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Author Topic: Deep brain stimulator - Legs  (Read 42600 times)
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dennis100
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« Reply #30 on: January 12, 2014, 06:16:13 PM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: piboolnurak et al. "levodopa response in long-term bilateral subthalamic stimulation for parkinson's disease" movement disorders/2007/22/7/990-997. This article describes a long-term follow-up of 33 pts with dbs therapy for parkinson's disease. Reportable event: there was a total of 2 adverse event reports of restless leg syndrome during the follow-up. No add'l info or outcomes were provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015659
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dennis100
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« Reply #31 on: January 12, 2014, 06:17:02 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: tir et al. "exhaustive, one-yr f/u of subthalamic nucleus deep brain stimulation in a large, single-center cohort of parkinsonian pts. " 2007/61/2/297-304. This article describes a study that enrolled consecutive pts with parkinson's disease who were treated with bilateral stn-dbs. The pts were followed for a period of 12 mos. Reportable event: two pts experienced a pulmonary embolism secondary to leg phlebitis. Good outcomes were achieved with the use of anticoagulation therapy.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019054
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dennis100
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« Reply #32 on: January 13, 2014, 01:56:40 AM »

Model Number 3387
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 06/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that in 2007 while the stimulation was on, the patient experienced a headache and numbness in her legs and arms. There was no known accident or incident related to the symptoms. The patient was currently at home and had an appointment with her hcp. Additional information has been requested from the hcp, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045939
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dennis100
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« Reply #33 on: January 13, 2014, 01:58:10 AM »

Model Number 7426
Device Problems Battery failure; Replace; No telemetry
Event Date 12/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported in 2007, that the implanted device could not be interrogated using the pt programmer; the pt's wife had confirmed that only the 9v battery light would illuminate. There were no symptoms reported and the rep redirected the pt to follow up with the physician. It was reported in jan 2008, that the pt had visited the hcp regarding the event (follow-up dates were not provided). The device had not been reprogrammed and problems with the implanted system were ongoing. Results of a brain ct scan in 2007, shows tissue atrophy and a lead is noted in the left ventricle. The rep had interrogated the system (date of exam was not reported), and found the pulse generator battery depleted. The pt had experienced symptoms of increased tremor and muscle stiffness in the right leg and the pulse generator was replaced for battery failure. The pt had recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1030852
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dennis100
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« Reply #34 on: January 13, 2014, 01:59:11 AM »

Model Number 3387
Device Problem Implant, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: linhares; protocol of procedure in deep brain stimulation for treatment of parkinson disease/sinapse /2007/7/1/23-27: this paper describes a clinical study of dbs for treatment of parkinsons disease and attempts to put a standardization to the procedures and outcome measures. One pt experienced a intracerebral symptomatic hemorrhage during the procedure that resulted in grade 4/5 lower limb paresia. One pt experienced a system infection after rejection of the material and cutaneous exposure. One pt had a serious case of depression which led to repositioning of the electrode. Mfr was not identified.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026785
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dennis100
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« Reply #35 on: January 13, 2014, 08:33:34 AM »

Model Number 3389
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The spouse had reported on 11/07, there had never been therapeutic effect when stimulation therapy was turned on, the pt's symptoms had improved (he was better), with stimulation turned off. The hcp provided summary notes for pt follow-up between 2 months in 2007, timeframe. All impedance checks in 2007, has been normal (exact values were not provided), the unilateral dbs system had been reprogrammed several times without improvement. Symptoms of neurological deficit was described as "freezing. " the pt was seen in 2007, for initial reprogramming after dbs placement. Initial settings were 1-, case +, 2. 0 v, 90 unsec. When the voltage was turned up to 2. 5 v the pt had "slight skewed diploia. " subsequent settings were 2-, case +, 2. 0 v, 90 unsec, which caused a "dramatic reduction in dyskinesia. " a follow-up 3 days later, the pt had improved and his medications lasted 2. 5 to 3 hrs, versus 2 hrs. It was noted when medications wore off the pt had difficulty walking; he would freeze and would either hop from place to place, to break the freeze, or he would lean into furniture and drag his legs behind him. When the medications worked, he had dyskinesia. The pt omitted levodopa prior to exam; he had no dyskinesia, his speech was clear and he had not seemed distractible or inattentive. There was mild upper extremity and mild to moderate lower extremity rigidity; he had obvious freezing upon initiating and maintaining gait. The pt could not walk effectively for more than a few feet. During reprogramming, setting were 2-, case +, and the voltage was increased from 2. 0 to 3. 0 v, initially keeping the pulse width at 90 usec with no change seen in tone, bradykinesia, or freezing. When the pulse width was widened to 120 usec, the pt's speech became muffled; he had appeared less attentive while conversing and the pulse width was returned to 90 usec. The pt took his medications, which then showed mild right-sided and moderate to severe left-sided dyskinesia, his gait had been normal with good stride length and balance, with stimulation on. At follow-up on 09/21/07, the pt had suffered a fall that required sutures (no details were provided). Settings at 2-, case +, 3. 0 v, showed some on freezing, his gait became worse when off. Settings of 2-, case +, 3. 5 v, still showed on freezing with improvement. Additional settings of 1+,2-, 2. 0 v, 90 usec, and 185 hz showed no obvious on freezing, there was some residual freezing but his medications appeared to be effective for a longer period of time. The pt would discontinue comtan. Approx 2 weeks later, the pt was seen for "further dbs titration"; symptoms of moderate left-sided and mild right-side dyskinesia were noted. Upon initiating gait, there was slowness to move the right-foot and slight freezing in the right lower extremity (rle). When settings changed from 2. 0 to 2. 5 v, the pt showed significant freezing of the rle upon walking. The voltage was increased to 3. 0 v, and the freezing became worse; subsequently the voltage was decreased to zero and freezing appeared to improve. The anode and cathodes were reversed to (1-, 2+), at a setting of 2. 0 v, and 90 usec, which showed improved gait. The pt was discharged at 2. 0 v, and was referred to physical therapy. A follow-up about 2 weeks later, the pt continued to have difficult freezing, which occurred prominently between doses of levodopa, but had also occurred while on levodopa medication. The symptoms were deemed to be a "side effect of dbs off freezing," which had been less prominent pre-operatively, the on freezing was new. On exam he had moderately severe left-sided and mild right-side dyskinesia; freezing was noted upon gait initiation. His speech was normal. Dbs therapy was inactivated; voltage was set to 0 v and the device was turned off. The pt anticipated travel in the following month. Refer to mr report #3004209178200704569.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006019
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dennis100
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« Reply #36 on: January 13, 2014, 10:54:20 AM »

Model Number 3387
Device Problems Performance; Device remains implanted
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that following stage 1, bilateral lead placement in 2007, "they had noted a change in the patient". The physician indicated the patient had suffered a stroke (the exact date of onset was not reported); the event had been attributed to the lead device. The patient had been seen for one post-operative visit with the surgeon (exact date was not given). The patient had hemiplegia; it was unknown which side had been affected. She had received short-term rehabilitation (dates and type of facility were not provided), and had subsequently been discharged to home. The patient's condition was non-ambulatory; she had been able to walk prior to the surgery. The patient reported in 2008, that the system had been reprogrammed in 2008. No symptoms had been provided but the patient stated that after reprogramming "it helped for a short while". There had been painful right leg spasms, that had occurred whenever she sat down. She had tried increasing her parkinson's medications and achieved symptom suppression for a few hours before spasms would return. At follow-up for programming the following month, the hcp stated that the patient had been responding well to treatment but at times does have symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1013780
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dennis100
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« Reply #37 on: January 14, 2014, 11:25:43 AM »

Model Number 7426
Device Problems Replace; Inappropriate shock
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
When the pt turned his stimulation on he experienced a shocking sensation in the right side of his body which lasted 5-7 seconds. It started in his right arm, traveled through his body to right leg and toes, and then disappeared. The symptoms coincided with the car crash. The pt did not feel the shocking after switching to a different pt programmer. The pt also experienced shocking on his left side (see mfg report # 3004209178200805581). The bilateral pulse generators and left sided extension were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1178930
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dennis100
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« Reply #38 on: January 14, 2014, 11:26:24 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Event Description
Journal reference: guehl d, vital a, cuny e, et al. Postmortem proof of effectiveness of zona incerta stimulation in parkinson disease. Neurology. 2008;70(16, pt. 2): 1489-1490. In this study, we report the first pathologically proven case of direct bilateral zi stimulation which dramatically improved the cardinal symptoms of pd in a pt implanted for severe pd 6 years previously and who suddenly died. A man was proposed deep brain stimulation (dbs) because he had severe pd for 13 years that had reached the stage of motor fluctuations with incapacitating levodopa-induced dyskinesia. He was operated on with proven effectiveness during 5 years of follow-up. Reportable event: six years after surgery, the pt was admitted to the hosp for generalized dyskinesia associated with lower leg dystonia, for which the daily dosage of l-dopa was slightly reduced from 700 to 500 mg/day. Thereafter, he exhibited severe incapacitating dystonia of the lower legs that was resistant to apomorphine. Two days later, his dystonia was more diffuse and affected the upper limbs and the trunk. The pt fell into a coma with malignant hyperthermia, suggesting the diagnosis of rhabdomyolysis related to severe incapacitating dystonia. Screening for bacterial infections was negative. The clinical picture was complicated by the occurrence of liver insufficiency and he died from hemorrhage after 2 wks of intensive resuscitation. Our histologic data showed that none of the contacts was located within the stn, probable because we were not able to perform peroperative electrophysiologic recordings to guide the targeting in this subject. The electrodes passed just above the stn and were located within the zi. Therefore, the dramatic improvement in rigidity, akinesia, and tremor appears to be closely associated with zi stimulation. (see scanned pages).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069224
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dennis100
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« Reply #39 on: January 14, 2014, 11:27:31 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: lohmann e, welter m-l, et al. Are parkin patients particularly suited for deep-brain stimulation mov disord. 2008; 23(5): 740-743. Patients with parkin mutations are known to have slower pd progression and a better response to levodopa at lower doses than patients with idiopathic parkinson's disease. To determine the effects of deep brain stimulation (dbs) on such patients, we have compared the follow-up after surgery of 7 patients with one parkin mutation, 7 patients with two parkin mutations, and 39 patients without parkin mutations. Twelve to 24 months after bilateral stn stimulation neurosurgery, the daily doses of levodopa equivalent were significantly lower in patients with two parkin mutations, indicating that these patients benefit from dbs, and they might have more durable results. Reportable event: one complication was noted at 12 month follow-up. One of the patients with two parkin mutations experienced a severe atypical ballistic dyskinesia in the legs after surgery, reminiscent of similar complications in some pd patients who underwent neural transplantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069549
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dennis100
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« Reply #40 on: January 14, 2014, 10:30:03 PM »

Model Number 7428
Device Problem Device remains implanted
Event Date 07/28/2008
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description
When inserting one of the electrodes, the surgeon grazed a blood vessel producing a slow blood leak. There was no indication that anything was wrong during the surgery. The manufacturer's field representative reported that the hemorrhage may be attributed to the right-sided lead and that the hemorrhage was below that, at the tip of the lead level. There were no blood pressure or heart rate spikes during surgery. Recordings and macrostimulation during surgery were good. It appeared the patient was going to have a great outcome. About 5 hours after the implantation of the deep brain stimulator leads, a blood clot the size of a baseball formed in the patient's brain. The patient was taken back to surgery and 89% of the clot was removed. A computerized tomography scan revealed that some of the blood had leaked into the third and fourth ventricles surrounding his brain stem. The patient was admitted to the intensive care unit. He was given supplemental oxygen. The patient was fed through a nasogastric tube initially. A permanent gastric tube was surgically placed later. The damage to the left side of the brain had partially paralyzed the left side of his body. Though unable to open his eyes or speak, the patient was able to acknowledge his family by squeezing his right hand. The patient's family believed his condition had improved during the week following surgery. The patient was moved out of the intensive care unit to a skilled nursing facility where he was given speech therapy, physical therapy and other skilled specialist. Approx 6 weeks after the surgery, the pt had lost 15 pounds. He had difficulty moving his left leg. He was able to swallow ice chips at that time. The pt was able to communicate nonverbally with his family and was able to form a few words. He slowly gained better use of his right hand. The pt was making progress using equipment in the nursing facility. Much of the info above was reported via a call. Add'l info has been requested. A follow-up report will be submitted if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1162669
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dennis100
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« Reply #41 on: January 14, 2014, 10:30:55 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Literature: biolsi b, cif l, fertit he, robles sg, coubes p. Long-term follow-up of huntington disease treated by bilateral deep brain stimulation of the internal globus pallidus. J neurosurg. 2008;109(1):130-132. Deep brain stimulation is now accepted as a safe and efficient treatment for movement disorders including selected types of dystonia and dyskinesia. Very little, however, is known about its effect on other movement disorders, particularly for "choreic" movements. Huntington disease is a fatal autosomal-dominant neurodegenerative disorder characterized by movement disorders, progressive cognitive impairment, and psychiatric symptoms. Bilateral chronic stimulation of the internal globus pallidus was performed to control choreic movements in a man with a 10-year history of huntington disease. Chronic deep brain stimulation resulted in remarkable improvement of choreic movements. Postoperative improvement was sustained after 4 years of follow-up with a marked improvement in daily quality of life. Reportable event: bradykinesia in the lower extremities was visible 2-3 weeks after dbs, which improved following treatment with levodopa (187. 5 mg). Four years after surgery the improvement of chorea remained stable. We observed a clear improvement in motor control when comparing stimulation-on and -off conditions at 4 years. Neuropsychological assessment again found a moderate subcortical cognitive dysfunction with no evolution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1163605
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dennis100
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« Reply #42 on: January 14, 2014, 10:31:43 PM »

Model Number 7428
Device Problem Device remains implanted
Event Date 07/28/2008
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description
When inserting one of the electrodes, the surgeon grazed a blood vessel producing a slow blood leak. There was no indication that anything was wrong during the surgery. The manufacturer's field representative reported that the hemorrhage may be attributed to the right-sided lead and that the hemorrhage was below that, at the tip of the lead level. There were no blood pressure or heart rate spikes during surgery. Recordings and macrostimulation during surgery were good. It appeared the patient was going to have a great outcome. About 5 hours after the implantation of the deep brain stimulator leads, a blood clot the size of a baseball formed in the patient's brain. The patient was taken back to surgery and 89% of the clot was removed. A computerized tomography scan revealed that some of the blood had leaked into the third and fourth ventricles surrounding his brain stem. The patient was admitted to the intensive care unit. He was given supplemental oxygen. The patient was fed through a nasogastric tube initially. A permanent gastric tube was surgically placed later. The damage to the left side of the brain had partially paralyzed the left side of his body. Though unable to open his eyes or speak, the patient was able to acknowledge his family by squeezing his right hand. The patient's family believed his condition had improved during the week following surgery. The patient was moved out of the intensive care unit to a skilled nursing facility where he was given speech therapy, physical therapy and other skilled specialist. Approx 6 weeks after the surgery, the pt had lost 15 pounds. He had difficulty moving his left leg. He was able to swallow ice chips at that time. The pt was able to communicate nonverbally with his family and was able to form a few words. He slowly gained better use of his right hand. The pt was making progress using equipment in the nursing facility. Much of the info above was reported via a call. Add'l info has been requested. A follow-up report will be submitted if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1162669
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dennis100
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« Reply #43 on: January 16, 2014, 12:42:16 AM »

Model Number 7428
Device Problem Pocket stimulation
Event Date 10/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a loss of therapeutic effect from their deep brain stimulator. The symptoms were noticed about ten days prior. There was no known incident related to the onset of the symptoms. The physician has had to increase the pt's medications. The pt was seen in the clinic. Movement did not cause changes in the stimulation but palpating the device did cause changes in the stimulation. Palpation of the device pocket and lead extension area caused a sensation down the arm and leg. Add'l info has been requested but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1257496
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dennis100
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« Reply #44 on: January 16, 2014, 06:40:14 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/01/2008
Event Type  Malfunction 
Event Description
The patient fell several times; the most recent fall was a month ago. Afterward, he experienced a 'deadening of the legs'. The deep brain stimulator was still working. No device troubleshooting was reported. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfr. Report# 30420917200807653.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1277789
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dennis100
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« Reply #45 on: January 16, 2014, 06:41:41 AM »

Model Number 7428
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 10/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported the patient was experiencing nervousness and shaking for the last 2 to 3 days. The left hand and leg seemed to be the most affected. The patient had experienced a fall approximately ten days prior. Since the fall, walking had gotten substantially worse. The patient had gone to the er (date unknown) and was given benadryl, which seemed to calm her nerves. The patient was at home at the time of the report. Additional information has been requested, but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1277784
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« Reply #46 on: January 17, 2014, 12:53:50 PM »

Model Number 7426
Device Problems High impedance; Device remains activated; Inappropriate shock
Event Date 01/19/2006
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced uncomfortable shocking sensation in his jaw and down the side of his face, arm, or leg (it was unclear which body side). The impedances of electrode 0 on right lead was greater than 2000 ohms; the current was 11 microamperes, suggesting an open circuit. The impedance on electrode 0 of the left lead was also greater than 2000 ohms; the current was 7 microamperes, suggesting an open circuit. The hcp palpated all of the implanted components but was not able to reproduce any shocking sensation to the patient. X rays were performed and did not reveal any obvious wire fractures or disruptions. The right-sided deep brain stimulator had a battery voltage of 3. 6 volts and was replaced. The extension was replaced at the same surgery. Additional surgery was being considered if the shocking continued. Please see mfr. Report # 3004209178200900214.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287236
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« Reply #47 on: January 17, 2014, 12:54:43 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 01/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient had difficulty walking, leg weakness and paresthesias. The patient complained that after her most recent programming session her speech became like a whispering and she had fallen nine times. The patient was directed to contact to physician for a reprogramming consultation. Additional information has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer report # 3004209178200900227.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287241
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« Reply #48 on: January 17, 2014, 09:12:37 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 10/23/2008
Event Type  Injury   Patient Outcome  Disability
Event Description
It was reported that the pt experienced no therapeutic effect and a change in gait with difficulty walking and leg weakness two days after lead implant. It was unk if the pt's symptoms were related to the implant or spinal stenosis. Additional testing was pending. Additional info has been requested, but was not available as of the date of this report. Reference mfr. Report # 3004209178200901277.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325823
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« Reply #49 on: January 17, 2014, 09:13:50 PM »

Model Number 7426
Device Problems Other (for use when an appropriate device code cannot be identified); Implant, reprogramming of
Event Date 02/11/2009
Event Type  Malfunction 
Manufacturer Narrative
For return to default settings.

 
Event Description
The patient started having dystonia symptoms starting 2 days post implant in his legs and feet. The deep brain stimulator was reprogrammed frequently. The hcp had taken the patient on and off his parkinson's disease medications several times. The patient experienced symptom relief but had dyskinesia at an amplitude of 2. 5 volts. When the amplitude was lowered to 2. 1 volts and the patient felt some dyskinesia but also had a return of symptoms. The field representative reported that while doing a normal impedance check, the voltage changed from 2. 1 volts to 1. 5 volts. The pulse width and rate returned to default settings (210 microseconds, 30 hertz). Patient symptoms associated with the event included left-sided dystonia, dyskinesia, difficulty breathing, talking, and a voice change. The patient kept the deep brain stimulator turned off due to the dystonia symptoms. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfg report # 3004209178-2009-01700.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386201
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« Reply #50 on: January 17, 2014, 09:14:28 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported, the patient experienced a shocking or jolting sensation after turning the device back on after an ekg. The patient didn't appear to have a "soft start" and used a magnet. The patient also felt a "tremor" in his leg when he was driving, but no longer had tremors.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1333324
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« Reply #51 on: January 17, 2014, 11:02:08 PM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Date 02/22/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The patient experienced a loss of therapeutic effect. There were no falls of incidents related to the event. Impedances were checked and some of the electrodes were found to be >2000 ohms. Reprogramming was done which gave the patient some benefit, but then the patient was getting a tingling sensation down her leg. Further troubleshooting was being considered. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387857
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« Reply #52 on: January 18, 2014, 04:32:26 AM »

Model Number 7428
Device Problems Extraneous radiofrequency wave transmission; Replace; Inappropriate shock; Implant, reprogramming of
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced worsened tremor. The deep brain stimulator was replaced due to battery depletion. At the clinic visit 1 week after device replacement, the pt experienced improved gait and slightly improved tremor control. The pulse width was increased resulting in complete tremor control to the left side of body. Mild to moderate tremor persisted in the right upper limb and occasionally right leg. The patient experienced right shoulder pain. The patient was treated with ropinirole xl and sinemet. At a clinic visit approximately 1 month later, the patient felt shocking when the device was turned on at an amplitude of 4. 0 volts. Impedances were greater than 4000 ohms on electrode combinations involving electrode #3. The tremor was well controlled at 4. 8 volts, but the patient had deteriorated, slurred speech. Therapy amplitude of 5. 7 volts controlled tremor, but caused right-sided tingling and increased slurring of speech. The pt experienced slight right-sided tingling at 4. 7 volts. At 5. 2 volts, the patient felt slight numbness to the left leg. The ropinirole caused facial dyskinesias. The device was reprogrammed to previous settings (as they were prior to generator replacement). The patient had better tremor control on the right body side on lower settings. The patient's postural stability was similar to that before increasing the settings. The patient's speech was less slurred, but slow at times. The patient ambulated with slow, small steps. The patient's condition was not able to be stabilized with reprogramming. The deep brain stimulator was replaced (b)(6) 2009. The patient was doing well with the new stimulator at the original settings. The nurse mentioned that there was.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370871
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dennis100
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« Reply #53 on: January 18, 2014, 04:33:41 AM »

Model Number 7426
Device Problems Repair; Implant, reprogramming of
Event Date 09/25/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient underwent a lead revision due to stimulation in the wrong location. The patient had also undergone a previous revision in 2008. The patient was still experiencing stimulation in the wrong location and a third revision was planned. The patient's stimulation had been felt in the legs and stomach area for about 2 years. Several device programming attempts were made but had not helped. Reference mfr report #3004209178200902683 for lead revision from 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1367853
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dennis100
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« Reply #54 on: January 18, 2014, 04:35:50 AM »

Model Number 7426
Device Problem Loss of power
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a loss of therapeutic effect. The patient stated they were more forgetful, could not walk very well, and that balance was bad. The patient experienced double vision and reported feeling like they were in a bubble. The patient reported that the implantable neurostimulator battery was at 35% and they were having "major problems". The patient also reported problem with the patient programmer. The patient noted that the implantable neurostimulator (ins) was turning on and off without warning. The patient stated they went to the er and the implantable neurostimulator was turned back on there, then it turned off again when the pt went home. The patient's physician informed the patient that their ins had been off for two weeks but the patient stated that the patient programmer never indicated this. Additional information has been 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=1458868
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dennis100
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« Reply #55 on: January 18, 2014, 02:22:18 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease; five year follow-up. J neurol. 2009; 256(2): 225-233. Summary: this study assessed the long-term efficacy and safety or bilateral subthalamic nucleus (stn) stimulation in patients with advanced parkinson's disease (pd). A total consecutive patients with idiopathic pd treated with bilateral stn stimulation were enrolled from 1998 to 2002. It was reported that one pt experienced lower limb phlebitis immediately postoperatively complicated by a pulmonary embolism. See manufacturer report number: 2182207200903228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378215
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dennis100
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« Reply #56 on: January 19, 2014, 11:01:35 PM »

Model Number 7426
Device Problems Replace; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Other
Event Description
The pt felt stimulation in his legs and stomach for 2 years. Reprogramming was unsuccessful in resolving the issue. The hcp reported that the pt was having persistent problems with dystonia starting in the right leg and working up to the entire abdomen causing significant pain. The pt underwent revision surgery, changing the target to the globus pallidus interna. After programming the pt reported much relief and resolved dystonia. The pt was still being followed due to fluctuating symptoms. The pt outcome was reported as 'no injury. ' it was unknown if the event could be attributed to the implantable device systems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1420880
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dennis100
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« Reply #57 on: January 19, 2014, 11:03:13 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/17/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The day prior the pt started to experience drooling, a sensation of his tongue being stuck, and tingling in his left leg. It was noted that at some point, the pt had been wrestling around with friends. X-rays were taken and no problem was detected. The device settings at the time were c+, 1-, 2-, 3-, 2. 9v, 90 pw, 185hz. The pt had not yet been evaluated by the healthcare provider. The outcome is unk. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1465678
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dennis100
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« Reply #58 on: January 20, 2014, 02:20:35 AM »

Model Number 7426
Device Problems Device operates differently than expected; Electromagnetic compatibility issue
Event Date 10/19/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The pt's 2 deep brain stimulators were turned off prior to surgery. Afterward surgery, the pt's legs were freezing up. The pt was seen by their hcp, who found that one of the deep brain stimulators was turned off. It was believed to have been turned back on after surgery. Several days later, the contra lateral device was found to be off. It was believed that the device turned off on its own. The stimulator may have been affected by a microwave. Additional info has been requested. A f/u report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566642
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dennis100
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« Reply #59 on: January 20, 2014, 12:48:39 PM »

Model Number 7426
Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient's implantable neurostimulator system was alleviating the patients shaking, but caused speech issues and "too much flexibility" in the patient's legs. It was reported that patient had fallen numerous times and had recently fallen and broken her shoulder. Additional info has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer's report 3004209178-2009-04223.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1404951
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