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Author Topic: Deep brain stimulator - Arms  (Read 52319 times)
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dennis100
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« Reply #30 on: January 09, 2014, 04:35:52 PM »

Model Number 7428
Device Problems Device remains implanted; Inappropriate shock
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt experienced a fall or some other form of trauma. Since that time, he had a loss of therapeutic effect; the tremor in his left arm was returning and his speech was getting worse. The pt also experienced shocking/jolting sensation. Additional info has been requested from the hcp, a follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064799
« Last Edit: January 17, 2014, 10:24:28 PM by dennis100 » Logged
dennis100
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« Reply #31 on: January 09, 2014, 04:36:21 PM »

Model Number 7428
Device Problems Device remains implanted; Inappropriate shock
Event Date 03/27/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Following battery replacement, the pt experienced a shocking/jolting sensation in his left arm. Following battery replacement and a fall or some other form of trauma ( date not reported), the pt experienced a loss of therapeutic effect, loss of balance, and dyskinesia. The pt was at home and was encouraged to contact his hcp. Additional info has been requested from the hcp, a follow-up report will be sent if additional info becomes available.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064784
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dennis100
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« Reply #32 on: January 09, 2014, 04:37:41 PM »

Model Number 7428
Device Problem Replace
Event Date 10/31/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt underwent removal of the bilateral gpi dbs leads and implantation of stn placed leads. The pt had the dbs sys placed in 2005. The pt did not receive benefit. The pt became progressively more disabled despite implantation of dbs. The pt was evaluated prior to the revision. The pt's only new complaint was that he noted some difficulty urinating while standing although he felt he was able to fully empty his bladder while in a sitting position. He had no dysuria or other urinary tract complaints. The pt had been started on lasix 20 mg/day for peripheral edema in 2008. It had been somewhat effective in improving the edema in his hands and ankles. The pt had no shortness of breath, chest pain, or other cardiopulmonary complaints. The pt was admitted to the hosp in 2006. The pt's physical exam revealed blood pressure 112/64, heart rate 76, respirations 16, pt's weight which was decreased by two pounds since the month before. Exam was otherwise unchanged from previous exams. It was notable for an irregular cardiac rhythm, dyskinesias of the arms and legs, slow shuffling gait, and abnormal posture with the upper body held in a forward, flexed, position. There was trace to 1+ pedal edema noted. The leads were replaced. The new leads were connected to the previously implanted extensions and the generators were tested. The impedances were found to be normal. The procedure was well tolerated. The pt was discharged on two days later. Prognosis for improvement of pd motor symptoms was good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1066633
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dennis100
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« Reply #33 on: January 09, 2014, 04:39:24 PM »

Model Number 7426
Device Problems Loss of power; Program, failure to
Event Date 04/02/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt woke up feeling fine. Forty five minutes later, the pt knew something was 'not quite right'. He started having more left-sided tremor and fell backwards, but was caught by a family member before he fell. It was also reported that the pt was unable to feel stimulation after a fall down the steps or some other trauma. The pt was unable to adjust stimulation. The pt was seen by his primary hcp the day of the incident. He had a neurology consultation approx 7 days after the original incident. There he had a pronounced increase in left arm tremor. It was harder for him to walk and he had been dragging his left leg more. Voice quality was originally alright, but later the pt noticed that he was stuttering more. He was having some drooling, greater on the right side. Facies were somewhat flat, although he could smile and laugh during the exam. He had micrographia. His last deep brain stimulator programming was four months prior to the exam. Physical exam also revealed left arm rigidity. He had +3 left arm rigidity and a 2-3 tremor, although at times it did quiet down. He had +1 increased tone and rigidity of his right hand. He was unable to do finger taps at all with his left hand and was able to do taps with his right, although he did demonstrate some bradykinesia. Hand pronation and supination again demonstrated bradykinesia bilaterally, left greater than right. He had strong hand grasp bilaterally. He did not drift with eyes closed and arms extended. He had a fine tremor, left greater than right when his arms were extended at rest. He had bilaterally increased tone and rigidity of the lower extremities. He was +2 on his right leg and +4 on his left. There was no tremor of his lower extremities at exam. Foot taps demonstrated decreased amplitude in his right more than left; both demonstrated bradykinesia. He arose independently from a chair using both arms to push up with multiple attempts. While up walking with his walker, he had some bradykinesia, but was able to pick up both of his feet and did not demonstrate any real shuffling at exam. He took a slow turn. No interrogation was possible with the device stimulating his right brain/left side of his body. Left brain neurostimulator settings and impedances were within normal limits. The hcp increased the stalevo 50 mg from 4 to 5 times a day. The pt and his wife were instructed how to increase his medications if needed to control his oral symptoms. The device had been or will be replaced.

 
Manufacturer Narrative
The report was submitted late by the mfr's rep, retraining has been conducted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1068140
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dennis100
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« Reply #34 on: January 13, 2014, 01:28:18 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 #35 on: January 13, 2014, 01:32:15 AM »

Model Number 7495-66
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 03/19/2008
Event Type  Malfunction   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt began experiencing a loss of therapeutic tremor control on one side. The symptoms began shortly after the pt's left ipg was replaced. The pt reported receiving a shock down his arm and into his hand while taking a picture. Attempts to interrogate the pt's ipg were unsuccessful with the clinic programmer. The pt's programmer was tried and also resulted in a telemetry error. An attempt to interrogate the pt's other ipg (right side) was successful; however, ruling out a programmer error. The pt has very mild tremor on the right side, so it can be hard to tell if the pt is getting therapy from the left device, but it appeared the pt had more pronounced tremor. An x-ray was taken, but no results were reported. Based on the x-ray, the hcp scheduled the pt for surgery. The plan was to disconnect the extension, clean the area and reconnect the wire as well as open the ipg pocket and check the device for orientation. Follow up info indicated the left ipg pocket was opened and the battery checked. The device was not inverted, but was implanted deeper than the typical 1/2 inch (1-1. 5 inches). The ipg was interrogated and the battery was found to be fully charged; therefore, ruling out a depleted battery or short circuit. The same battery was placed superficial to the original pocket. Interrogation revealed normal impedance values and device settings. The extension pocket was then opened at the lead extension junction. The boot was removed form the extension, the contacts cleaned, extension head suctioned, and re-assembled with a new boot. The right ipg was changed out at this time as well and programmed to the last known settings. In recovery the devices were interrogated, found to be normal, and were programmed. The pt remained groppy and did not have his programmer, so the devices were left off until later time. The right battery was programmed for a slightly lower voltage to compensate for a fresh battery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025678
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dennis100
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« Reply #36 on: January 13, 2014, 03:16:44 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: hyam; post-deep brain stimulation - gradual non-stimulation dependent decrease in strength with attenuation of multiple sclerosis tremor 2007/254/7/854-60. We describe five patients with multiple sclerosis in whom upper limb tremor severity gradually decreased over a period of several years after deep brain stimulation. In every case this attenuation of tremor was accompanied by increasing pyramidal weakness in the relevant upper limb. In two patients this attenuation of tremor remained after stimulation was permanently switched off. In one other patient, where upper limb strength remained normal, tremor severity gradually worsened in spite of continuing stimulation. The manufacturer was not identified.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026791
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dennis100
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« Reply #37 on: January 13, 2014, 03:17:24 AM »

Model Number 3387
Device Problems Device remains implanted; Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that the patient had suffered several falls, subsequent to dbs system placement. The patient had swelling between the shoulder and elbow at the area of paresthesia in the patient's upper right arm. A tingling sensation had been detected in the right arm, which became worse with increased movement. The patient visited her physician (date of follow-up was not provided). The device was not reprogrammed and surgery was not anticipated. The patient indicated that product issues were on-going. She also reported she had experienced light shocks that happened infrequently and were attributed to the implanted system. The patient's status was reported as fair. Additional information has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026786
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dennis100
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« Reply #38 on: January 13, 2014, 08:59:06 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 #39 on: January 13, 2014, 11:19:14 AM »

Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
 
Event Description
Samii a. "spinal accessory neuropathy after deep brain stimulation for parkinson's disease. " stereotactic and functional neurosurgery 2007, 85(6):296-298. It was reported that the pt underwent staged bilateral subthalamic nucleus deep brain stimulation electrode implantation of a medtronic deep brain stimulation system; the first electrode (model number unk), was implanted in the right subthalamic nucleus. Bleeding occurred from a superficial neck vein just above the right clavical when the tunneler passing device was removed. The bleeding was controlled when the extension was removed and pressure applied. A new subcutaneous tract was created and the extension was implanted. Postoperatively, the pt had right shoulder pain, ecchymosis lateral to the implantable pulse generator, and difficulty raising his right arm (weakness). He was subsequently diagnosed with right spinal accessory nerve injury (palsy), that had been confirmed by neuromuscular electrodiagnostic studies (electromyography and nerve conduction), possibly caused by a stretch injury to the nerve when the subcutaneous tunnel was created for placement of the extension device. Nerve conduction studies conducted six weeks after implant had revealed markedly reduced amplitude of the compound muscle action potential (cmap), from the right trapezius (0. 6mv), compared to the left trapezius (7. 4mv), with similar distal latencies. Needle electromyography had depicted positive sharp waves and fibrillation potentials and acute denervation in the upper, middle, and lower right trapezius was suspected. One month after the procedure, the pt had 2/5 strength in his right shoulder elevation/abduction and atrophy of the right upper trapezius. Six weeks after the procedure, findings from nerve conduction and electromyography studies had suggested a poor prognosis. The pt had electrode implantation in the left subthalamic nucleus 8 months after the first surgery, without complication. Nine months after the procedure, the pt had significantly improved pain, minimal atrophy of the right upper trapezius, and nearly symmetric shoulder strength. Within 1 yr and after extensive rehabilitation during recovery, the pain, shoulder weakness, and trapezius muscle atrophy had nearly completely resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014500
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dennis100
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« Reply #40 on: January 14, 2014, 12:24:07 PM »

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 #41 on: January 14, 2014, 12:25:26 PM »

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
« Last Edit: February 03, 2014, 01:32:02 AM by dennis100 » Logged
dennis100
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« Reply #42 on: January 14, 2014, 12:26:16 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/20/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the pt experienced a burning sensation in the tongue and forearms. The pt "turned down the system" and the symptoms were reduced. The symptoms returned the following day. The pt also had attempted to turn the device off with his programmer with no improvement. Add'l info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077018
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dennis100
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« Reply #43 on: January 14, 2014, 12:26:43 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/11/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a loss of therapeutic effect and intermittent tingling in the lips and down the arm. The health professional told the patient they could not find "anything wrong with the device". No outcome was reported. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1078572
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dennis100
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« Reply #44 on: January 14, 2014, 08:22:51 PM »

Model Number 7426
Device Problems Inappropriate shock; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2008
Event Type  Injury 
Event Description
When the deep brain stimulator was on, the patient experienced a jolting sensation in his left arm. The patient had used a magnet the size of a license plate to pick up other magnets. The patient was in the clinic at the time of the report. The hcp reported the patient status as 'undetermined'. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216586
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« Reply #45 on: January 14, 2014, 10:12:32 PM »

Model Number 7428
Device Problems Device remains activated; Inappropriate shock
Event Date 08/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt experienced a quick, minor shock in his arm and hand when therapy was turned on. The deep brain stimulator was in 'soft start' mode. The amplitude had been increased from 0. 5 volts to 1. 9 volts at the last clinic visit. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1176145
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« Reply #46 on: January 14, 2014, 10:12:59 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 09/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient was experiencing pain in his arms at extremely low voltage settings on his dbs device. The patient used to get good therapy at 3 volts. Now, the patient can not tolerate the device being set at 0. 1 volts. It was unknown if the patient had recently suffered a fall or trauma. Impedance measurements had not been performed. Troubleshooting was being considered. 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=1193446
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« Reply #47 on: January 14, 2014, 10:14:12 PM »

Model Number 7424
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: schuurman pr, bosch da, merkus mp, speelman ld. Long-term follow-up of thalamic stimulation versus thalamotomy for tremor suppression. Mov disord, 2008;23(8 );1146-1153. Thalamic stimulation and thalamotomy for treatment of tremor due to parkinson's disease, essential tremor, and multiple sclerosis were compared in a randomized trial. The symptomatic and functional outcome was studied after 5 years of follow-up. Sixty-eight patients were treated (45 pd, 13 et, 10 ms) by thalamotomy (n = 34) or thalamic stimulation (n = 34). After 5 years, 48 patients were available for follow-up. Reportable event: three stimulation patients experienced arm ataxia. See mfg report 2182207-2008-05826.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1162683
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« Reply #48 on: January 14, 2014, 11:38:19 PM »

Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: bailine s, kremen n, kohen i, et al. Bitemporal electroconvulsive therapy for depression in a parkinson disease pt with deep-brain stimulator. J ect 2008;24(2):171-172. We report the successful treatment of an episode of major depression with psychotic features with electroconvulsive therapy (ect) in a woman with advanced parkinson's disease who had a left subthalamic nucleus deep-brain stimulator (dbs) in place. Electroconvulsive therapy effectively and safely treated the pt's depression without harming the pt or damaging the dbs hardware. We offer additional evidence about the safety and efficacy of electroconvulsive therapy in pts with dbs. Reportable event: after the dbs procedure, she had some improvement in her dyskinesias on the side contralateral to stimulation but continued to experience motor fluctuations, depression and anxiety. She also complained of poor sleep, panic attacks, sob, chest pain, and shaking. She attempted suicide and was admitted to the hospital. On admission, she had bilateral upper extremity dyskinesia and was paranoid. After informed consent for ect was obtained, she received 7 treatments for 3 weeks. A bitemporal electrode placement was chosen to maximize the distance between the dbs electrode, and the ect electrodes. Before the first ect treatment, the dbs currents were turned off, with the voltage set to 0. They remained off for the duration of her hospital stay and were not turned back on. There was no worsening of her parkinsonian symptoms during the acute ect course. She was discharged with psychotropic medications. Post-ect computerized tomography scan revealed no shift in dbs electrode position.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161209
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« Reply #49 on: January 16, 2014, 12:15:15 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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« Reply #50 on: January 16, 2014, 12:16:34 AM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced a shocking or jolting sensation down her arm when she reached for something. There was no known incident or accident related to the complaint. The patient had a few falls 'quite some time' before the shocking symptoms appeared. The patient status was reported as 'fair' at the time of the complaint. The patient was seen twice by her hcp since the initial complaint; details of the visits were not available at the time of this report. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfr. Report # 3004209178-2008-05453.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1150401
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dennis100
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« Reply #51 on: January 16, 2014, 12:17:35 AM »


Model Number 7426
Device Problems High impedance; Inappropriate shock
Event Date 08/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt fell and a week later experienced a tingling stimulation sensation down the entire right side of her body. The tingling wasn't painful. The sensation occurred 30-40 times in one weekend. The pt also experienced a shocking sensation down her right arm. The pt initially had good therapeutic effects, unaffected by the tingling. Three weeks later it was reported that therapy efficacy was questionable. The hcp was able to replicate the tingling sensation by palpating behind the pt's ear at the lead/extension connection. X-rays were negative. Impedances were greater than 2000 ohms and current was less than 7 microamperes in all possible bipolar electrode and electrode-case combinations of the left deep brain stimulator. The hcp planned to do surgery. Additional info has been requested. A follow-up report will be submitted if additional info becomes available. Please see mfr. Report # 3004209178200805657.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159115
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dennis100
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« Reply #52 on: January 17, 2014, 08:13:34 AM »

Model Number 7426
Device Problems Pocket stimulation; Implant, reprogramming of
Event Date 12/01/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
The patient had a deep brain stimulator for tremor due to unknown cause (not parkinsons or essential tremor). In late 2008, the patient experienced a loss of efficacy. Symptoms included extreme cramping and tightness in his arm. Two weeks later, the patient experienced a 'stroke-like' episode where he could not speak or move. The patient was hospitalized. Test results did not show a stroke or seizure. The patient regained speech and movement 3 days later. The device was interrogated and reprogrammed. The system was fine, but reprogramming did not improve tremor control. The patient also recently experienced a ;'pinching' sensation in the pocket. The patient was in contact with his hcp. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1299103
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dennis100
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« Reply #53 on: January 17, 2014, 12:27:26 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 #54 on: January 17, 2014, 12:28:52 PM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Date 05/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that beginning in 2007, the pt experienced a range of "surges" from "mild to one that goes though me that makes me lurch/jump a little bit". The shocking was "not so bad" but as the pt began to keep track, he noticed the shocking/jolting "happening a dozen times a day". The pt had periodic shocks and feelings of electricity in the chest and down the left arm 'emanating from a wire". When the pt used the programmer to check the battery, he "felt a surge of electricity go through me". After experiencing a powerful jolt, the pt feels lightheaded for 10-20 seconds. The pt reported an increase in tremors in the right hand and shaking worse than prior to the implant. The pt stated he had, "reasonable handwriting and now barely able to sign my own name - big scribble". The pt had an appointment with the hcp, although the hcp felt there was no issue with the shocking and, the tremors were a progression of the disease. The pt additionally reported falling and fracturing his right hip, but did not feel it was due to the device, as he was having issues prior to the fall. Impedance readings were done with all monopolar readings within normal limits. Bipolar readings between 0 and 3 were >2000 ohms. X-rays showed no sign of a lead fracture. The battery was found to be at 3. 57 volts. The device was reprogrammed around the 0 contact. The pt had changed his hcp and was scheduled to replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1286581
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« Reply #55 on: January 17, 2014, 01:16:22 PM »

Model Number UNKNOWN
Device Problems Inappropriate shock; Other (for use when an appropriate device code cannot be identified)
Event Date 10/16/2008
Event Type  Death   Patient Outcome  Death
Event Description
It was reported that the day after the neurostimulator was replaced due to low battery the patient experienced a metallic taste in his mouth and tingling in his head, and bilateral upper extremities (left greater than right). The patient also experienced pain. Touching the neurostimulator elicited shocks. The sensations were experienced even when the voltage was turned to zero. An x-ray (2008) was performed. No evidence of discontinuity was noted. A mri (2 days later) noted the leads were in the subthalamic region. The patient outcome was noted as a non-serious injury/illness and death. No date of cause of death was reported. The relationship of the patient's death to the device/therapy or the events reported was not reported. 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=1328112
« Last Edit: February 03, 2014, 01:32:30 AM by dennis100 » Logged
dennis100
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« Reply #56 on: January 17, 2014, 07:20:02 PM »

Model Number 7426
Device Problems Replace; Inappropriate shock; Unit inactivated
Event Date 01/07/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt experienced a shocking sensation while the stimulator was turned on. The surge of stimulation was felt when the hcp pressed the telemetry head of the physician programmer over the ins site. No telemetry had been done when this occurred. The pt denied any recent falls or trauma. The surge went down the pt's arm and the side of the body. No other incidents or changes in stimulation were noted prior to, or since, the event. The pt was seen in the clinic and was in good condition. Additional information received indicated the hcp sent the pt for an x-ray to rule out any fractures in the lead or extension. The x-ray did not show any fractures. Impedances were done and showed no abnormalities. The pt's device was turned off pending further investigation. A battery change was scheduled for 2009. The extension was also replaced. The pt has bilateral systems. The manufacture's device tracking system indicated it was the left side ins and extension which were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1304662
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« Reply #57 on: January 17, 2014, 10:25:18 PM »

Model Number 7428
Device Problem Electro-magnetic interference (EMI)
Event Type  Malfunction 
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
It was reported the patient experienced a loss of therapeutic effect following exposure to ultrasonic treatment at the dentist. The symptoms were at the neck and arms. The patient was at home and the status was reportedly good. The indication lights were reviewed with the patient and it was determined the stim was turned off. The manufacturer technical agent had the patient turn their stim on and reviewed patient on / off options until the stimulator could be checked by the physician or manufacturer representative.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354652
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dennis100
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« Reply #58 on: January 17, 2014, 10:25:48 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Malfunction 
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
The patient reporte feeling a surge of electricity down his arm. The stimulator was turning on and off intermittently. The manufacturer representative referred the patient to his physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354654
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dennis100
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« Reply #59 on: January 17, 2014, 10:27:00 PM »

Model Number 7428
Device Problem Replace
Event Date 02/03/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the stimulator was replaced due to pt reports of change in speech, contraction of right arm and hand, tingling and drawing of the right side of the face and mouth when head turned toward right. When the system is on, a shocking sensation is felt at first then it levels off the symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325826
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