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Author Topic: Deep brain stimulator - Walking/Gait  (Read 77130 times)
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dennis100
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« Reply #180 on: June 08, 2015, 06:58:24 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient was left in a nursing home, worse off. Prior to the patient getting the deep brain stimulator he could walk and talk but now he was confined to a hospital bed in a nursing home. The patient could barely feed himself. The patient had gone through the surgery wide awake ¿like a trooper. ¿ it had all gone downhill about 2 months after the deep brain stimulator surgery. The patient had good progress after the surgery for a week to a week and a half or two weeks. The patient was walking, talking, and doing exercises but after that the patient had become wheelchair bound and in a nursing home. The patient could not talk , walk or feed himself. The patient¿s system was checked two years prior to the date of this report. Patient¿s status was unknown. Reprogramming had been tried. The patient had been his healthcare professional¿s and still could not walk or talk.

Manufacturer Narrative

Event Description
It was later reported the patient had deep brain stimulator surgery 4 years prior to the date of this report and it had worked great for almost 2 years but then things had gone downhill fast. The patient could not text.

Manufacturer Narrative
Concomitant products: product id: neu_unknown_lead, serial# (b)(4), product type: lead. Product id: 3387s-40, lot# v626366, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762647
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dennis100
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« Reply #181 on: June 08, 2015, 06:59:01 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v187428, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead. (b)(4).

Event Description
It was reported that the device was implanted on (b)(6) 2013 and right after implant the patient lost functionality. The patient was able to walk with help but was not able to use his hands to eat, could not turn over in bed and could not move himself. The patient had physical and occupational therapy and had regained 30-40% of his functionality. The patient took a lot more sinemet orally. The issues had continued until the patient had a revision. Reference manufacturer¿s report number: 3004209178-2015-09174.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4774612
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dennis100
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« Reply #182 on: July 16, 2015, 12:14:36 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient experienced ¿stimulation in the wrong location¿ and a ¿change in gait¿ involving their ¿left side implant. ¿ it was further reported the patient ¿had new-onset gait freezing with stimulation. ¿ a post-operative ct scan was performed and found the patient¿s ¿lead had deviated when it left the insertion cannula (20mm above the target)¿ and that ¿this resulted in the electrodes being positioned in the wrong brain structure (the posterior subthalamic area (psa), not the subthalamic nucleus (stn) as planned). ¿ it was noted the ¿left lead deviated¿ and that ¿both leads were revised as both ended up medial to the initial plan. ¿ it was additionally noted there was a ¿bent lead. ¿ the patient¿s leads were explanted and replaced as a result of the event. The patient was ¿receiving effective therapy with no gait freezing¿ following their bilateral lead revision. Additional information was 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=4850234
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dennis100
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« Reply #183 on: July 16, 2015, 12:15:18 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389s, product type: lead. Product id: 37085, product type: extension. Product id: 37651, product type: recharger. Product id: 37642, product type: programmer, patient. (b)(4).

Event Description
The patient was implanted on (b)(6) 2013 due to parkinson. After implantation, the patient felt the effect was not good. The physician reprogrammed the device many times, but the patient was still not satisfied with the effect. It was unknown if there was a 50% or greater symptom reduction. The patient was epileptic two times in the week after the surgery. The urine tube and gastric tube was not pulled out after the surgery. After surgery it was difficult for the patient to walk. Reprogramming results showed the device was normal. The patient was disequilibrium and dysphasia. No troubleshooting has been done and the event cause was not determined. 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=4824533
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dennis100
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« Reply #184 on: July 16, 2015, 12:16:18 AM »

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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dennis100
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« Reply #185 on: July 16, 2015, 12:17:11 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387-40, lot# 0209047236, implanted: 2015-(b)(6), product type: lead. Product id: 3387-40, lot# 0209313922, implanted: 2015-(b)(6), product type: lead. (b)(4).

Event Description
During stage two, impedance testing was performed once the system was fully connected. Electrode 8 was out of range, high impedances of >40 ,000. The surgeon disconnected the lead/extension and extension/implantable neurostimulator (ins) on the right side, cleaned and dried leads, then reconnected the system. Impedances were re-tested and 8 was still out of range. The surgeon decided not to continue troubleshooting and closed up. It was noted that it was unknown which lead was the right lead, but the issue was only with the right lead. The company representative confirmed that there was no effect on the patient immediately post-op as the system was yet to be programmed. The neurologist was informed and programmed the patient accordingly. The patient was receiving effective therapy the week following implant. It was later reported that the post-op ct showed the leads were implanted on the medial side of the original plan. The patient experienced a new onset of gait freezing with stimulation. The change in gait occurred at the left and right side of implant. The physicians have turned off the stimulation and will revise (leads will be replaced) in (b)(6). Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of 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=4828199
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dennis100
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« Reply #186 on: August 08, 2015, 10:12:29 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported ¿it did not always improve the quality of life. ¿ the patient no longer walked since having one installed and now had tremors that he never had before.

Manufacturer Narrative
Concomitant: product id neu_unknown_lead, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4913392
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dennis100
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« Reply #187 on: August 08, 2015, 10:13:07 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead. Product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was originally reported on (b)(6) 2013 the patient was having program issues with their gait and ability to start walking. The reporter stated they wanted to know if there was a deep brain stimulation data base to find possible solutions for their particular issues. Additional information received reported that the implantable neurostimulator (ins) and extensions were explanted due to generator erosion. The patient recovered without sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953266
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dennis100
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« Reply #188 on: September 19, 2015, 03:17:31 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 #189 on: September 19, 2015, 03:18:14 AM »

Model Number 37612
Event Date 07/27/2015
Event Type Malfunction
Event Description
A consumer reported they had a problem where they were not aware their stimulation was off. For four days the patient was trying to walk and they could not. The patient contacted a health care provider (hcp) and they walked the patient through checking the implantable neurostimulator (ins) and they found the ins had been off for four days. The patient's indication for use is parkinson's dual. 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# v530117, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v530117, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024964
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dennis100
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« Reply #190 on: September 19, 2015, 03:19:00 AM »

Model Number 37601
Event Date 08/02/2015
Event Type Malfunction
Event Description
The consumer via a manufacturer representative reported that an implantable neurostimulator (ins) was implanted in the patient on (b)(6) 2014 due to parkinson¿s disease. On (b)(6) 2015, the patient had difficulty walking and adjusted the parameters with the patient programmer, but had no improvement. The patient¿s family requested a solution for the symptom. No troubleshooting was done to provide insight to the issue and the cause of the event was not determined.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5035261
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