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Author Topic: Deep brain stimulator - Walking/Gait  (Read 88494 times)
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dennis100
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« Reply #120 on: January 26, 2014, 03:09:00 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 07/08/2010
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: gruber d, kuhn aa, shoenecker t, et al. Pallidal and thalamic deep brain stimulation in myoclonus-dystonia. Mov disord. Aug 15 2010; 25(11):1733-1743. Summary: the authors investigated short- and long term effects on motor function, cognition, affective state, and quality of life (qol) of gpi- and vim-dbs in myoclonus-dystonia (md). Ten md patients were evaluated pre- and post-surgery between 1997 and 2009. Both gpi- and vim-dbs are effective. There were fewer adverse, stimulation induced events with gpi-dbs in comparison with vim-dbs. There were 18 reversible stimulation-dependent adverse events (ae) in the vim group which resolved by adaptation of parameters; these include dysarthria, dysphagia, dysgeusia, worsening dystonia, headache, gait disturbance, dysaesthesias. There were 4 events experienced by the gpi group; these were nausea and phosphene. It was unclear which patients experienced which adverse event; however, no serious long-lasting stimulation-related ae's were observed. Reportable event: patient 8 of 10 received bilateral gpi and vim-electrodes; this patient experienced a reversible intracerebral hemorrhage less than or equal to 3 month's hemiparesis. The source literature did not specify which device models were used for the different patients. See literature article with mfr report# 3007566237201007967.

 
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible, several events occurred in one patient. At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872749
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dennis100
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« Reply #121 on: January 26, 2014, 03:10:19 AM »

Model Number 7428
Device Problem Connection issue
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: alcindor d, oh my, baser s, angle c. Cheng bc, whiting d. Stimulation of the globus pallidu internus in a patient with dyt1-positive primary generalized dystonia: a 10-year follow-up. Neurosurg focus. Aug 2010; 29(2):e16. Summary: in this case report, the authors describe a (b)(6) old man with dyt1-positive dystonia who underwent bilateral gpi dbs and report the 10-year safety and efficacy data. The patient had 10 left ipg changes on the more symptomatic side due to higher voltage needs and 5 ipg changes on the right over 10 years. Within 3 months of stage 1 surgery, the patient experienced a dramatic improvement; they were able to return to school and function independently. Minor symptoms experienced included mild dysarthria and a subtle rigidity while walking, none of which impedes daily activities. Reportable event: there were no significant complications, neurological deficits, infection/erosion, or system malfunctions. However, 4 years after initial ipg placement, the pt had increased rigidity and more cramping on the right side with the development of diaphoresis. In the left subclavicular ipg there were extremely high impedances, and chest radiography revealed disconnection of that generator. After revision surgery, these worsening symptoms resolved and the patient has had no further episodes of symptom recurrence.

 
Manufacturer Narrative
After 3 ipg changes in 13 months on the left side, a kinetra (7428) ipg was inserted. It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no add'l info was available, add'l info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885197
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dennis100
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« Reply #122 on: January 26, 2014, 03:11:53 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.

 
Event Description
Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229
« Last Edit: February 04, 2014, 03:46:38 AM by dennis100 » Logged
dennis100
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« Reply #123 on: January 27, 2014, 09:31:59 AM »

Model Number 37601
Event Date 08/09/2013
Event Type  Malfunction 

Event Description
It was reported the patient had their implantable neurostimulator (ins) replaced on the day of this report and they were shaking more than they were prior to implant. The reporter stated they were concerned that the patient¿s healthcare professional let the patient go home in that condition. The reporter further stated they were unable to use the patient programmer and did not know what needed to be done. It was noted the programmer showed 75% and ok. It was further noted the programmer showed stimulation was at 3. 09v and the patient was usually at 4. 3v and 4. 6v. Follow up information received from the healthcare professional (hcp) reported that the cause of the event was unknown and that impedances were normal. No surgical interventions had occurred and it was noted that the patient did not report any symptoms to the hcp regarding the event. It was unknown if hospitalization was required for the event. It was later reported that there was a loss of therapeutic effect. The patient was shaking and confused since the new implant was put in. It was noted that the patient was waking up in the middle of the night and asking questions about surgery that had already been discussed with the patient. The patient was scheduled for back surgery on (b)(6) 2013 and would be there for a little while. Patient was implanted but was not reprogrammed till a while later due to the patient being in and out of surgery. Patient had met with the manufacturing representative once and had some reprogramming done. The display was showing a ¿call your doctor¿ icon. There was an out of regulation (oor) condition. It was noted that when using the patient programmer to make changes was when the oor icon was showing up. Patient was unable to adjust stimulation. Additional information received reported the patient¿s battery was not turned on after battery replacement. It was noted that the manufacturing representative met with the patient and turned him back on with improvement in his tremor. Device was not related to the event. The date of the new implant was (b)(6) 2013. Patient was put back on his usual settings. Patient outcome was tremor improvement. It was noted that the date of onset was after the patient¿s rotator cuff surgery in (b)(6) 2013. Diagnostics were performed on (b)(6) 2013 and very high impedances were found at contact 1 on the left electrode. The cause of the issues was unknown though he had undergone shoulder surgery in (b)(6) 2013. Interventions taken were that the plus contact was switched from 1 to 2 on (b)(6) 2013. The patient had immediate improvement in right hand tremor and was requiring less voltage. Ins was changed in (b)(6) 2013. Patient had his l4 and l5 surgery on (b)(6) 2013 and was still recovering. Patient never had physical therapy for it and was doing arm exercises with more than the recommended 2 pounds. Since rotator cuff surgery the patient¿s right hand tremor had been worse. It was noted that the adjustment had helped some. It was noted that the patient was using a walker on (b)(6) 2013. Patient had normal facial expression, blink rate, voice volume w/mild tremor. Normal speed of gesticulations. The patient had minimal postural tremor in left hand and more prominent in the right and moderate. Trunk had some mild titubation exacerbated when standing or walking because of leg pain. Patient¿s gait with the walker was normal but had a decreased stride length and looked uncomfortable. It was noted that the night prior to this report the patient had shooting pain down his legs but no longer had that. Therapeutic impedance was high on left side. Postural tremor of right hand was minimal. Patient was able to hold a mug steady with minimal tremor after programming change. Left leg pain appeared better since the surgery on the day prior to this report. It was noted that since 2010 face/head injury and punch to abdomen and (b)(6) 2010 battery change the deep brain stimulator had never provided him with as good of relief as when initially implanted. It was noted that it was somewhat better after replacement on (b)(6) 2012. Patient felt it still was not as good as when it was initially implanted in 2006. Patient had various types of trauma that could have potentially damaged the deep brain stimulator. 0 contact was still best one after exploration of left electrode contacts. In the past the patient had some motor cramping/tightness on his left face and hand when his pulse width was increased to 90. On (b)(6) 2013 reported the patient went into the healthcare professional on (b)(6) 2013 with worsening of left leg pain. Patient had chronic back pain that had started about 10 years prior to this report. The patient had been in 5 motorcycle accidents and played hockey in high school with a number of hits and concussions. Patient also had concussions in his military years in his 20¿s. The patient¿s radiation of pain was more of a muscle spasm and cramping in the posterior and anterior thigh and had some numbness in the soles of both feet. There were no bowel or bladder problems. There was some tingling in the palms of his hands. There was no weakness in the hands or legs. The patient had some right shoulder issues felt to be the rotator cuff which had not been responsive to shots. Patient had been getting injections of l3/4 and l4/5 on the left and l5/s1 on the right and had been getting them for the past year prior to this report. Gates was mildly wide based and unsteady looking but was also painful when walking or standing. Patient was unable to relax legs. The patient had a mildly decreased vibration sense in the toes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530979
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dennis100
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« Reply #124 on: January 28, 2014, 04:43:12 AM »

Model Number 37602
Event Date 08/29/2012
Event Type  Death   Patient Outcome  Death,Disability
Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: 2012-(b)(4), product type implantable neurostim ulator product id 3389-40, lot# j0320077v, implanted: 2003-(b)(6), product type lead product id 748240, serial# (b)(4), implanted: 2003-(b)(6), product type extension product id 3389-40, lot# j0320077v, implanted: 2003-(b)(6), product type lead, product id 748240, serial# (b)(4), implanted: 2003-(b)(6), product type extension, product id 37642, serial# (b)(4), product type programmer, (b)(4).

 
Event Description
It was noted that the patient died. It was further noted that the healthcare professional (hcp) was concerned that the implantable neurostimulator (ins)/therapy might have exacerbated the patient¿s condition. Patient passed away in (b)(6) 2012. Additional information received reported the date of the patient death was (b)(6) 2013. Additional information received reported that device was not explanted.

 
Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3389-40, lot# j0320077v, implanted: (b)(6) 2003, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 3389-40, lot# j0320077v, implanted: (b)(6) 2003, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Event Description
It was reported that after the battery replacement the patient had deteriorated faster. The patient had needed a wheelchair following the change out whereas he was walking prior to the battery change out. It was noted that the patient¿s resting tremor was worse on the right side after the battery was changed out. Impedances greater than 40,000 ohms on left side were seen after battery change out, on (b)(6) 2012. It was noted that the patient had the same settings at the time of this report as they were prior to the change out. Therapy impedance was high and current draw was low. Patient was seen on (b)(6) 2012 again and impedances on the left side were still high. Patient was seen on (b)(6) 2012 and impedances were high on the left side. Additional information received reported no malfunctions were seen and no cause of the issue was determined. Reference manufacturer's report number: 3004209178-2013-23367 information omitted, see related pe¿s (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3513842
« Last Edit: February 04, 2014, 03:46:55 AM by dennis100 » Logged
dennis100
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« Reply #125 on: January 28, 2014, 04:44:10 AM »

Model Number 7428
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient was implanted on 2010 (b)(6) and after the operation, the patient could not walk. It was noted that the patient went to the hospital on 2012 (b)(6) and the health care professional advanced the electrode target for about 6mm. It was noted, the patient could then walk and after taking pills, the symptom improved. The reporter noted that the patient went to the hospital for programming. It was noted that the product remained for about two months. It was further noted that a programming had been arranged on 2013 (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3506469
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« Reply #126 on: January 28, 2014, 04:45:20 AM »

Model Number 7428
Event Type  Injury   Patient Outcome  Disability
Event Description
It was reported that the patient was implanted on (b)(6) 2010 due to parkinson¿s disease. It was noted that after the operation the symptom was well controlled. The patient fell in (b)(6) 2013 and then had difficulty walking gradually. Patient was reprogrammed on (b)(6) 2013 and after the programming the symptom improved. One month later the patient appeared to have difficulty walking, swallowing and could not care for himself. Patient was now taking pills. Patient was told the ¿product could remain to use although the product used faster. ¿ additional information received reported the effect of programming was good but one month later the symptom existed. It was unobtainable as to whether any malfunctions were see or cause of issues determined. It was unobtainable whether interventions were taken or planned. Patient walking difficulty was aggravated, had difficulty swallowing, constipation and could not take care of himself.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3519346
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« Reply #127 on: February 07, 2014, 12:18:42 AM »

Model Number 37612
Event Date 12/31/2013
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension (b)(4).

 
Event Description
It was reported, the patient had one side of the deep brain stimulator (dbs) turned on 2013 (b)(6) and the patient was doing ¿very very well¿ and they could understand when the patient talked and the patient could talk perfectly. It was stated, the patient¿s second side was turned on 9 days prior to report and ever since then the patient had problems. It was noted, the patient was stumbling and they used a walker to help them and they had an awful time navigating. It was stated, the patient would babble. It was noted it was hard to understand the patient. It was stated, the patient would babble and it ¿was like the patient had a stroke. ¿ it was stated they did not think the patient had a stroke. It was stated when the second side was turned on the patient fell at the health care professional¿s office. It was stated, the patient was weak and falling again. It was noted, the stimulation was turned down until the patient felt better and steadier on their feet and would not stumble. It was noted, the patient programmer did not have the ability to increase stimulation but only decrease. It was further reported, the cause of the event was possible effect of the programmer 1-2 weeks after the patient was seen. It was stated, the patient had fallen and tore their rotator cuff. It was noted, the patient fell 1-2 weeks after reprogramming of the dbs. It was stated, the patient was ¿all over the place¿ with movements on their right side and problems with speech, balance, and hallucinations. It was stated, the patient as seen by their family physician on 2014 (b)(6) who had questioned whether it was untoward affect from dbs and or the medication. It was stated, the patient¿s left side settings were decreased. It was noted, the patient¿s medication was also discontinued. It was stated no x-rays were performed. It was noted, the patient as to be seen on the day of report for reprogramming but it was cancelled due to poor weather. It was stated, the wife had rescheduled the appointment for 2014 (b)(6). It was noted the symptoms of jerky movement and affected speech had resolved. It was stated symptoms associated with the event were hyper-movement of left side, speech decreased, and hallucinations. It was stated, the patient sustained torn rotator cuff after fall. It was noted, the patient outcome was non-serious injury or illness. It was stated 2014 (b)(6), the patient was doing well. It was stated, the patient was able to feed themselves. It was stated the patient dressed with minimal assistance and they could put their jeans on. It was noted their speech improved and they were mentally clear. It was stated the patient had a walker that they would use inconsistently.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595012
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« Reply #128 on: February 07, 2014, 08:48:00 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative
Product id 37602, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 748351, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# unknown, implanted: 2013 (b)(6); product type lead product id 3387s-40, lot# va01mbs, implanted: 2012 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

 
Event Description
It was initially reported (b)(6) 2013 that therapy had been effective in treating the patient¿s tremors but it made walking more difficult. The patient was very disappointed with the results of deep brain stimulation therapy and since having her first implant on 2012 (b)(6). The patient has had difficulty walking without a walker and after the second implant on 2013 (b)(6) the difficulty walking got worse. The patient had 4 falls yesterday and fell almost every day. It was noted, the patient was taking less medicine and her health care provider (hcp) considered therapy a success. It was later reported on (b)(6) 2013 that the patient had ¿bad¿ results with the device therapy for parkinson¿s. She falls ¿all the time¿ and she was ¿very unstable¿. The patient wanted a list of physicians since her hospital did not seem to want to change her programming. It was further reported that the patient was still having concerns but was working with her hcp/company representative. The patient had an upcoming appointment on 2013 (b)(6). Additional information received reported the patient never had therapeutic effect. The patient was disgusted with the results of her deep brain stimulation (dbs) procedure; she was disgusted that her condition did not improve and it got worse. The patient could hardly walk, could not stand up, and her voice was bad. The patient walked into surgery and was now in a wheelchair. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3555091
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« Reply #129 on: February 07, 2014, 08:52:12 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/19/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Issar, n. M. , hedera, p. , phibbs, f. T. , konrad, p. E. , neimat, j. S. Treating post-traumatic tremor with deep brain stimulation: report of five cases. Parkinsonism <(>&<)> related disorders. 2013;19(12):1100-1105. Summary: post-traumatic tremor is one of the most common movement disorders resulting from severe head trauma. However, literature regarding successful deep brain stimulation (dbs) treatment is scarce, resulting in ambiguity regarding the optimal lead location. Most cases support the ventral intermediate nucleus, but there is evidence to defend dbs of the zona incerta, ventral oralis anterior/ posterior, and/or a combination of these targets. We report five patients with disabling posttraumatic tremor treated with dbs of the ventral intermediate nucleus and of the globus pallidus internus. Patients were referred to the vanderbilt movement disorders division, and surgical intervention was determined by a dbs multidisciplinary committee. Standard dbs procedure was followed. Patients 1e4 sustained severe diffuse axonal injuries. Patients 1e3 underwent unilateral ventral intermediate nucleus dbs for contralateral tremor, while patient 4 underwent bilateral ventral intermediate nucleus dbs. Patients 1e3 experienced good tremor reduction, while patient 4 experienced moderate tremor reduction with some dystonic posturing of the hands. Patient 5 had dystonic posturing of the right upper extremity with tremor of the left upper extremity. He was treated with bilateral dbs of the globus pallidus internus and showed good tremor reduction at follow-up. Unilateral or bilateral dbs of the ventral intermediate nucleus and bilateral dbs of the globus pallidus internus may be effective and safe treatment modalities for intractable post-traumatic tremor. Further studies are needed to clarify the optimal target for surgical treatment of post-traumatic tremor. Reported event: one (b)(6) male patient with deep brain stimulation (dbs) for post-traumatic tremor experienced moderate tremor reduction with some dystonic posturing of the hands. The reporter stated that the patient experienced stimulation-associated side effects including some dystonia movements of the upper extremities, gait instability, balance difficulties, paresthesias, ataxia while walking, and slurred speech. The reporter stated that the patient experienced decreased tremor control and increased impedance between six and 33 months after dbs implantation. It was noted that the patient underwent exploration and interrogation of the dbs system with replacement of the extension wires, which resulted in significantly improved tremor reduction. The patient reportedly continued to have some dystonic posturing of both hands while performing fine motor tasks. The reporter stated that the continued dystonic side effects may require consideration of additional leads in the globus pallidus internus (gpi) for increased tremor reduction. 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=3571891
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« Reply #130 on: March 28, 2014, 12:41:25 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id: 3389s-40, lot# va0753z, implanted: (b)(6) 2013, product type: lead. Product id: 3389s-40, lot# va0753z, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer. Patient product id: 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

 
Event Description
It was reported the patient experienced a loss of therapeutic effect; her tremors were okay but her handwriting had gotten worse which started in the last month or so. The patient¿s husband was told by the patient¿s physician that he could increase the voltage. It was noted the patient had developed lung cancer. Additional information received; approximately 2. 5 weeks later reported, the patient wanted to increase stimulation. The patient¿s husband saw ¿2. 10 then some bars and then 0. 80. ¿ he then saw 2. 99 volts after going to the navigator keypad. It was noted the patient was having problem on both sides. Additional information received reported that the patient was reprogrammed and was a lot better but were going in again to have it tweaked a bit more. The reporter noted there was no device issue. The patient was doing well. It was reported that the patient just had the device reprogrammed and wanted to know how to change groups. Basic functionality of the device was reviewed. The patient changed groups and stated out loud that there was ¿a tingling¿ in their hands. The patient wanted the manufacturing representative to stay on the line until it stopped. After a moment, the patient stated it was ¿calming down. ¿ the patient noted that they would try the setting. It was later reported that the patient had the deep brain stimulator for essential tremor and ¿it had worked great for what it was put in for. ¿ the patient was having some ¿side effects. ¿ the patient had terminal lung cancer. It was noted that the patient ¿she could not walk¿ if the implantable neurostimulator (ins) was on. If the ins was turned off and back on the patient got a shock and the patient had been told that this normally did not affect muscle control until a voltage of 6. It was noted that the patient was at 2. Several months prior to the date of this report, may be in (b)(6), the patient had reprogramming session that had taken 1. 5 hours. The patient had been absolutely exhausted after that. Patient¿s motor control had gotten worse since then. The patient had fallen 3 times on tuesday prior to the date of this report, once the day prior to this report and once the wednesday prior to the date of this report. It had created a problem with her foot and the patient was in a boot. Symptoms had occurred several months prior to the date of this report. The patient had seen the healthcare professional 2 weeks prior to the date of this report and after he had found out about the lung cancer he said to turn the ins off if it did not work. Patient¿s husband stated that ¿we know it was caused by the device. ¿ additional information was requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3647137
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« Reply #131 on: March 28, 2014, 12:42:59 PM »

Model Number 7428
Event Date 06/15/2013
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported, the patient had been implanted on (b)(6) 2013 to treat parkinson's disease. On (b)(6) 2013, the patient went to the hospital for reprogramming due to "leg ache and weakness", and difficulty to take a step and falling down easily. It was reported on (b)(6) 2013, the patient fell down and fractured a hip, so the patient went back to the hospital for treatment. It was reported, the patient had a limb tremble on (b)(6) 2013, and went back to the hospital for reprogramming and that improved the symptom (limb tremble). It was noted the difficulty taking steps and falling down easily were not improved. It was reported, the patient's health care provider (hcp) indicated the target spot "deviation by mri checking". Additional information reported it was unknown if the patient had any further troubleshooting done.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3611043
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« Reply #132 on: March 28, 2014, 12:43:45 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id: 7436, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Event Description
It was reported in (b)(6) 2013 the patient had experienced a cerebral hemorrhage. It was noted after the event the patient had experienced a ¿lisp, dribble automatically, and movement inconvenienced. ¿ it was noted on (b)(6) 2014 the patient had tried to turn on the product but the patient found there was no alarm sound when they clicked open the bottom. On (b)(6) 2014 e1a (rep): it was further clarified the patient continued to have dribbling, a lisp, and walking difficulty when they would try to move.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3636927
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« Reply #133 on: March 28, 2014, 12:44:35 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported the patient had their first programming episode in the doctor¿s office and they had a good response with mobility but they also complained of nausea. It was noted the patient had a lot of nausea, discomfort, and ¿lots and lots of dyskinesia,¿ especially freezing and ¿hypernicity. ¿ it was noted the health care professional (hcp) ¿backed it way down again¿ and then incremented it up but the side effects never went away. It was stated the patient¿s nausea and abdominal fullness and gassiness got worse and worse. It was noted the patient saw their hcp on (b)(6) 2013. It was noted they had tried several different sites. It was noted at the beginning of (b)(6) 2014 the patient did not have any dyskinesia but their movement ¿wasn¿t terrific and they still had a lot of freezing, horrendous gastroparesis, bloated stomach, intestinal bloating after eating, miserable all of the time, and they constantly tried to have a bowel movement. ¿ it was noted the hcp did not think the vagus nerve was stimulated. It was noted after the patient took their medications, they had very slurred speech ¿like they were drunk¿ and they could barely walk. It was stated all of the patient¿s symptoms had gone on since (b)(6) 2013. It was stated the patient had constipation. It was noted the patient saw their hcp about every two weeks to adjust programming but it did not work well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3626743
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« Reply #134 on: March 28, 2014, 12:45:36 PM »

Model Number 3387S-40
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va0e81e, implanted: (b)(6) 2013, product type lead. (b)(4).

 
Event Description
It was reported the patient had meningitis following deep brain stimulation (dbs) lead implant in december. The patient presented at the hospital today with increased confusion and impulsivity. The patient was in a rehabilitation unit and was struggling. He went home and had a bunch of falls, was unoriented and he did not know where he was. It was noted the patient last saw his implant physician yesterday. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available. Refer to mfr report # 6000153-2014-00022 for the patient's other lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3629391
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« Reply #135 on: March 28, 2014, 12:46:46 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 37602, serial # (b)(4), implanted: (b)(6) 2011, product type implantable neurostimulator; product id 3387s-40, lot # v015069, implanted: (b)(6) 2007, product type lead; 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 3387s-40, lot # v015069, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension. (b)(4).

 
Event Description
It was reported that after the patient¿s implantable neurostimulator (ins) was changed she immediately had trouble with her ¿left¿ ins. Within three months of the change out her movement disorder was ¿horrible. ¿ the patient recently visited a healthcare provider (hcp) who told her the ins had not been turned on for some time. The patient was doing tae kwon do prior to the change out, but was now confined to a wheelchair. The patient also stated that there was one instance where she was in the hospital and a manufacturer representative came out to look at her programming. This occurred somewhere between (b)(6) 2011. The representative activated the correct program and the therapy worked as expected for a while. When the therapy stopped working again recently, the hcp assumed there was another lead problem. Two days later it was reported that three months after replacement ¿something got worse and it was on the wrong channel. ¿ the patient then stated that the battery was dead and being replaced the day after the report. The neurosurgeon needed to see that the other battery was active and functional. Two days later it was reported that the reporter spoke to the patient over the phone and believed that after the replacement surgery in 2011 the batteries were not ¿renumbered. ¿ the reporter stated that another representative might have met with the patient and ¿numbered¿ the battery and reprogrammed, which resulted in her receiving effective therapy. When the reporter spoke to the patient on (b)(6) 2014 she only mentioned that she wanted her therapy resumed and no other issues. The reported believed that the batteries were either on end of service (eos) or elective replacement indicator (eri) so they just need to be replaced and was hopeful that would resolve the therapy issues. Additional information was requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3642714
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« Reply #136 on: April 10, 2014, 05:12:00 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that a patient¿s stimulation was ¿shutting down¿ and he was not feeling any benefit. It was noted that therapy stopped two days prior to the report. The reporter stated that the patient programmer was displaying ¿call your doctor¿ and out of regulation (oor). It was reported that the patient saw the message the previous evening and had contacted the doctor, who wanted to see the patient but not until (b)(6) 2014. It was noted that the patient tried the programmer and it was working. The patient saw ¿yes¿ and ¿ok¿ after pressing the check key and saw the lightning bolt. It was reported that the patient couldn¿t feel anything and usually felt stimulation. It was noted that the patient asked if one of the leads was broken. Two days later, it was reported that the patient wasn¿t able to adjust stimulation and there was an oor condition. It was noted that a manufacturer representative was asked to see the patient to evaluate the impedance reading. The left side showed 924 ohms and 7. 27 milliamps, and the right side showed 3030 ohms and 2. 243 milliamps. It was reported that the doctor interrogated the device and did not see any oor or other message on the clinician programmer. It was noted that the oor message was seen during the weekend when a cat walked or jumped across the patient¿s chest. It was reported that electrode 7 showed higher than the normal 1000 ohms and higher, but the patient was not using that electrode. On the right side, the patient was programmed with case positive, 6 negative at 6. 8 volts, 120 pulse width and 120 hz and rechecking therapy impedance showed 3014 ohms and 2. 255 milliamps. On the left side, the patient was programed with 1 positive, 2 and 3 negative at 6. 8 volts, 90 pulse width, and 120 hz and rechecking therapy impedance showed 924 ohms and 7. 273 milliamps. It was reported that the day of the report when the device was interrogated, the oor message was not seen. It was noted that the implantable neurostimulator (ins) was last charged on (b)(6) 2014, the battery showed 75 percent charge the day of the report, and the ins battery was lasting longer than before. It was reported that before the patient needed to charge every two days. The reporter stated that the patient was part of a voice study and had turned the stimulation off for an hour last week. It was noted that the patient had been keeping stimulation on, he was wheelchair bound, and he had been unable to walk since saturday. It was reported that the ins battery was at 3. 9 volts and impedance readings were the same with palpation or neck turning. Five days later, it was reported that there was an open circuit on the right lead and on (b)(6) 2014 there was a return of symptoms, the device was checked and it was turned off and at 20 percent charge. It was turned back on and charged fully. It was noted that there were no problems charging and it was charged to 100 percent. It was reported that a healthcare provider (hcp) verified that the device was on and charged but it didn¿t appear that the patient was getting any therapeutic response. The medical workup was negative and all impedances with electrode 7 appeared to be greater than 10,000 ohms. It was noted that the last therapy impedance done in (b)(6) was 791. The reporter stated that there was a possible open and medically they could not program with electrode 4. It was reported that they couldn¿t program around it and there was a possible revision. It was noted that the amplitude had always been around 6. 8 volts. A week later, it was reported that the cause of the event was unknown and was presumably attributed to the ins. It was noted that therapy impedance on the right hemisphere increased from 900 to 3000. It was reported that the ins issue was unknown and it was not delivering therapy. It was noted that an x-ray and ct scan on (b)(6) 2014-02-25 were normal and a time for ins replacement would be determined. Symptoms associated with the event included acute worsening of parkinson¿s disease symptoms and the patient didn¿t require hospitalization. It was reported that the event was ongoing and the patient symptoms were still not controlled until surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3671177
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« Reply #137 on: April 10, 2014, 12:44:41 PM »

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

 
Event Description
It was reported that the patient was implanted on the other side in (b)(6) 2012 and the right body trembled was not able to be controlled after the product was turned on. It was noted that the patient had gone to the hospital for reprogramming in (b)(6) 2012 but the right tremble had not improved. Patient had never gone to reprogramming later. The patient was now lying on the bed and was not able to walk or take care of herself. Additional information received reported the patient had never gone to the hospital for reprogramming after (b)(6) 2012. It was unobtainable if any further troubleshooting was done of if any actions had been taken.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3663411
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« Reply #138 on: May 11, 2014, 06:21:36 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that the patient experienced acousma before implantation. It was noted that the after implant the patient experience d ¿an intensity, doubtful, talk nonsense, walking quickly, and sound low. ¿ it was noted that a ct scan on 2014-(b)(6) showed that the patient effect was well and the patient was given some psychoactive drug. It was noted that on 2014-(b)(6) the patient went to a psychiatry clinic and the health care professional (hcp) there also gave some psychoactive drug and the effect improved. It was noted that on 2014-(b)(6) the patient did not recognize the family member and had gatism. It was noted that there was no patient injury or death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3721809
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« Reply #139 on: May 11, 2014, 09:39:30 PM »

Model Number 37601
Event Date 03/20/2014
Event Type Injury Patient Outcome Life Threatening
Event Description
It was reported the patient had their second deep brain stimulator (dbs) adjusted the day prior to report and the reaction to the programming had caused the patient to have walking issues and issues with their personality. It was noted they wanted to know if the use of a digital hearing aid was okay. It was noted the personality issues were specified as they ¿did not want to live and they wanted to kill themselves. ¿ it was stated the patient had gone back to their doctor¿s office on the day of report and the settings were turned back to how they were prior to the adjustment and the amplitude was also increased. It was stated the programming adjustment on the day of report had resolved the personality issues.
Manufacturer Narrative
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: 37642, serial# (b)(4), product type: programmer. Patient product id: 3389s-40, lot# va0bjs5, implanted: (b)(6) 2013, product type: lead. Product id: 3389s-40, lot# va0bjs5, implanted: (b)(6), product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3743947
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« Reply #140 on: May 12, 2014, 02:58:50 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).
Event Description
It was reported the patient¿s deep brain stimulation (dbs) device was implanted (b)(6) of 2012 and they could never program it. The leads were implanted and ten days later they put the battery pack in and they waited another ten days before they turned it on to program it. The patient¿s healthcare provider (hcp) could not figure out why on the lowest setting the patient could not talk, his left arm would come up to his chest when he would walk and his right shoulder kept twitching or spasming. From the time it was implanted the device did not really function for the patient; every time they turned it on and gave him medications to try to control the dyskinesia it did not work and this was after a year of oral medication. It was noted the patient was dyskinetic the entire time the device was implanted. It stayed in for about a year until they could not figure out why or what was going on. Every time the patient turned it on ¿patient shoulder would, he was falling three times a day. ¿ the patient fell in his house and broke his ribs the last saturday in (b)(6) 2012. The patient¿s dbs device was turned off and he was better but he still had some of the dyskinesia and had tremendous headaches. In (b)(6) of 2013, the patient had his device removed as he could not handle it anymore. The patient was sure there was a short circuit or something like that which caused the dyskinesia. It was reported the patient thought the leads down in the globus thalamus would not do that, he understood it may affect his speech, but not the rest of it. It was reported the device was leading to such headaches and such problems; he had a big bony growth behind his ear in his skull which was occurring during the entire time the device was implanted. After the device was removed those symptoms went away. Additional information received two weeks later reported somewhere around the second week of (b)(6) 2012 the patient was in severe dyskinesia one night and he could not turn it off. He did not know what was going on and he finally got in touch with a manufacturer representative from (b)(4) who walked his wife through turning his device off. It was also reported the patient¿s unit did not come out easily, the leads and all that stuff did not come out easily. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3745721
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« Reply #141 on: June 07, 2014, 10:13:17 AM »

Model Number 37612
Event Date 02/20/2014
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
(b)(4).
Event Description
It was reported that there were 1-2 bad electrodes isolated to one side of a bilateral deep brain stimulation (dbs) system. The patient was recharging often and there was high current drain with low impedance. The manufacturer¿s representative had met with the patient the day prior to report to perform impedance testing. Electrode impedances were as follows: c/0 745, c/1 734, c/2 952, c/3 1080, 0/1 44, 0/2 844, 0/3 1125, 1/2 844, 1/3 1125, 2/3 1035. The patient was currently in the hospital for bad gait and speech problems. The patient had been hospitalized for 10 weeks. Extensive reprogramming had been performed by the neurologist and only programming electrodes 0 and 1 seemed to help the patient. The patient was programmed on the shorted contact. It was stated that the patient¿s system was fine prior to hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3830617

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« Reply #142 on: June 07, 2014, 10:14:18 AM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported on (b)(6) 2014 that the patient had a loss of therapeutic effect that started suddenly ¿about three weeks ago. ¿ the reporter stated that the patient ¿all of a sudden was not walking well. ¿ the patient was taken into the clinic to check his system and it was determined that the implantable neurostimulator (ins) was not delivering any stimulation to the contacts. X-rays of the lead and extension were taken, but no issues were found. Left ins replacement was scheduled and completed. The patient was doing fine with no issues.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3824787
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« Reply #143 on: June 07, 2014, 10:15:14 AM »

Model Number 7426
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported, the patient was not able to use their hands. It was noted, the patient had pain, tingling, and numbness in their hands. It was stated, they had no mobility in their left hand and the left hand was worse than the right. It was noted, the condition had gotten progressively worse since (b)(6) 2013. It was stated they were unsure if the deep brain stimulator (dbs) still worked as it had been 4 years since their last battery change. It was noted they cortisone in their left hand at one time but it did not help. It was noted, the patient¿s condition ¿may not be due to the instrument itself. ¿ it was further reported, the patient had a loss of therapeutic effect. It was noted, the patient had fallen more than usual. It was stated in (b)(6) 2013, the patient had started to fall a lot but that was because they weren¿t taking one of their medications. It was stated when the patient got back on the medication their walking got better but in the last few weeks or months prior to report the patient¿s walking had gotten worse. It was noted, the patient had a magnetic resonance image (mri) performed on one of their arms a couple of months prior to report. It was further reported, the patient had a surgery the day prior to report to replace their batteries.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3796324
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« Reply #144 on: July 04, 2014, 10:24:11 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2007 (b)(6), explanted: 2013 (b)(6); product type implantable neurostimulator product id 7426, serial# (b)(4), implanted: 2007 (b)(6); product type implantable neurostimulator product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 3387-40, lot# j0214131v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 7438; product type programmer, patient product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0214131v, implanted: 2002 (b)(6); product type lead. (b)(4).
Event Description
It was later reported that the patient was not doing well. The patient was ¿doing the same falling. ¿ patient loses her balance, crosses her feet and her legs freeze causing her to fall. It was noted that this had been going on for ten years prior to the date of this report. The patient would fall 2 or 3 times a day. It was noted that as a result of the falls the patient had had to have knee replacements and knee cap surgery. The patient had a walker but if she had to grab or anything she fell. It was noted that when the first implant was put in 2002 it had helped with her walking. The battery was replaced in 2007 and it ¿did good¿ for about a week and then the patient all of a sudden started having trouble walking. In 2013, one of the batteries was replaced but the other had shown no wear and it was unknown how or why. The device did help with the patient¿s tremors. The patient did not know if she wanted the lead fixed because, she had been in the hospital for 2 weeks and spent 3 months in a nursing home recovering. It was noted that the right battery was the one that was replaced in 2013 and the left was the one that had shown no use, left battery was like brand new. Reference manufacturer¿s report number: 3004209178-2012-10670.

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« Reply #145 on: July 04, 2014, 10:24:53 PM »

Model Number 37612
Event Date 09/24/2013
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the patient was implanted with a deep brain stimulator on 2013-(b)(6). After the operation, the patient had poor therapeutic effect and had difficulty walking. The patient wanted the device reprogrammed. Additional information indicated that the physician found that the target point of the lead was too deep. A second surgery occurred on 2014-(b)(6) to adjust the position of the lead. Following surgery, the patient¿s symptoms were improved, but after ten days the symptoms returned. Further information indicated that no additional action had been taken since the patient¿s symptoms had returned, and no action was planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899589
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« Reply #146 on: July 05, 2014, 12:33:13 AM »

Model Number 7426
Event Type Injury Patient Outcome Other
Event Description
It was originally reported on (b)(6) 2014 that the patient¿s knees had been ¿collapsing on him for about a week,¿ but the main issue was that he had trouble getting back up. The patient had trouble walking, but the reporter noted, he always had trouble with balance. The reporter wanted to check the patient¿s implants to make sure they were working. Both sides showed ¿on and okay. ¿ about a month later, it was reported that the cause of the event was cognitive issues and disease progression. An infection workup was negative. The patient had hallucinations and was delusional. The patient was wandering in his home and had a few falls due to knees buckling. This was not a new issue and the patient was started on quetiapine. No hospitalization was required and the patient outcome was marked as no injury.
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2010 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0527242v, implanted: 2005 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2005 (b)(6); product type extension product id 3389-40, lot# j0527242v, implanted: 2005 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2005 (b)(6); product type extension product id neu_unknown_prog, serial# unknown; product type programmer, physician. (b)(4).

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« Reply #147 on: August 11, 2014, 01:17:30 AM »

Model Number 37601
Event Type Injury Patient Outcome Hospitalization
Event Description
It was reported that there was a loss of efficacy which was unrelated to stimulation therapy. Patient¿s current battery voltage was 2. 66v. In the past few months prior to the date of this report, the patient had been having issues with freezing and gate issues. A longevity calculation was performed to estimate the battery life of the implantable neurostimulator (ins). Based on the current settings the ins would last 9. 5 months and the patient was implanted 18 months prior to the date of this report. There was 100% usage. There were no known falls or traumas. The patient used a walker and may have fallen and not reported. The ins had seemed to be moving further down. It was unknown if it was loose in the pocket as it was sutured to fascia. The patient was in the hospital for the past few days prior to the date of this report which involved some anxiety along with other possible deep brain stimulator related issues, stiffness and ankle swelling. Patient had contacted the healthcare professional in (b)(6) to be seen, patient was seen on (b)(6) 2014. Healthcare professional had requested patient come back in for more diagnostic testing before replacing the ins. Patient had control but could not tolerate the increased amplitude. The patient was trying to increase to alleviate the freezing and gate issues. Patient¿s current settings were 5. 1v amplitude, rate was 170hz, pulse width was 90 and impedance was 1630 ohms. It was later reported patient had recently had some medical symptoms which were concerning but which may not be related to the deep brain stimulator therapy. Extensive impedances were run and all impedances were normal. Program 1 was at 5. 0v, 90pw, 170hz, and 1033 ohms. Program 2 was at 5. 1v, 90pw, 170hz, and 1611 ohms. It was noted that at those parameters, the ins would last about 19. 19 months. The ins seemed to be at the appropriate charge level based on the information. There was no longevity complaint. Patient was having an mri and it was part of the medical work up and they did not suspect deep brain stimulator failure/malfunction considering the longevity estimate.

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« Reply #148 on: August 11, 2014, 07:53:59 AM »

Model Number 7426
Event Date 06/04/2014
Event Type Injury Patient Outcome Other
Manufacturer Narrative
Concomitant medical products: product id 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator; product id 3387-40, lot# j0406144v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 7438, serial# (b)(4), product type: programmer, patient; product id 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension; product id 3389-40, lot# j0225447v, implanted: (b)(6) 2002, product type: lead. (b)(4).

Event Description
It was reported that the patient had seizure like symptoms when the manufacturer representative left on the day of the report. The reporter noted that the patient had an implant replaced due to battery depletion and he may have been overstimulated at the time of the report. Additional information was requested, but was not available as of the date of this report. Refer to manufacturing report #300420917 8-2014-12534 as the patient had dual implants and it was not specified which ins was the issue.

Event Description
Additional information received reported that the patient was seen on (b)(6)-2014 for normal programming. The battery was tested and within normal limits of voltage, the leads were found to be fine, and the device was working as expected. The patient did present with gait issue, facial pulling, and finger tapping; all of which were much improved with reprogramming. There was no mention in the patient¿s file of any seizure or seizure like activity reported by the patient or anyone else. As far as the doctor¿s office was concerned the patient was experiencing therapeutic effect and the system was working as designed and intended.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913995
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« Reply #149 on: September 06, 2014, 12:59:00 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.

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