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Author Topic: Deep brain stimulator - Dyskinesia  (Read 18703 times)
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dennis100
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« Reply #30 on: July 04, 2014, 09:09:55 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the patient¿s therapy was great initially and had been partially effective for a few years. It was noted that as the patient¿s disease had progressed the patient would have dyskinesia in her leg and tremor in her hand on the same side at the same time. It was noted that it was frustrating turning it up would make one thing better and the other worse. It was further noted that about 4 years prior to the date of this report, they had redone the lead on one side and it was still not perfect but the patient was living with it. The patient stated ¿happened a few times where an error was made in programming and she had to come back the next day to have it redone. ¿ the patient was switched from monopolar to bipolar. Patient¿s frequency was increased due to tremor being worse so it was switched from 135 to 175 which was done a week prior to the date of this report and the whole weekend the patient was miserable saying she felt wound up. The patient had gone back on monday following the weekend and was switched to a lower frequency and on that same day after going home, the patient had noted that the frequency range was screwed up. It was noted that a different time it was tried to be modified so the patient could change the amplitude and frequency and the frequency was changed up but the patient was unable to turn up the voltage and had to go back in 2 days later. Patient was put back to where it was and patient went back again for another try at increasing the frequency but that had not worked so the patient had gone in the day prior to the date of this report to turn the frequency back down to where it was before and something was screwed up because, she was unable to turn up the voltage beyond 2 volts so they had to go back to the previous range which was 1. 5 volts to 3 volts. The patient had been in 3 different times in the week prior to the date of this report to make changes. Patient would be miserable for a few days and then the healthcare professional would change it. The patient¿s lead position was not optimal. Additional information received reported the cause of the event was improper lead placement. The event was attributed to the lead. A surgical revision of the lead was done in 2010. The patient had not required hospitalization and the patient outcome was non-serious illness/injury. It was noted that the patient had not been seen in the office since 2012.

Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# v357495, implanted: 2010 (b)(6); product type lead product id 3389s-40, lot# v355055, implanted: 2010 (b)(6); product type lead product id 3389s-40, lot# v285199, implanted: 2010 (b)(6); product type lead product id 37085-60, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2010 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3856506
« Last Edit: September 19, 2015, 02:51:16 AM by dennis100 » Logged
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« Reply #31 on: July 04, 2014, 10:43:45 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported the patient had ¿experienced dyskinesias¿ the week prior to report. It was stated the patient¿s physician ¿suspected overstimulation and so changed the parameters¿ from 3 volts at 180 hz and 210 microsec to 2 volts at 130 hz and 60 microsec. It was further stated the patient¿s ¿symptoms improved after reprogramming. ¿ it was noted that a x-ray test of the system and impedance testing ¿showed no issues. ¿ it was then reported the patient came back to their physician during the week of report because an elective replacement indicator (eri) message had shown up on their patient programmer with the implantable neurostimulator (ins) at 2. 8 volts. It was noted the physician programmer was reported to have showed an out of range (oor) message at that time. It was reported the patient was ¿unable to adjust stimulation¿ at the time of report. It was stated that it had been planned but not yet undertaken to replace the patient¿s ins as a result of the event. It was noted the patient was alive with no injury at the time of report. Additional information has been requested; a supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3897093
« Last Edit: September 19, 2015, 02:51:45 AM by dennis100 » Logged
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« Reply #32 on: August 11, 2014, 01:30:24 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient suffered an electric shock of 220 volts while using an autogenous welder. The patient experienced worsening stiffness, ¿a predominance of right side¿, with increased linguial dyskinesias and residual tremor. The patient¿s symptoms had increased in the three days prior to the patient¿s visit with the physician. While the hcp was attempting to adjust the implantable neurostimulator (ins), the device suddenly turned off, with parameters set to 0 volts, 0 microseconds, and 0 hertz. The device had to be restarted. Prior to the patient being shocked, the device parameters and impedances were as follows: left ins: c+, 0-, 1-, 2. 8 v, 90 micros, 130 hz right ins: c+, 10-, 3. 0 v, 90micros, 130 hz impedances in ohms, measured at 0. 7 v: c/3 3183, c/3 4165, 1/3 4107, 2/3 4586, c/8 2128, c/9 4805, c/11 2406, 8/9 5794, 8/11 4201, 9/10 4886, 9/11 6729 after experiencing the shock, the device parameters were as follows: left ins: c+, 1-, 2-, 3. 5 v, 90 miros, 130 hz right ins: c+, 9-, 10-, 3. 5 v, 90 micros, 130 hz impedances were out of range on electrode pairs c/2 and c/3.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3946919
« Last Edit: September 19, 2015, 02:52:01 AM by dennis100 » Logged
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« Reply #33 on: September 06, 2014, 12:45:15 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Patient Outcome Required Intervention
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 individual patient information and additional information regarding the reported events. Concomitant medical products: product id: 3387, lot# unknown, product type: lead. (b)(4).

Event Description
Sriram, a. , foote, k. D. , oyama, g. , kwak, j. , zeilman, p. R. , okun, m. S. Brittle dyskinesia following stn but not gpi deep brain stimulation. Tremor and other hyperkinetic movements (new york, n. Y. ). 2014;4:242. Doi: 10. 7916/d8ks6ppr summary: the aim was to describe the prevalence and characteristics of difficult to manage dyskinesia associated with subthalamic nucleus (stn) deep brain stimulation (dbs). A small subset of stn dbs patients experience troublesome dyskinesia despite optimal programming and medication adjustments. This group of patients has been referred to by some practitioners as brittle stn dbs-induced dyskinesia, drawing on comparisons with brittle diabetics experiencing severe blood sugar regulation issues and on a single description by mclellan in 1982. We sought to describe, and also to investigate how often the ¿¿brittle¿¿ phenomenon occurs in a relatively large dbs practice. An institutional review board-approved patient database was reviewed, and all stn and globus pallidus internus (gpi) dbs patients who had surgery at the university of florida from july 2002 to july 2012 were extracted for analysis. There were 179 total stn dbs patients and, of those, four stn dbs (2. 2%) cases were identified as having dyskinesia that could not be managed without the induction of an ¿¿off state,¿¿ or by the precipitation of a severe dyskinesia despite vigorous stimulation and medication adjustments. Of 75 gpi dbs cases reviewed, none (0%) was identified as having brittle dyskinesia. One stn dbs patient was successfully rescued by bilateral gpi dbs. Understanding the potential risk factors for postoperative troublesome and brittle dyskinesia may have an impact on the initial surgical target selection (stn vs. Gpi) in dbs therapy. Rescue gpi dbs therapy may be a viable treatment option, though more cases will be required to verify this observation. Reported event: one (b)(6) male patient experienced right upper extremity and right lower extremity dyskinesia at both the 1 and the 2 contacts on the deep brain stimulation (dbs) lead following left-sided subthalamic nucleus (stn) dbs implant. It was noted that the 1 and 2 dbs lead contacts corresponded to the best therapeutic benefit during programming sessions. The reporter stated that multiple programming strategies were employed, including attempts at slow stimulation titrations, and the use of a more dorsal dbs contact site. Reportedly, the dyskinesia only abated when the dbs was turned off. It was noted that attempts were made to commensurately decrease carbidopa/levodopa dosage in combination with stimulation changes, but this reportedly worsened the patient¿s off state, though at low medication dosages dyskinesia abated. The reporter stated that the patient experienced a similar clinical scenario when the right stn dbs was added. Reportedly, at settings that improved his freezing of gait, the patient had bothersome left lower extremity dyskinesia. It was noted that many other attempted settings failed to capture his gait freezing and the off symptoms. The reporter stated that the patient underwent rescue bilateral staged globus pallidus internus (gpi) dbs in a single operative sitting, and following programming, the dyskinesia completely abated, and the patient was able to maintain a smooth on medication state. The source literature included the following device specifics: lead model 3387 further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3976613
« Last Edit: September 19, 2015, 02:52:30 AM by dennis100 » Logged
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« Reply #34 on: September 06, 2014, 06:18:06 AM »

Model Number 37612
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37092, lot# 337540001, implanted: (b)(6) 2012, product type: accessory; product id 3 708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead; product id 37651, serial# (b)(4), product type: recharger; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported the patient recently had battery replacement surgery and the first implantable neurostimulator (ins) had lasted 23 months. The patient had been implanted now with a rechargeable ins and they experienced some problems. The new device was ¿cross-wired¿ when it was implanted but it was ¿not that big of a deal. ¿ the battery was implanted backwards. It was stated the battery was flipped and the problem was resolved with programming. The patient felt like the ins was going on and off and they felt an electrical charge down their right side fairly often and they were not talking as well or doing as well as with the previous deep brain stimulator (dbs). The patient was never able to charge up passed 75%. They suspected there was a problem with the battery. When the patient charged the day prior to report their ins battery level started at 50% and they had all 8 coupling bars. The patient tried to recharge the ins for ¿half a day¿ and they never got passed 75%. The patient did monitor while they recharged and would reposition the antenna to get 8 coupling bars. There was nothing ¿medically wrong¿ with the patient. It was further reported it ¿sounded¿ like the surgeon switched the left brain extension and the right brain extension during the battery exchange so the patient was doing poorly because the settings for the left were in their right brain and vice versa. The patient¿s doctor had switched it back during reprogramming and they felt much better. The patient was scheduled to go back to see their neurologist soon. Additional information received reported since the change out they had times when they would get an overstimulation feeling that was not associated with movement. They would also get it when they recharged, typically 20 minutes in. However, it was noted to have happened immediately on the day of report when they were in the office with the manufacturer representative and it gave them a dyskinetic feeling. They would get the same overstimulation feeling with telemetry. The impedance measurements were normal. The patient was too sore for palpation. It was further reported the patient was a high energy user. They had recharged the implant for 8 hours and could not get to 100%. It was further reported the patient tried to charge the ins the night prior to report and it overstimulated her. It was noted the ¿whole right side was jumping. ¿ they felt like the stimulation was going on and off by itself. The current would go down their right side and it was the same feeling as when their doctor would program her. They were reprogrammed the week prior to report by their doctor and it worked for a little while. It was stated the non-rechargeable device had worked good but the rechargeable one had not worked well since the implant. It was not a programming issue but the battery did not work correctly. The device would overstimulate the patient and their arm would jump. Additional information received reported the patient had dyskinesia when they would recharge. The patient was given an expanded ability to reduce their stimulation while they recharged so they could charge without major dyskinesia. This allowed the patient to finally reach 100%. There was also a complaint about the patient¿s voice but it seemed the same on and off so they guessed it might be just the progression of the disease. The patient agreed that they were doing very well with their therapy and they were charging fine at the time of report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4030799
« Last Edit: September 19, 2015, 02:52:52 AM by dennis100 » Logged
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« Reply #35 on: November 07, 2014, 11:27:10 PM »

Model Number 37601
Event Date 09/25/2014
Event Type Injury
Event Description
It was reported there was high impedances on several contacts for the right stn after implantable pulse generator (ipg) replacement surgery on (b)(6) 2014. The impedances for electrode combinations case and 10, case and 11, 8 and 10, 8 and 11, 9 and 10, 9 and 11, and 10 and 11 were all greater than 40,000 ohms. Programming to pre-operative settings was not possible, which resulted in dyskinesia on the left side of the patient's body. The cause of the dyskinesia was reported to be due to programming, and that the issue was related to device or therapy but not related to the implant procedure. The issue resulted in in-patient hospitalization. The wires were detached and reattached to the ipg, and the issue was resolved without sequelae on (b)(6) 2014.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v353789, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot # v319151, implanted: (b)(6) 2010, product type lead; 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; product id neu_unknown_prog, serial # unknown, product type programmer, physician. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4215138
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« Reply #36 on: March 07, 2015, 04:36:25 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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« Reply #37 on: April 19, 2015, 02:10:15 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was admitted to the hospital with hallucinations and increasing dyskinesia. It was noted that there was no alleged product issue and there were no device related actions required as a result of the event. It was confirmed that the event was only therapy related and not device related. The patient¿s family felt that they were taking too much of the drug prolopa. Prolopa was stopped and gradually restarted. It was specified that prolopa was gradually administered beginning in (b)(6) 2014. Therapy was suspended four months later, at which point the outcome was resolved without sequelae.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4606410
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« Reply #38 on: May 09, 2015, 01:55:12 AM »

Model Number 37602
Event Date 03/25/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, product type lead. Product id: neu_unknown_prog, product type: programmer, physician. (b)(6).

Event Description
It was reported the patient went to the hospital for unknown reasons and was experiencing parkinson¿s symptoms and dyskinesia. The manufacturing representative did not know if the patient¿s medication had been adjusted. On (b)(6) 2015, the patient went into cardiac arrest and had been resuscitated. The manufacturing representative had gone to the hospital and checked the patient¿s device. Everything was found to be in normal working order and all impedances were in normal range. At the request of the patient¿s healthcare professional (hcp), stimulation was turned down from 3. 8 to 2. 5v. The patient had been intubated, was unable to communicate, and remained in the intensive care unit. The patient had their implantable neurostimulator (ins) replaced on (b)(6) 2015. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698566
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« Reply #39 on: May 09, 2015, 01:55:52 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient experienced a shocking/jolting sensation and a burning sensation postoperatively. Dyskinesia was also reported. Impedances had been measured intraoperatively and were within normal ranges. X-rays showed no problems with the system and the leads were in the correct position. The patient had not fallen. The implantable neurostimulator (ins) was replaced.

Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4728440
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« Reply #40 on: August 08, 2015, 08:16:58 AM »

Model Number 37601
Event Date 06/09/2015
Event Type Malfunction
Event Description
It was reported the patient had dyskinesia symptoms after their implantable neurostimulator (ins) was replaced the day prior to this report. The patient¿s previous ins was replaced due to normal battery depletion. The patient had contacted their healthcare professional (hcp) about the symptoms. The ins was on and okay when the patient checked the ins with patient programmer. 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: neu_unknown_lead, product type: lead. Product id: neu_unknown_ext, product type: extension. Product id: neu_ptm_prog, product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4883712
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« Reply #41 on: August 08, 2015, 08:17:40 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 #42 on: August 08, 2015, 08:18:23 AM »

Model Number 37612
Event Date 06/25/2015
Event Type Malfunction
Event Description
It was reported the patient¿s feet had dyskinesia six days after implant. On (b)(6) 2015, the implantable neurostimulator (ins) was turned off and the symptoms had improved. On the following day, the ins was turned back on and the patient had dyskinesia again. The patient was ready to live in the hospital and have the device reprogrammed. The cause of the event was not determined and the patient¿s family wanted to know if there was a better solution for the symptoms. No interventions or outcome were reported regarding this event. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949556
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« Reply #43 on: September 19, 2015, 02:53:43 AM »

Model Number 37601
Event Date 03/31/2015
Event Type Malfunction
Event Description
A consumer reported that a few days after reprogramming, their dyskinesia came back. This had been occurring since implant of their initial device in (b)(6) 2009 and with each implantable neurostimulator (ins) since then. Since the initial implant in 2009, t he patient had been reprogrammed every 4-6 months. The current return of dyskinesia was worse than after the implant in 2009. The dyskinesias were better than they were in 2009, but this was still an intermittently reoccurring issue following reprogramming. Every since (b)(6) 2009, the patient¿s symptoms seem to get worse. The patient contacted the manufacturer to see if the labeling had anything about staying out of the sun. Since 2013, the patient has had issues with movement that are gradually getting worse to the point where they could barely move. The patient has to sit often and they cannot turn sides in their bed because their muscles are so stiff. The patient stated they were a ¿problem child¿ with medication since day one and that was why their neurologist suggested deep brain stimulation (dbs). The patient was bad with medication and they had every side effect. Every parkinson¿s disease medication and muscle relaxer was tried and the patient every side effect listed so they decided to try dbs. The patient¿s indication for use is parkinson¿s dual and movement disorders. The patient had an appointment scheduled with their health care provider (hcp) on (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.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v182607, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 3389s-40, lot # v324755, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5032859
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« Reply #44 on: September 19, 2015, 02:54:29 AM »

Model Number 37601
Event Date 07/28/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: 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: 3389s-40, lot# v867003, implanted: (b)(6) 2012, product type: lead. Product id: 3389s-40, lot# v867003, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
The patient reported that she fell on (b)(6) 2015 and hit her head and pelvis. After the fall she had trouble moving and an intermittent return of dyskinesias. This was considered a sudden issue. The implantable neurostimulator (ins) was on and ok. She had an appointment to see her healthcare provider (hcp) on (b)(6) 2015. The patient's indications for use were parkinson's dual and movement disorders. No intervention or patient outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024831
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