. ¿ patient had been adjusting therapy all the time on his own. Patient got better here and there but still had a lot of issues going on and was no longer positive. Patient was scheduled to see the healthcare professional on friday following the date of this report. Additional information received reported the patient was having some gait and speech issues related to programming. Patient had primary tremor with parkinson¿s and as the patient would get tremor control he would get some speech issues. The patient had since been reprogrammed to a bipolar setting and although he had a little bit of a breakthrough tremor his balance was better and so was his speech the last time the manufacturing representative had spoken to the patient. It was unknown if there were any other updates. The manufacturing representative had been involved with the patient through rehab. It was noted that the patient¿s family was anxious about getting the patient¿s progress and getting him programmed so he could go back to work. As of the week prior to the date of this report the patient was doing better and was planning on returning to work. Additional information received reported the alleged seizure was not the reason for rehab and all of their patient¿s go through a rehab cycle. Seizure was not confirmed and had been discussed after the fact. The patient was having some cognitive issues after the battery placement that had led the healthcare professional to believe it may have been a seizure. Patient had been placed on seizure medication and had not had any seizure activity after the first alleged one. Additional information was requested but had not been received as of the date of this report.
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, 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: 3389s-40, lot# va0jcu8, implanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979081
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dennis100
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« Reply #151 on: September 06, 2014, 02:23:38 AM »

Model Number 7428
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that a patient being treated for parkinson¿s disease went to the hospital for programming in (b)(6) 2014 and that at that time the patient¿s physician found their battery had depleted. The battery depletion was reported to have been ¿normal battery depletion. ¿ the patient was reported to have experienced right hand rigidity and trembling, difficulty walking, and pain at the implant site and to have experienced these symptoms following the replacement surgery. Additional information has been requested, but was unavailable at the time of this report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013492
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dennis100
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« Reply #152 on: September 06, 2014, 05:14:49 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0arp9, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0bbqp, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).
Event Description
It was reported that the patient¿s hands had started to clasp together during the night since (b)(6) 2013. After that, three months after implant, the patient began falling a lot. The patient fell once or twice a day and in (b)(6) 2014 he broke his leg. The patient had not fallen since that time. The patient had lost a lot of coordination and stumbled when he walked. The patient would hold on to something when he walked to keep himself more stable. This issue had been happening for ¿a while,¿ but the patient could not provide an exact date, and he thought his coordination could be getting worse. The healthcare provider (hcp) thought the cause of the event was gait ataxia or possible orthostatic hypotension with polyneuropathy. The therapy was still working for the patient¿s tremors. The patient had an appointment scheduled with his implant surgeon for (b)(6) 2014. Medical intervention and the patient outcome were not reported, so additional information was requested. If additional information is received, a supplemental report will be sent. Refer to manufacturing report #3004209178-2014-15622 as the patient had two ins¿s and it was not specified which was the issue.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4024800
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dennis100
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« Reply #153 on: October 12, 2014, 02:45:58 AM »

Model Number 37601
Event Date 08/06/2014
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient had ¿not been able to have effective stimulation since the implant¿ and that ¿she was worse off with her symptoms¿ following the replacement of her previously depleted implantable neurostimulator (ins). The patient had met with her physician and was told ¿it was the implanted battery that was not working¿ and that ¿they were not able to adjust stimulation. ¿ despite this, it was noted the physician had ¿cranked the stimulation up from 3. 9 to 4. 8 (volts)¿ with ¿no change¿ in the patient¿s symptoms. The patient was ¿unable to get up on her own, she was constantly freezing due to the condition, her head was falling to the side and freezes until she is assisted¿ and she had ¿lost weight¿ and had ¿no appetite¿ at the time of report. The patient ¿could not walk by herself¿ either at that time. It was reported the patient experienced ¿lethargy, loss of reflexes, paralysis, and less than 50% therapy relief¿ that was associated with the event. Information regarding interventions and the patient¿s outcome was not available. Additional information has been requested. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4118705
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dennis100
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« Reply #154 on: October 13, 2014, 12:49:16 AM »

Model Number 37603
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387s-40, lot# va01d5k, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708640, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va01ngu, implanted: (b)(6) 2012, product type lead; product id 37085-40, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

Event Description
It was reported the patient had fallen and broke their shoulder on (b)(6) 2014 and had surgery the following day. They had therapy for about 3 weeks and things were progressing. They thought their symptoms after surgery were worse than before but the last 2 or 3 days prior to report their symptoms had gotten much worse. They had worked with a physical therapist at home on the day of report and could barely walk across the room. They had more shaking getting started from a dead stop. There was a patient injury and a loss of therapeutic effect. It was noted the patient programmer batteries were dead and they had never used the programmer in two years. The patient changed the batteries and performed a check on the right side first. They saw a doctor and phone screen. After, they performed a check on the left side and they saw ¿on and ok¿ for the left side. The patient outcome was not provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4080014
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dennis100
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« Reply #155 on: October 13, 2014, 01:55:35 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# j0120726v, implanted: (b)(6) 2001, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0333858v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported the patient had a loss of therapeutic effect. The patient did have benefit from the deep brain stimulator (dbs) after implant. They had an issue with their patient programmer back in (b)(6). The patient had been ¿inpatient¿ since the beginning of (b)(6). Prior to that, the patient was an inpatient at another hospital since early (b)(6). They wanted the dbs systems checked as the patient didn¿t seem to get any benefit from the systems at the time of report. Over the past 2-3 months, the patient had stopped ambulating and had a slow decline. They did not have any big falls and they were not aware of any falls. The patient had gotten really sick and had a urinary tract infection that started a couple of weeks prior to report. While they had been an inpatient at the current hospital, they had a dramatic decline with breathing and swallowing difficulties so that they had a percutaneous endoscopic gastrostomy (peg) tube and tracheostomy. Additional information received reported it was unknown if the patient had a 50% or greater symptom reduction. The cause of the event was not determined, it was not device related and no reprogramming was needed. An mri was performed. The patient had not recovered and their symptoms were still ongoing. 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=4078072
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dennis100
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« Reply #156 on: October 13, 2014, 03:47:20 AM »

Model Number 37602
Event Date 08/06/2014
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient¿s implantable neurostimulator (ins) was changed the day prior to report and ¿the nurse who was doing the settings put the patient¿s settings too low. ¿ the patient was ¿complaining of having breathing difficulties, freezing, head fallen sideways, trouble walking,¿ and stiffness of her neck at the time of report. The patient had also reportedly ¿fallen from bed because of the freezing in her body. ¿ the patient was instructed to go to the emergency room at the time of report due to her ¿loss of therapeutic effect¿ following the ins replacement. Upon replacing the patient¿s devices, the patient had reported ¿feeling a little bit of tingling in her finger at a higher setting¿ so the nurse had lowered the patient¿s settings. Later however, when the patient recovered from anesthesia, ¿all of the parkinson¿s symptoms returned with a vengeance¿ on the morning of the report. Additional information has been requested. A supplemental report will be filed if additional information is received. Please see manufacturer report #3004209178-2014-16425 for information regarding the patient¿s other ins.

Manufacturer Narrative
Concomitant products: product id 37602, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4062858
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dennis100
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« Reply #157 on: November 07, 2014, 10:59:42 PM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient was seen last in (b)(6) 2013 and they would be seen by their clinician 2 days following report. The electrode impedances were measured and they were all fine and normal. The ins that was implanted on their right chest had a slight tingling sensation to their arm. Additional information received reported the patient still had concerns with their device or therapy, but they were working with their manufacturer representative or doctor. It was stated they had an appointment scheduled for (b)(6) 2014. Additional information received reported there was a 50% or greater symptom reduction. It was later reported that the patient was scheduled to have both of the implantable neurostimulators (inss) replaced on (b)(6) 2014. The patient was seen on (b)(6) 2014 for adjustment and reprogramming. The right stimulator was interrogated and the patient had mild paresthesia in the left arm. Right side settings were at 4. 1v, 90usec, 185hz, and 3+2- with minimal tremor in the left arm. The patient was seen on (b)(6) 2014 and there was no evidence of discontinuity of the leads of extensions. The patient¿s was also seen on (b)(6) 2014 for a device adjustment, weakness and gait difficulty. The weakness onset had been gradual and occurring in a persistent pattern for 4 months prior to the appointment, but had first occurred more than 40 years of age. Weakness had been characterized as difficulty arising from a chair, climbing stairs, walking, and increased weakness following exertion and at the end of the day. Weakness was located in the legs and on the right side only. It was associated with numbness. Patient had falls, difficulty ambulating and a gait disturbance. Onset for gait issues had been gradual starting about 8 months prior to the appointment, but was worsening. The patient had slow speech, romberg sign positive, impaired toes, and was tandem walking impaired which were noted during a physical exam. The patient was still experiencing frequent shocks with the battery with fluctuating responses of the battery. The patient was going to be scheduled for a neurosurgery appointment for a battery change. For numbness and tingling, low back pain and right leg weakness an electromyography (emg) and computerized tomography (ct) were going to be performed. Reference manufacturer¿s report number: 3004209178-2014-12463 for the patient¿s other implanted system and the shocking issues that were isolated to that system.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v368056, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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dennis100
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« Reply #158 on: November 08, 2014, 03:42:46 AM »

Model Number 37751
Event Date 09/22/2014
Event Type Other
Event Description
I had a metronic neurostimulator implanted in (b)(6) 2014 then my legs became weak, joints feel like i have arthritis, had chronic low grade temp, burning at battery and pain every where leads, battery and paddle implanted, had so much weakness in my legs that i was having trouble walking and had to have it removed at another facility in (b)(6) 2014 and still having arthritic symptoms and back pain.

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dennis100
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« Reply #159 on: November 08, 2014, 04:30:15 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389-40, lot# j0357358v, implanted: (b)(6) 2004, product type: lead. Product id: 3389-40, lot# j0340483v, implanted: (b)(6) 2004, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. (b)(4).

Event Description
It was reported that one time the device turned off within the last 2 years prior to the date of this report and the patient was sent to the hospital due to the fact the he got to the point where he could not move, walk or talk, was diaphoretic and his blood pressure went up. This had not been within the last year prior to the date of this report, so it had happened prior to the last year. No interventions or outcome were reported. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4156403
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« Reply #160 on: December 06, 2014, 12:26:14 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # va0a55s, implanted: (b)(6) 2013, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension. (b)(4).

Event Description
It was reported that after implant of the implantable neurostimulator (ins) the patient had ambulation problems. The patient thought it was a normal progression and not caused by the surgery. The patient had the implant surgeries done very close together. For the surgery, the patient was put to sleep and when they woke up they could not walk. Prior to implant the patient was able to walk. The patient was walking on their toes, freezing, and they were living in assisted living to see if their balance would come back. The patient had been feeling better than they had for years. Since implant the patient had been doing great with hardly any tremor and they had been able to reduce some of their medications. The patient had been doing physical therapy and their healthcare professional stated they could not go home because of their balance and the risk of falling down. 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=4242507
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« Reply #161 on: January 10, 2015, 02:48:08 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7436, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v281324, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. 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: 7436, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient¿s therapy wasn¿t as good as it used to be. The patient noticed this change a couple of years ago. The patient had a hard time walking and his hands shake more. His head was shaking but not as bad as it was prior to implant. The patient had set up appointments in the past, but never went to them. The patient had a follow up appointment on (b)(6) 2013. There was also a problem with the patient programmer. It had last worked a week prior. It was later reported when the patient had first had the device put in they had had a problem with the top of their head. The patient could feel electricity when they put it on but that had gone away. The patient had tremor. The patient had felt great after the first operation but now had not, the patient still could not write and had been shaking ever since she was young. It was unknown when the implantable neurostimulator (ins) had become less effective. It was noted that when the patient was in the army it was not bad and the patient sort of hid the shaking. The patient was a wreck. The patient had not felt quite as great as he should for quite a while. The patient¿s device was replaced on the day prior to the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340112
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« Reply #162 on: January 10, 2015, 04:29:07 AM »

Model Number 7428
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported the patient was hospitalized on (b)(6) 2014 for walking difficulty. By (b)(6) 2014, the patient¿s symptoms of walking difficulty and leg weakness had not improved after taking medicine every day. The patient suspected the implantable neurostimulator (ins) was turned off accidently before they took their medicine. On (b)(6) 2014, the patient was reprogrammed and the ins was not turned off. The patient¿s healthcare professional did increase the voltage by 0. 1v and their symptoms got much better. The cause of event was not determined and the patient was doing well at the time of this report.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4331580
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« Reply #163 on: January 10, 2015, 04:29:50 AM »

Model Number 37612
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported the patient was experiencing sudden symptoms of feeling terrible, swaying, being off and losing balance, staggering, and not being able to walk. The patient was not feeling well and they were experiencing balance problems around 2014-(b)(6). The patient had gone to the hospital and they were feeling much better on thursday of last week after they were sent a replacement antenna. On the day of this report the patient¿s symptoms returned and they were re-admitted to the hospital. The healthcare professional (hcp) wanted to know if there was another problem with the antenna. The hcp believed that both implantable neurostimulators (ins) were on, but one was losing charge fast and the other was also losing charge. 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. Refer to manufacturer report #3004209178-2014-23956.

Manufacturer Narrative
Concomitant: product id 37612, serial# (b)(4), implanted: 2012-(b)(6), product type implantable neurostimulator. Product id 7482a51, serial# (b)(4), implanted: 2011-(b)(6), product type extension. Product id 3387s-40, lot# v194784, implanted: 2011-(b)(6), product type lead. Product id 37651, serial# (b)(4), product type recharger. Product id 37642, serial# (b)(4), product type programmer, patient. Product id 3387s-40, lot# v154598, implanted: 2009-(b)(6), product type lead, product id 7482a51, serial# (b)(4), implanted: 2009-(b)(6), product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330538
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« Reply #164 on: January 10, 2015, 11:50:38 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that two days prior to the date of this report the patient had been defibrillated and since then the patient¿s parkinson¿s disease had been declining. Following the defibrillation when the patient had returned to the nursing unit the patient¿s conversation had not made sense and he was disoriented to place and time. The patient¿s muscle tone was there but when he had stood up it required two people to help him walk and his gait was shuffling. The patient tried to drink with his finger and had hallucination. The patient was getting worse on the date of this report. It was noted that the patient¿s wife knew how to operate the patient programmer but the programmer was not with them at the time of this report. The healthcare professional thought the stimulation was on because you could see the artifact on the electrocardiogram (ekg). They were afraid to use the patient programmer to read the device status after the defibrillation. The patient¿s wife was instructed on using the programmer to the check the device status and it read on and ok so there was nothing wrong with the deep brain stimulator device. The patient¿s medical issues were not related to the deep brain stimulator.

Manufacturer Narrative
Product id 3389s-40, lot# v902684, implanted: 2012 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4293886
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« Reply #165 on: February 07, 2015, 07:28:52 AM »

Model Number 37602
Event Date 12/08/2014
Event Type Injury
Event Description
It was reported that the gait was worse secondary to left implantable neurostimulator (ins) deep brain stimulator (dbs). The patient had right sided paresthesia secondary to left ins dbs. The patient reported that when the left ins was on side effects of right sided paresthesia described as surging/tingling present. The patient reported that the left dbs settings made the gait worse. The patient reported that he walked best when the left dbs was off and the right dbs was on. Actions taken due to the event included reprogramming. The patient reported the display showing ¿call your doctor¿ icon. The elective replacement indicator (eri) indicator was showing up on the left ins despite the battery potential being at 2. 73 on (b)(6) 2014 and 2. 77 on (b)(6) 2015. The patient reported on (b)(6) 2014 that he was checking the left dbs battery with his patient controller and it read ¿eri. ¿ the patient last had his battery changed on (b)(6) 2013. The patient continued to turn dbs off at night and use it primarily while eating and when needing to use his right hand. The patient was not able to adjust stimulation. At one point the patient¿s amplitude was decreased to 0. 6 volts. Impedances were within normal limits. The patient believed that the battery should have lasted longer. Longevity calculations were performed and it appeared to be normal eri. The current battery level was 2. 7 although the trip point for eri is 2. 6 volts. It appeared to be premature eri message. The patient had an unscheduled clinic or office visit. The event was reported as ongoing. The patient was not tolerating the dbs therapy, however they were currently attempting to rule out dbs therapy and it may not be related. The patient reported these symptoms previously. The patient¿s settings were decreased due to the patient¿s walking being affected while the stimulator was on. The patient was not able to keep the left ins on most of the time due to side effects of paraplegia and gait problems. The patient¿s setting were decreased 1 volt but when the stimulation was turned on the patient was having mild paraplegia, voice change, but the tremor was better than before the ins was lowered.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v006354, implanted: (b)(6) 2006, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 748240, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3387s-40, lot # v006354, implanted: (b)(6) 2006, product type lead; product id 748240, serial # (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4470622
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« Reply #166 on: February 07, 2015, 07:29:58 AM »

Model Number 37601
Event Date 01/05/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id; 64002, lot# n324251, implanted: (b)(6) 2012, product type: adapter. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# j0537471v, implanted: (b)(6) 2005, product type: lead. Product id: 3387-40, lot# j0542964v, implanted: (b)(6) 2005, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension. (b)(4).

Event Description
It was the patient had trouble waking and was admitted to the hospital on (b)(6) 2015. The patient was not able to walk or get up and their parkinson¿s symptoms were getting worse. The manufacturing representative met with the patient the day prior to this report and found the implantable neurostimulator (ins) was at end of service (eos). The ins battery depletion was normal. The ins was replaced the same day. The patient was frail and the ins looked like it was going to come out of their chest. The healthcare professional (hcp) was concerned another ins would erode through the skin. The hcp decided to remove the ins and pocket adaptors and implant two inss. One of the new ins's was implanted on the patient other side. Before the two new ins's were implanted the hcp noticed the old ins had caused erosion in the skin and there was a hole where the edge of the ins had been sitting. The hcp had to cut some of the skin and sew it back up. The hcp felt the ins was too large and the edges were too sharp. The patient was started on intravenous antibiotics and the patient stayed the night in the hospital. The cause of the erosion was not determined. The inss were turned on after implant and the patient had been receiving effective therapy in the recovery room. All impedances were measured to be normal.

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« Reply #167 on: February 07, 2015, 07:31:24 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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« Reply #168 on: February 07, 2015, 12:10:49 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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« Reply #169 on: February 07, 2015, 12:11:37 PM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient was experiencing paresthesia and difficulty walking. The symptoms had occurred following implant. The patient had had problems with her arms since the device was implanted in (b)(6) 2012. Both arms had problems, arms were swollen at night time and some nights it was more than others. The patient kept twisting and turning at night because of her arms. After discussing with her healthcare professional the patient was told she was fine. The healthcare professional was seen a long time ago and had not been seen since. The patient had had a problem with their device since surgery and had gone through a 2nd surgery on one side, they had to open up the patient¿s head and do a wiring thing. The patient¿s wires were crooked and the patient had had surgery but they were still the same, the patient had not seen any change. The patient was unsure what was wrong with it because, they were having problems with their head but now was having trouble with their neck. Every time the patient saw their healthcare professional they got numb on one side which had never happened before, they had had it before but it had gone away. The patient had had it in both legs prior to surgery. After her legs were fine and her arms, but she could not sleep at night. The patient had a funny feeling in her arms. The healthcare professional told the patient that it had nothing to do with surgery. It was noted that it might be an iron deficiency, but the patient wondered why their legs were not affected since they believed an iron deficiency would not impact just their arms. The patient¿s walking was very bad, she fell on her face when she walked and one time she fell and broke her hand but was told by her healthcare professional that this was not from parkinson¿s. The patient had an appointment scheduled for (b)(6) 2014. The patient had had a computerized tomography (ct) scan and found out there was a problem with the wiring in the brain that they had never told her about. The ct had been taken at the second surgery in (b)(6) 2012. The patient also had an appointment scheduled for (b)(6). 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
Product id 37603, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3387-40, lot# va00fze, implanted: 2012 (b)(6); product type lead product id 3387s-40, lot# va005vq, implanted: 2012 (b)(6); product type lead product id 3387-40, lot# va00fze, implanted: 2012 (b)(6); product type lead product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37603, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# va005vq, implanted: 2012 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4384352
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« Reply #170 on: February 07, 2015, 12:12:12 PM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

Event Description
It was reported the patient was having a lead revision next year due to gait freezing. The patient had a lead in the subthalamic nucleus for parkinson¿s disease and the revision is for a lead to be placed in the ¿stn and snr. ¿ the patient¿s healthcare professional (hcp) did not want to remove the entire system for an mri so the hcp was going to plan the revision from the patient¿s old mri and just replace the lead. The manufacturing representative was not aware of anything wrong with the lead. No outcome was 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=4380328
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« Reply #171 on: March 07, 2015, 05:01:59 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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« Reply #172 on: March 07, 2015, 05:02:33 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had waist/hip pain in (b)(6) 2015. The patient went to the hospital for treatment, but the reason for the pain was unknown. The patient¿s family suspected the implantable neurostimulator (ins) was depleted and that caused the patient to not be able to stand and walk. The patient was hospitalized at the time of this report. The reporter wanted the patient¿s ins to be checked by a manufacturing representative. Follow up indicated that it was unknown if the ins had depleted and the patient still had waist/hip pain and they could not stand or walk. No interventions or outcome were reported regarding this event. Additional information could not be obtained. Should additional information be received the event will be updated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4520956
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« Reply #173 on: March 07, 2015, 05:03:15 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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« Reply #174 on: April 19, 2015, 09:35:31 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
Finet, p. , delavallee, m. , raftopoulos, c. Idiopathic intracranial hypertension following deep brain stimulation for parkinson's disease. Acta neurochirurgica. 2015. Doi: 10. 1007/s00701-015-2354-3. Summary: idiopathic intracranial hypertension (iih) is a syndrome characterized by an increased intracranial pressure of unknown origin arising mainly in overweight females. The typical symptoms of iih are headaches and papilledema associated with visual disorders, which can often evolve to blindness. We describe the first patient who developed a clinical syndrome related to an iih following a bilateral subthalamic deep brain stimulation (dbs) procedure for parkinson¿s disease with the particularity that the clinical expression of the iih syndrome was atypical because of the presence of intracerebral electrodes. Reported event: one (b)(6) female patient was treated with bilateral deep brain stimulation (dbs) implantation of the subthalamic nucleus (stn) for advanced parkinson¿s disease. It was noted that the patient was overweight with a body mass index (bmi) of 46 kg/m^2. The initial postoperative course was marked by a remarkable improvement of the motor symptoms leading to withdrawal of levodopa. However, the patient progressively developed personality changes with apathy and bulimia accompanied by an important weight gain of 15kg in 2 months (bmi: 52 kg/m^2). Three months after surgery, the patient gradually developed a discreet left hemiparesis, a left hemihypoesthesia, dysarthria, and gait disorder linked to her hemiparesis. She also complained of blurred vision and pulsatile holocranial headache. Neurological examination revealed a pseudomeningocele at the level of the entry point of each dbs electrode. A brain ct scan performed 86 days after implant surgery demonstrated a hypodensity surrounding both intraparenchymal electrodes; there was reportedly hypodensity surrounding the right electrode at the level of the basal ganglia and internal capsule. It was noted that there was a suspected hardware infection. However, the white blood cell count, c-reactive protein level, and the wound examination were normal. In the absence of other infection signs, an mri was performed 87 days after implant surgery, which revealed edema surrounding the intracranial electrodes predominantly around the right electrode without any signs of infection on the diffusion-weighted imaging and t1 with gadolinium sequences. Furthermore, the mri revealed a dilation of the optic nerve sheets and an intrasellar meningocele compatible with an idiopathic intracranial hypertension (iih). The mri showed distension of the optic nerve sheaths, a flattened posterior optic glob, slight protrusion of the optic head, an empty sella turcica and an upward tortuosity of the optic nerve. No sinus thrombosis was observed. A fundoscopy showed a papilledema, and a lumbar puncture (lp) confirmed the presence of a high opening pressure (36 cmh2o). The reporter stated that the patient¿s atypical symptomatology was related to the csf infiltration along the intraparenchymal electrodes and then in the extracellular space in the context of intracranial hypertension. The right electrode trajectory was infiltrated along the entire electrode, whereas the left electrode only had a subcortical edema, with the hyper-t2 signal extended in the right posterior arm of the internal capsule, right cerebral peduncle and right thalamus. These radiological findings explained the patient¿s left hemiparesis, left hemihypoesthesia and dysarthria, which were related to swelling of their neuroanatomical substrates. Two cerebrospinal fluid (csf) taps were performed (csf withdrawal of 28 and 40 cc) with a significant transient amelioration of her symptoms. A diet with a loss of weight (bmi: (b)(6)) resulted in complete regression of the symptoms four months after treatment initiation. The reporter stated that the weight gain provoked by the bilateral stn-dbs appeared to be responsible for the ihh development or perhaps for the worsening of a preexisting paucisymptomatic ihh. A brain ct scan performed 2 months after symptom regression (8 months after dbs implant) showed a complete disappearance of the hypodensities surrounding the electrodes. The source literature did not include any specific device information. Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about patient information and additional information regarding the reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4). (b)(4) intracranial hypertension.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620602
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« Reply #175 on: May 09, 2015, 03:05:42 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0ccdl, implanted: 2013-(b)(6), product type: lead. Product id: 3708660, serial# (b)(4), implanted: 2013-(b)(6), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported the patient was having an mri for numbness in their extremities, gait imbalance, and to assess for mini stroke. 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=4690231
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« Reply #176 on: May 09, 2015, 03:06:26 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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« Reply #177 on: May 09, 2015, 03:07:07 AM »

Model Number 37602
Event Date 03/17/2015
Event Type Injury
Event Description
It was reported that the patient was scheduled to have an implantable neurostimulator (ins) replacement on (b)(6) 2015, but then fell on (b)(6) 2015 and the reporter believed ¿it had done something to the wire and it was not working now. ¿ the patient could not walk, do anything, or barely maneuver since the fall. The reporter took the patient to the emergency room (er) because she thought the battery ¿had given out, which it had however she was told that it was not dead, it was still working somewhat, had a little juice left but they ended up replacing it. ¿ the reporter stated that the patient ended up having the battery replaced on (b)(6) a week prior to the report. It was unclear if there was a wire issue or what the patient outcome was, so additional information was requested. If additional information is received, a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389-40, lot# j0555401v, implanted: 2005, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4699304
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« Reply #178 on: May 09, 2015, 03:08:05 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v353787, implanted: (b)(6) 2009, product type: lead; product id 7482a51, 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 that when the patient¿s settings were high, their side effects and walking seemed to get worse. The patient had a very severe head, vocal, and hand tremor. The patient had always had this issue. The first implant helped with the patient hand, but could not control the head so they were unable to eat or drink. A revision was done to ¿a research area called sta. ¿ that was ineffective so the patient was being referred to the university of florida for another research area and dual lead. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4707739
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« Reply #179 on: June 08, 2015, 06:57:31 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had surgery last (b)(6) and ¿it had not worked since the implant. ¿ it was noted the patient would ¿pick up speed when they would talk. ¿ it was stated since the surgery the patient had fallen down 6-7 times. It was noted the patient had speech impairment and it was hard to understand them. It was later reported that there was a poor communication screen but they were eventually able to conform with both the left and right sides on and ok. Stimulation was turned off and back on. Since implant the patient had been falling down and losing her balance much more than before the implant. The patient¿s balance and falls had gotten worse after implant and the patient was unsure if it was safe to walk and she used a walker. The patient had had a major fall about 2 months after implant,(b)(6) or (b)(6), she had fallen on the carpet while she was hanging clothes. It was noted that the patient went to rehab after the fall. Patient wanted to discuss turning therapy off to see if it would improve her falls/balance. Patient inquired about lead placement and how it effects stimulation. The patient was not sure if the deep brain stimulator was causing her falls but felt that it was either the deep brain stimulator or disease progression. It was later reported that since implant the patient had balance issues. The patient had never had this before implant and had fallen multiple times. The patient was told that it was due to her recent surgery. The patient was still falling and had broken her hand from a fall. Reference manufacturer¿s report number: 3004209178-2015-08800.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3387s-40, lot# va01zjk, 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, product type: extension. Product id: 3387s-40, lot# va01zjk, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id 37603 lot# serial#(b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4761849
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