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Author Topic: Deep brain stimulator - Hand  (Read 24117 times)
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dennis100
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« on: January 14, 2014, 08:35:25 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 09/20/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The pt experienced a shocking sensation in the morning for 2 hours. Then between 1 pm and 3 pm, it got worse; she was feeling the shocks every 10 seconds. The shocks were felt in the face, tongue, and right hand. The pt went to the emergency room and the stimulator was turned off. The pt had an appointment scheduled with her neurologist. Additional info has been requested, 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=1208444
« Last Edit: July 15, 2015, 11:49:18 PM by dennis100 » Logged
dennis100
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« Reply #1 on: January 14, 2014, 09:45:42 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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dennis100
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« Reply #2 on: January 14, 2014, 09:46:19 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 09/03/2008
Event Type  Malfunction 
Event Description
The patient experienced a loss of therapeutic effect; a tremor had returned to her right hand. She felt a jolting sensation when the hcp attempted to interrogate her deep brain stimulator. There was no known incident or accident related to the complaint. The integrity of the circuit appeared normal. Palpation of the lead extension area did not replicate the jolting sensation. All bipolar and case-electrode impedance measurements were within normal limits. The device was programmed to 0-, 1+ with a impedance of 1451 ohms and a current of 31 microamperes. The hcp planned to get x-rays to determine if any connections were loose. 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=1191178
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dennis100
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« Reply #3 on: January 16, 2014, 01:32:35 AM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 08/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The pt fell 60 feet down a hill. He had both a deep brain stimulator and spinal cord stimulator implanted. Please see mfr. Report# 3004209178-2008-05664. Afterwards, when the stimulation was turned on, the pt's left hand became numb, he experienced pain in the area of paresthesia of his back, and he experienced pain in his chest 'like he was having a heart attack'. The pt experienced shocking or jolting sensation in his area of paresthesia following the fall. The shocking occurred when the pt moved his head up and back, thus limiting his positioning. The patient felt pain when he touched the back of his neck. There was a knot the size of a dime on the back of his neck. The patient had migraines when the device was off. The pt couldn't tolerate the pain when he turned neurostimulator off. The pt was in contact with his hcp. Additional info has been requested. 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=1260053
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dennis100
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« Reply #4 on: January 16, 2014, 06:26:15 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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dennis100
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« Reply #5 on: January 17, 2014, 12:44:15 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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dennis100
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« Reply #6 on: January 17, 2014, 01:22:35 PM »

Model Number 7426
Device Problems Replace; Inappropriate shock
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The device had been working appropriately; the pt had no difficulties turning off the device at night. The pt reported spontaneous turn-off of the device; on one occasion it cause him to slump out of his chair, he hit the back of his head and got briefly dazed. When the pt turned the device back on, he felt an abrupt "jolt" with exaggerated head tremors and hand tremors that settled down gradually over 45 minutes instead of the usual 3 to 5 minutes. Treatment was initiated for possible epilepsy with no change in symptoms, so treatment was discontinued. At physical exam left tenderness over nape of neck, connectors from burrhole to ipg intact, intentional action tremor. Ipg reads -2+1, amp 3. 1 pw 90 rate 185, 45% usage time, multiple activations, impedance 1016, ampl 5. 6, 45% usage time. Battery voltage 3. 75. The pt was admitted to the hosp for observation; for device malfunction and sudden stimulation surges, causing confusion/presyncope and resultant concussion. Two days later, the device was replaced. It was reported he recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1328006
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dennis100
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« Reply #7 on: January 17, 2014, 07:28:22 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The patient fell 2-3 weeks ago and broke his left shoulder. The patient was taken in for an x-ray and the devices were turned off. When they turned the device back on, on the left side, the patient's right side of his mouth drooped and his right hand started to shake. The patient was in a nursing home. They were encouraged to contact the patient's physician. 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=1371376
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dennis100
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« Reply #8 on: January 17, 2014, 09:17:43 PM »

Model Number 7426
Device Problems High impedance; Device remains implanted
Event Date 02/20/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that there was impedance reading greater than 2000ohms on some of the unipolar pairs. Using 1 and 2 was sound, but caused tingling in the right pointer finger when stimulation was on. All other bipolar pairs were open except 1 and 2. The pt had noticed tingling in her finger the last 6-8 weeks. The last programming session was in 2008. Additional info received reported that the cause of the pt's symptoms was unk. The pt had new pain or hand paresthesias. An x-ray was performed (2009) with ap skull view which showed the stimulation system was intact. There were no findings. The pt outcome was reported as a non-serious injury/illness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1415415
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dennis100
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« Reply #9 on: January 17, 2014, 09:18:41 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 02/01/2009
Event Type  Injury 
Event Description
The pt was shutting the back window of her car when she received a shock that traveled from her right hand, down her arm, across her chest, to her left arm. The pt was seen by her hcp. Impedances were normal. There was no power on reset. Therapeutic results were fine. Please see mfr. Report# 3004209178200901805. Additional info has been requested. 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=1344064
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dennis100
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« Reply #10 on: January 17, 2014, 09:19:45 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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dennis100
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« Reply #11 on: January 17, 2014, 09:20:20 PM »

Model Number 7424
Device Problem Loss of power
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the pt had an accident and was assaulted and was hit in the head with a broom. Since then, he had been unable to turn on his device and experienced intermittent right hand tremor. A rough longevity calculation was estimated and suspected the device is near end of life.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325841
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dennis100
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« Reply #12 on: January 17, 2014, 09:21:50 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: strecker k, meixensberger j, schwarz j, winkler d. Increase of frequency in deep brain stimulation relieves apraxia of eyelid opening in patient's with parkinson's disease: case report. Neurosurgery. 2008;63(6) e1204. A male diagnosed with idiopathic parkinson's disease, since the age of 48 years suffered from micrographia and general slowing of motion. Due to motor fluctuations, drug-induced hallucinations, and severe gait disturbance, the patient underwent implantation of a deep brain stimulator of the subthalamic nucleus in 2000 with a routine exchange 2003. The patient was seen at the clinic in 2004, admitted for recurred gait disturbance and freezing. He also had hypokinesia, moderate rigidity (more on left side), hypomimia, severe dysarthria including hypophonia. Device settings were adjusted with marked improvement of hypokinesia and rigidity and speech. Gait disturbance showed some response, but occasional starting hesitation still occurred. Although, the positive effect on speech was transitory, improvement of hypokinesia and rigidity persisted. Over the next year, the patient developed apraxia of eyelid opening (aeo) that gradually worsened. Attempts to reduce the amplitude caused a worsened hypokinesia and gait disturbance. However, an increase of the stimulation frequency to 180 hz resulted in a prompt and persistent relief of aeo. Paresthesia in both hands was noticed after the adjustment of frequency, but it resolved within minutes. Dysarthria was also partially ameliorated. To test whether this would persist with lower frequencies, we set the frequency to 160 hz. The patient was still able to open his eyes, but only with considerable effort. When the frequency was changed back to 180 hz, this symptom resolved.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324326
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dennis100
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« Reply #13 on: January 18, 2014, 02:18:16 PM »

Model Number 7426
Device Problem Replace
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient experienced a loss of therapeutic effect with return of symptoms (tremor of the right hand and arm). The patient was unable to adjust stimulation with their patient programmer or with one sent by loaner/repair. Patient commented on end of life of their implantable neurostimulator. Additional information received reported that the patient underwent a surgical revision of their implantable neurostimulator and was no longer experiencing stimulation problems.

 
Manufacturer Narrative
The patient programmer was returned for analysis/repair. The device tested according to specifications. There was no anomaly found. The implantable neurostimulator was not returned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387040

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dennis100
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« Reply #14 on: January 19, 2014, 04:51:10 PM »

Model Number 7426
Device Problem Loss of power
Event Date 06/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the pt experienced a lack of therapeutic effect. The pt experienced tremors in their hands and "did not feel right". The pt programmer indicated that the pt's devices were no longer on. The pt was unable to turn devices back on. After repositioning the antenna, the pt was able to turn both devices back on. Refer to mfr report# 3004209178-2009-05190.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1489320
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« Reply #15 on: January 19, 2014, 04:55:01 PM »

Model Number 7428
Device Problems Fracture; Kinked
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a loss of therapeutic effect with a gradual increase in tremor on the right side, as well as intermittent shock-like sensations in the right hand and face with neck movement. High impedances were noted (2009) for all monopolar contacts on the left stimulation. The amplitude was lowered and an x-ray ordered. An x-ray (same day) revealed focal narrowing in the high cervical segment of the lead suggestive of a kink or break. The patient was referred to the neurosurgeon for further evaluation. A ct scan was performed (the following month) for surgical planning purposes, and then another post lead placement for comparison with the pre-procedure ct. It was noted that battery replacement was discussed and the patient decided to replace the battery in an effort to avoid surgery in the future. The left sided system (lead, extension, and battery) was replaced. Intraoperative impedances were within normal limits. Following replacement, the patient had excellent tremor control of the right hand. The patient outcome was reported as no injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1432330
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« Reply #16 on: January 19, 2014, 04:56:19 PM »

Model Number 7426
Device Problem No Information
Event Date 07/01/2009
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was reported that the pt experienced a lack of therapeutic effect. The pt symptoms included distortion of her mouth and a tense and contorted right hand. The symptoms were not attributed to any accident of incident. The pt's implantable neurostimulator was turned off by the pt's husband, and as a result, the pt was unable to move. The pt was hospitalized. Reprogramming was not conducted due to pt's current medication. The pt's status was considered "fair". Add'l info has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer's report# 30042091782000906057.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1462818
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« Reply #17 on: January 19, 2014, 04:57:03 PM »

Model Number 37612
Device Problem No Information
Event Type  Malfunction 
Event Description
It was reported that the pt's leg went out on them and they fell and hit their head while throwing something over a chair. This was followed by a drawer falling on them. It was also reported that the pt experienced cramping in their torso, arm, hands, and knees to toes. The cramps were alleviated with walking around. The pt had a history of blood clots. Additional 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=1494706
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« Reply #18 on: January 19, 2014, 11:04:36 PM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the patient experienced pain in their right hand when stimulation was on. The pain began following an accident. The patient also had a fused right thumb as a result of the accident. The patient turned off their stimulation and experienced a return of tremors. The patient has not undergone reprogramming as they had previously experienced a shocking sensation during programming. Additional information 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=1483535
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« Reply #19 on: January 19, 2014, 11:05:33 PM »

Model Number 7426
Device Problems High impedance; Inappropriate shock; Low impedance
Event Type  Malfunction 
Event Description
It was reported that the pt experienced a shocking sensation on the left side of their face which travels into hand and arm. The symptoms appeared following a tooth extraction on the right side of the pt's mouth. High and low impedances were reported. Impedances: c/0 >2000 8ua, c/1>2000 9ua, c/2 669 19, c/3 678 19 all bipolar pairs <50 and 223. Programmed c+1-, 2. 6v, 60 185.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463155
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« Reply #20 on: January 20, 2014, 01:25:34 AM »

Model Number 7426
Device Problems Electro-magnetic interference (EMI); Malfunction
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the pt experienced a loss of therapeutic effect following cauterization for a skin condition. It was noted that the pt experienced shaking in his hand. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476510
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« Reply #21 on: January 20, 2014, 11:41:21 PM »

Device Problem Failure to read input signal
Event Date 09/25/2009
Event Type  Injury   Patient Outcome  Other
Event Description
The pt visited the hospital and their battery status showed 3. 7 or 3. 8v. One week later the pt re-visited the hospital with shaking hands. It was impossible to take telemetry. The pt's device was explanted.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545798
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« Reply #22 on: January 20, 2014, 11:42:30 PM »

Model Number 7428
Event Date 01/01/2009
Event Type  Malfunction 
Event Description
The pt was pulled by a speed boat while sitting on an inflatable chair. The ride was jarring. Afterward, the pt felt unconformable. Her left hand was going into spasm and her tongue was twisting, making it difficult for her to speak. The pt felt disoriented. Interrogation with the pt programmer revealed that the amplitude of the deep brain stimulator unit was set to 1. 6 and 1. 1 volts. Prior to the ride it was 0. 5 and 0. 6 volts. The upper limit of stimulation was set to 1. 0 volt. The pt's condition had returned to normal once the device amplitude was turned back down. The pt had pain in her neck where the wires were. The pt had not had problems with her deep brain stimulator after participating in water sports before.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1521807
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« Reply #23 on: January 20, 2014, 11:44:39 PM »

Device Problem Malposition of device
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: richardson rm, ostrom jl, starr pa. Surgical repositioning of misplaced subthalamic electrodes in parkinson's disease: location of effective and ineffective leads. Stereotact funct neurosurg. 2009;87(5):297-303. Summary: this article reports a retrospective analysis of 8 pts with idiopathic parkinson's disease who underwent surgical lead revision of deep brain stimulation (dbs) leads placed in the subthalamic nucleus (stn) to gain insight into the boundaries for dbs lead position targeting for effective and ineffective stimulation. Reportable event: the pt experienced improved tremor and rigidity, but persistent gait imbalance and adverse effects of hand dystonia and diplopia. The lead was determined to not be optimally placed. Following unilateral lead revision, the pt had improved gait imbalance and no adverse effects.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562476
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« Reply #24 on: January 25, 2014, 03:10:22 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 08/30/2010
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that the pt experienced stimulation in the wrong location. While the device was on, the pt could not use her left hand due to the placement of the lead. The other lead was ok but not optimal. Additional information has been requested and will be made as f/u as it becomes available.

 
Manufacturer Narrative
Concomitant: product id 3387s-40, lot# v007141, implanted: (b)(6) 2006, product type lead; product id 3387s-40, lot# v007141, implanted: (b)(6) 2006, product type lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type extension; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

 
Event Description
Additional information received reported that the patient did not have good results originally. It was noted that the right brain lead was replaced because the original placement was not giving her tremor control on the left hand. 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=1850877
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« Reply #25 on: January 25, 2014, 03:10:57 PM »

Model Number 7426
Device Problem High impedance
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
The impedance measurements were greater than 2000 ohms on all of the unipolar pairs. The patient experienced a tingle sensation in opposite hand/arm when the neurostimulator was on. Further information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1831835
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« Reply #26 on: January 28, 2014, 09:35:09 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/27/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: denys d, mantione m, figee m, et al. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch gen psychiatry. Oct 2010;67(10): 1061-1068. Summary: the authors conducted a double-blind, sham-controlled trial to demonstrate that bilateral stimulation of the nucleus accumbens can be an effective and safe treatment in treatment-refractory pts with obsessive compulsive disorder (ocd). All pts underwent electrode implantation in the same target area, and stimulation settings were applied uniformity throughout the study. During the treatment period of 21 months, obsessive-compulsive symptoms decreased by 52%, and 9 of 16 pts responded, with a mean improvement of 72%. Anxiety and depressive symptoms decreased by half. The surgical procedure and stimulation were well tolerated. Permanent adverse events were limited to mild forgetfulness and word-finding problems. Increased libido was reported by several pts but may be interpreted as a return to normal functioning rather than an adverse event. Reportable event: one pt, ((b)(6) female), experienced a wound infection and numbness at the incision site. This pt also experienced tiredness, paresthesias in the hands and feet and hypomanic symptoms. The hypomania or elevated mood occurred shortly after the switch of the contact points from 0 or 1 to 2 or 3 and lasted for 2 days. Elevated mood or hypomania never required the addition of a mood stabilizer, and the adverse event was rated as mild. Elevated mood was frequently reported during reactivation of the stimulation after an off period. For this pt, the effect of stimulation was not subjectively noticeable. See literature article with mfr report# 3007566237201010486.

 
Manufacturer Narrative
(b)(4) (paresthesias of the hands and feet). At this time no additional info was available, additional info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1939551
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« Reply #27 on: February 07, 2014, 07:53:54 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 #28 on: June 07, 2014, 10:24:07 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.

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« Reply #29 on: July 05, 2014, 12:02:54 AM »

Model Number 7426
Event Type Injury Patient Outcome Required Intervention,Hospitalization Manufacturer Narrative
Concomitant medical products: product id 3387-28, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: lead. (b)(4).
Event Description
It was reported that 18 months prior to report, the impedance values of the patient¿s #0 and #2 electrodes suddenly decreased. It was further reported that this ¿resulted in high-power stimulation and the patient presented with symptoms of internal capsule stimulation. ¿ it was stated the patient¿s physician considered the ¿possibility of a lead problem¿ and it was decided to replace the patient¿s leads on (b)(6) 2014. It was reported that following the replacement of the lead, the patient¿s ¿impedance values had not changed at all. ¿ it was stated ¿the problem was not attributable to the lead¿ and ¿the physician did not know what might be a possible cause. ¿ additional information stated that when stimulation was performed on (b)(6) 2013 there ¿were fluctuations in the electric current value due to fluctuations in impedance. ¿ it was reported that when impedances were checked on (b)(6) 2013 ¿there were no problems with the left electrode¿ and that the right electrode¿s #0 and #2 had ¿low¿ impedances. Impedance records indicate the ¿low¿ values for contacts #0 and #2 were 346 ohms and 479 ohms respectively. It was stated the patient¿s ¿neck was still in pain¿ and that it was ¿difficult to face right. ¿ it was reported that ¿tension in the right dominant sternocleidomastoid (scm) was the most noticeable¿ and that it was also noticeable in the patient¿s right trapezius muscle. It was noted the patient had ¿botulinus administered on (b)(6) 2013 and that ¿it was difficult to control the patient¿s symptoms in their neck region, so botulinus was used concurrently. ¿ it was reported that ¿dystonia was not triggered through stimulation in the left finger like it was in the past. ¿ it was stated the patient had been previously hospitalized at a neurological hospital in (b)(6) 2012. It was further reported that impedance testing performed on (b)(6) 2014 found ¿low¿ impedances on electrodes #0 and #2 of 259 ohms and 356 ohms respectively ¿ both measured at 2. 5 volts. It was again noted these impedances were ¿too low. ¿ while performing stimulation testing it was reported the patient experienced their left hand being ¿heavy. ¿ it was stated the patient could not fully extend their fourth or fifth fingers at times during the test. Eventually it was noted the patient could extend their fourth finger ¿if done consciously. ¿ it was additionally reported that a surgery was performed on (b)(6) 2014 ¿to shift the dbs (deep brain stimulation) electrode on both sides. ¿ it was stated this was performed because ¿there was a problem with the electrode placement position itself¿ and ¿there was a concern about whether the impedance was low due to the dbs electrode. ¿ it was further stated there ¿seemed like there was a problem with the dbs electrode itself (disconnection?). ¿ it was reported that after the surgery to shift the electrodes, the impedances in the right electrodes #0 and #2 were ¿still low. ¿ the ¿low¿ therapeutic impedance values when measured at 3 volts were found to be 269 ohms and 374 ohms for electrodes #0 and #2 respectively. It was stated that ¿when the electric current was applied¿ the patient complained of ¿tingling sensations in the implantable neurostimulator (ins) region. ¿ it was further stated the patient reported the ¿ins was painful¿ and the ¿ins was tingling. ¿ it was reported it was ¿slightly difficult to extend [their] left fingers¿ and ¿slightly difficulty to bend [their] right fingers¿ during a stimulation test. It was additionally reported that during the stimulation test the patient¿s right upper limb and lower left limb were ¿slightly heavy¿ and the right bottom half of the patient¿s body ¿felt tingly and fuzzy. ¿ it was stated the patient¿s shoulder also felt ¿strained. ¿ impedance testing performed on (b)(6) 2014 indicated the right electrodes #0 and #2 had impedances of 294 ohms and 432 ohms respectively. Impedance testing also indicated the right bipolar electrode pair 1-3 had an impedance value ¿>2000¿ ohms. It was noted that electrodes #0 and #2 ¿were both five years old. ¿ additional information reported ¿electrode replacement surgery was performed, however, the resistance value was low and did not change. ¿ it was stated there was ¿possibly a problem with the electrode and there was a problem with the indwelling position of the lead as well. ¿ it was noted that on (b)(6) 2014 a lead was ¿extracted¿ and would be collected at a later date for analysis. It was additionally noted that ¿since the low resistance continues even after changing the ins and lead, the cause of the low resistance could be from the extension part. ¿ it was noted the patient was admitted to the hospital for ¿recovery¿ following their lead replacement procedure. Additional information stated ¿stinging sensations persisted¿ after the lead replacement was completed. Additional information stated the patient ¿had not had effective therapy¿ and the ¿cause was not determined¿ as of 17 days after initial report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3855294
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« Reply #30 on: August 10, 2014, 06:15:31 AM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# v157349, implanted: 2008 (b)(6); product type lead product id 7482a66, serial# (b)(4), implanted: 2008 (b)(6); product type extension (b)(4).

Event Description
It was reported a few days following the patient¿s replacement surgery, they noticed a tingling on their chest as well as up and down their right arm. It was noted, the lead was in the left ventral intermediate nucleus (vim). The patient¿s right hand and arm would kind of go into a ¿flailing mode¿ and it would affect their motor coordination. It was described as intermittent shocking symptoms. The old implantable neurostimulator (ins) was at the exact settings but at a lower amplitude. An electrode impedance test was performed and c0 showed high at 2360 ohms. It was noted the intermittent shocking occurred a few times a day and they could reproduce it if the patient pushed on the ins. When the patient pressed on the ins the impedance test was redone and c0 showed 1217 and the tingling sensation faded. It was noted the issue appeared with 0. It was further reported on the day of report in the operating room they tried to re-enact the impedances but it showed normal the entire time. It was noted the doctor went ahead and replaced the ins on the day of report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3922599
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« Reply #31 on: September 06, 2014, 12:37:05 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013492
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« Reply #32 on: September 06, 2014, 02:20:34 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013492
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« Reply #33 on: September 06, 2014, 05:05:21 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0arp9, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0bbqp, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).
Event Description
It was reported that the patient¿s hands had started to clasp together during the night since (b)(6) 2013. After that, three months after implant, the patient began falling a lot. The patient fell once or twice a day and in (b)(6) 2014 he broke his leg. The patient had not fallen since that time. The patient had lost a lot of coordination and stumbled when he walked. The patient would hold on to something when he walked to keep himself more stable. This issue had been happening for ¿a while,¿ but the patient could not provide an exact date, and he thought his coordination could be getting worse. The healthcare provider (hcp) thought the cause of the event was gait ataxia or possible orthostatic hypotension with polyneuropathy. The therapy was still working for the patient¿s tremors. The patient had an appointment scheduled with his implant surgeon for (b)(6) 2014. Medical intervention and the patient outcome were not reported, so additional information was requested. If additional information is received, a supplemental report will be sent. Refer to manufacturing report #3004209178-2014-15622 as the patient had two ins¿s and it was not specified which was the issue.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4024800
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« Reply #34 on: October 12, 2014, 06:11:41 AM »

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

Event Description
It was reported the patient had an implantable neurostimulator (ins) revision due to normal battery depletion and their healthcare professional (hcp) put in ¿a new type of battery that does not agree with deep brain stimulation¿ and the patient was rejecting the deep brain stimulation therapy. The reporter stated the ins was called ¿fl series¿ and the hcp told them it was a different type of battery than what the patient had implanted before. Prior to the ins replacement the patient was fine, but now they ¿could not do any of that. ¿ the patient¿s ins could not be programmed to the settings that it should have, which was 4. 0 because the patient¿s upper lip curled up and their hands tingled. The patient had contacted an hcp. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4096519
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« Reply #35 on: October 13, 2014, 12:33:16 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v230715, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

Event Description
It was reported that the patient had a stimulator in her chest for essential tremors with parkinson¿s. There was a loss of therapeutic effect. There was a sudden onset of symptoms. Onset was following the patient¿s neighbor had started up a lawn mower while the patient was sitting outside reading a paper and it was so loud and the patient had not known until it was too late, the damage had already been done. The patient had not gone anywhere when this had occurred on the day prior to the date of this report, she had not even left the house. Patient symptoms included tingles down her arm, legs and face, a dull ache in her left ear that she had after surgery and it was back the time of this report and hearing issues. The patient was right handed and the implant was in her left chest. The patient¿s right hand was usually very steady, but was shaking at the time of this report. The patient was unable to hold a toothbrush, fork, a pen or anything. The patient checked her device and it said on with a black triangle and the patient checked again and it said on and ok. The patient had checked her device twice on the day prior to the date of this report to make sure she was on and it was. There had been no problems with the patient¿s previous stimulator, which the patient had for 5 years before having it replaced and the current stimulator had been nothing, but problems/issues. The patient had issues with it since (b)(6) 2014 when it was implanted. The patient looked as though she had a pack of cigarettes sticking out of her chest and the wires looked like they were sticking out of her neck and had not before. The incision was healed and there was no tenderness or redness over the scar. Prior to (b)(6) 2014, the patient had been getting control of her symptoms, but it had been sending her into circles, which meant she was dizzy and had shakes in her right and left hand and pin pricks all over her legs and arms. A healthcare professional had instructed her to turn stimulation on and leave it on and not to turn stimulation off at night in order to prevent side effect. The patient would experience the ¿circles¿ when she had the device off and turned it back on. No interventions or outcome were provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078338
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« Reply #36 on: October 13, 2014, 01:58:54 AM »

Model Number 7426
Event Type Malfunction
Event Description
It was reported that the patient was complaining of the device spontaneously turning off. The device was turned back on at the healthcare providers (hcp) office. Testing was completed including battery voltage and impedances and both were normal and within range. Reprogramming was also completed. Before the patient left the office, the device had turned off again. Then it was then turned on, as well before the patient left. When the patient was home, the device powered of again, and then the patient turned in back on with his hand held patient programmer. The patient status at the time of report was alive with no injury. It was later reported that the patient was having trouble with holding silverware to have breakfast the morning of the report due to his hand shaking. The patient noted that (b)(6) his hands were shaking more and then got relief in the right hand by adjustment. It was then reported that a battery was purchased for the patient programmer, the ins was off, and then the patient turned stimulation back on. The patient felt a shock in his arm, which was noted to be normal when the implant was turned back on. Then, the patient was getting control of his hand again and was receiving effective therapy.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v354660, implanted: (b)(6) 2009, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078222
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« Reply #37 on: November 08, 2014, 08:36:48 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead. Product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead. Product id: 748295, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 7482a95, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient saw a ¿call you doctor¿ end of service (eos) message on his programmer. He saw the message on the day of the report and was unable to adjust stimulation or get it to turn on. The patient experienced a sudden loss of therapeutic effect and stimulation. His left hand started shaking, so he grabbed the programmer to check the status and saw the message. Follow-up from the healthcare provider (hcp) reported that there was not 50% or greater symptom reduction. Reprogramming was not needed as the event was due to end of battery life. It was later reported to be premature battery depletion. Impedance testing was done and the ins showed a short on contact 1 and 3. The patient was reprogrammed in (b)(6) to these parameters and this may have been the cause of early depletion. The ins was replaced. Follow-up from the patient reported that he did have concerns with his device or therapy. The patient wanted to know why the ins had a shortage and did not last as long as the last one. This led to the patient questioning how long the new ins would last. However, he noted that new ins worked fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4143638
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« Reply #38 on: November 08, 2014, 08:37:23 AM »

Model Number 37602
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389-40, lot# j0340291v, implanted: (b)(6) 2003, product type: lead; product id 748295, serial# (b)(4), implanted: (b)(6) 2005, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389-40, lot# j0337392v, implanted: (b)(6) 2003, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. (b)(4). F.

Event Description
It was reported that the patient was having spasms in her hands and arms on the night prior to the date of this report. The patient had used her medic alert necklace on the day prior to the date of this report. The necklace was taken off on the morning of the date of this report and the patient had not had spasms in her hands and arms. The patient was going to try and put the necklace back on to see what would happen. No outcome was provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2014-18142.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4134805
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« Reply #39 on: December 05, 2014, 11:54:56 PM »

Model Number 37602
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0jy0m, implanted: (b)(6) 2014, product type: lead. Product id: 748351, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0g100, implanted: (b)(6) 2014, product type: lead. Product id: 748351, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
It was reported that there was a loss of therapeutic effect, the patient¿s hand had been shaking badly and ¿like crazy¿ for about 3 weeks prior to the date of this report. The patient thought something electrical had turned her implant off and did not have the programmer to check. The patient¿s status was unknown. The patient¿s programmer had been lost or stolen and she could not wait to get a new one. No patient outcome was provided regarding the event. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2014-20904.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4224171
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« Reply #40 on: January 10, 2015, 02:18:31 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7436, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v281324, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v268107, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 7436, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient¿s therapy wasn¿t as good as it used to be. The patient noticed this change a couple of years ago. The patient had a hard time walking and his hands shake more. His head was shaking but not as bad as it was prior to implant. The patient had set up appointments in the past, but never went to them. The patient had a follow up appointment on (b)(6) 2013. There was also a problem with the patient programmer. It had last worked a week prior. It was later reported when the patient had first had the device put in they had had a problem with the top of their head. The patient could feel electricity when they put it on but that had gone away. The patient had tremor. The patient had felt great after the first operation but now had not, the patient still could not write and had been shaking ever since she was young. It was unknown when the implantable neurostimulator (ins) had become less effective. It was noted that when the patient was in the army it was not bad and the patient sort of hid the shaking. The patient was a wreck. The patient had not felt quite as great as he should for quite a while. The patient¿s device was replaced on the day prior to the date of this report.

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« Reply #41 on: January 10, 2015, 03:16:01 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had unilateral lead placement to control tremor with good response initially. It had been observed that after 4 to 6 weeks, the patient experienced ¿rapid habituation¿ of the current, and their tremor returned within 4 days and it was ¿to the same extent that it was prior to the device¿ but ¿not as bad as the refractory tremor. ¿ this had reportedly been a ¿constant cycle¿ and became a concern as the patient reached 6v in bipolar mode and "bordered on" the patient experiencing a ¿capsular effect. ¿ this ¿capsular effect¿ was clarified to mean ¿voice, speech, double vision as well as a hot and cold sensation. ¿ other experiences that had increased since having the device included tremor, inbalance, headache, arm aching, ¿clammy hands¿, contracture of the hand, exhaustion from tremor and inability to hold cutlery. It was also noted that when the patient¿s device was turned off, he had a ¿severe¿ refractory tremor, far worse than it was prior to the device. This was ¿so violent¿ that it could only be turned off for a minute. There had been no falls or trauma prior to noticing this. The physician feared that it could be morphology of the disease. The reporter indicated that initial thresholding was done but electrode configuration had remained the same at a setting of 90's, 130 hz on electrode pair 0-,1+. The amplitude had been increased from 2. 2v to 6. 4 in several increments. Threshold testing had been performed again, but to no avail. All electrode and therapy impedances were normal for all testing done with the patient in a rested position, arms up and head to the side. Additionally, no error messages had been observed on either the clinician or patient programmers. The patient was admitted to the hospital for further tests and was placed on constant current mode at 4. 6a under observation. A ct scan was performed which showed ¿perfect lead placement within the proposed target. ¿ the patient had also undergone ¿some more testing¿, details of which were not available at the time of the report. The patient had however not had any ¿positive change¿ yet. Discussions about the possibility of creating a "lesion effect" with the lead were underway. The reporter stated that the implantable neurostimulator (ins) was going to be replaced. If additional information becomes available, a follow-up report will be submitted.

Manufacturer Narrative
Concomitant products: product id 37085-40, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3387-40, lot # 0208456401, implanted: (b)(6) 2014, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334699
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« Reply #42 on: January 10, 2015, 04:09:13 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was a loss of therapeutic effect, the patient¿s left hand had begun to shake and they had found a wire was broken. It was unknown when it had broken but the shaking had begun in (b)(6) of 2010. The patient had put up with it and had said it had not bothered him. The patient¿s hand would turn in and he would keep it closed. The lead and implantable neurostimulator (ins) were replaced and the issue was resolved. The patient had it adjusted and then had never had to go back again.

Manufacturer Narrative
Concomitant medical products: product id: 3387-40, lot# v003141, implanted: (b)(6) 2006, product type: lead. Product id: 3387-40, lot# v001355, implanted: (b)(6) 2006, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4333043
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« Reply #43 on: February 07, 2015, 06:47:30 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported the parkinson's disease patient¿s implantable neurostimulator (ins) battery was found to have been depleted when checked in (b)(6) 2012. The ins was then replaced on (b)(6) 2012. The patient was reportedly told by their implanting doctor the ins could be used for eight years and they were wondering why it was ¿only used for about four years. ¿ it was ¿unknown¿ whether the battery depletion was considered normal. It was also noted the patient had experienced their hands shaking. Additional information was requested; a supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4471012
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« Reply #44 on: February 07, 2015, 06:48:09 AM »

Model Number 7428
Event Type Malfunction
Manufacturer Narrative
Product id 7436, serial# (b)(4); product type programmer, patient product id 7 482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v479548, implanted: 2010 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v591417, implanted: 2010 (b)(6); product type lead. (b)(4).

Event Description
It was reported that it had been a while since the patient had used the programmer and that they had never reviewed how to use it. There was a loss of therapeutic effect. Symptoms had a sudden onset about 2-3 days prior to the date of this report and he was not able to write because his hands had started shaking. There was no known accident or incident related to the complaint. The patient had gone to his healthcare professional and brought the programmer with him. The internal device was checked and he was told to start using the programmer again since he had not used it in a long time. It was noted that once he had given himself a treatment the shaking stopped. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4404816
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« Reply #45 on: February 07, 2015, 06:48:49 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported the patient had been having trouble with their left hand getting shocked for a week. The patient had seen their healthcare professional (hcp) and they had run tests on the implantable neurostimulator (ins), but they were unable to give them any relief. The hcp had contacted another hcp that stated this type of shocking usually indicated a fault in one of the leads in the brain. The patient stated they were facing surgery probably in the next two weeks, but they were not sure when it would be. The patient stated the right lead was 15 years old so maybe it was worn out. The patient was trying to get an appointment with the mayo clinic at the time of this report. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 3389-40, lot# l73653, implanted: (b)(6) 1999, product type: lead; product id 37612, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3389-40, lot# l73653, implanted: (b)(6) 1999, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension; product id 7482a40, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387s-40, lot# v046959, implanted: (b)(6) 2007, product type: lead; product id neu_ptm_prog, serial# unknown, product type: programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4399488
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« Reply #46 on: February 07, 2015, 11:21:23 AM »

Model Number 37601
Event Date 11/10/2014
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had experienced her hands trembling. The patient was reprogrammed on (b)(6) 2014 and reportedly her ¿symptoms got better after programming. ¿ then, five days prior to report, the ¿patient fell down because her legs were weak. ¿ the patient went to the hospital to be reprogrammed nine days after initial report as a result; however, the patient¿s physician ¿didn¿t do any parameter adjustments¿ at that time. The physician examined the patient and told the patient she ¿had brain stem and suggested to do programming after the brain stem was cured. ¿ the patient was hospitalized the following day ¿for treatment of brain stem. ¿ it was noted the patients legs ¿were still weak¿ at that time and that the physician ¿said the symptom was caused by brain stem. ¿ it was ¿unknown¿ whether the patient was receiving 50% or greater symptom reduction at that time. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377420
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« Reply #47 on: March 07, 2015, 04:42:04 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had the following symptoms: altered mental status, burning sensation, change in gait, difficulty walking, leg dragging and swelling. The patient¿s stimulation had to be turned up pretty high in order to control his tremor. Sometimes when it was so high he had a burning sensation in his face. When stimulation was turned off he still felt the burning sensation and he wanted to know if this was normal and if it was possible that it could cause permanent damage. When stimulation was turned off it took a couple of days for the burning to stop. The burning in the patient¿s face had started sometime in early to mid-(b)(6) 2014. There was a spot right about his lip that took longer to have the burning go away and sometimes it would take about a month before the burning stopped. The patient had two leads, one on the right and one on the left that were both connected to an one implantable neurostimulator (ins) which was in his left chest. The patient was told that in order to help with the progressive tremor and the burning in his face they would need to implant a 3rd lead and another ins in the other side chest and the patient was inquiring if this was normal. The patient¿s tremor was progressing and he was able to tell weekly because the tremor was moving and increasing. The patient¿s left hand was getting worse and he gait was also changing. Sometimes the patient had voice trouble, with tremor in his voice and sporadically he had uncontrollable tremor with his head and eye lids. The stimulation had worked at controlling his symptoms for a few months but the tremor had been gradually increasing so the patient was unsure if it was a stimulation issue or a symptom issue. Amplitude was set at 1. 3 volts on the right side of the brain. The patient had a fall a couple of weeks prior to the date of this report, the patient stated that he had many ¿almost falls¿ but the last one was a couple of weeks prior to the date of this report. It was noted that it had been a nightmare since day one. The patient stated that when the leads were put in the brain he had an edema of the brain and they were not sure what the swelling was from but the patient had brain damage from the swelling. After the implant they had brain swelling. The patient had blood clots from being down for so long. Also, the patient was unable to use the right side of his body for a few days after the surgery. The patient zoned out, the nurse would bring the patient into a dark room and he would not be able to figure out what he was supposed to do until he was directed to turn on the light. The patient had stated that it was like he knew what to do but would get stuck in between what he should do and how to do it. On occasion he would have to use the left hand to move the right hand and also he would want to use his right hand but he wouldn¿t know how to use it. The patient was able to walk normal but sometimes his leg would drag. Most of the time it was the left leg that would drag but it would also be the right as well but the left was worse. Following implant of the leads the patient was already having problems before he even got home. It was so bad that his wife brought him to the emergency room. It was noted that while at the emergency room the patient was so thirsty, he got up and walked over to the faucet; he could hear the water gurgling in the pipes but forgot to turn on the water so he was trying to suck the water out of the faucet. The patient would drift in and out of reality. The patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative. The patient had an appointment scheduled but the date was illegible. No outcome or intervention was reported. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. 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: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515835
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« Reply #48 on: April 19, 2015, 02:23:20 AM »

Model Number 37601
Event Date 01/24/2014
Event Type Injury
Manufacturer Narrative
Concomitant: product id neu_unknown_lead, product type lead. (b)(4).

Event Description
It was reported that the patient experienced shaking in the hands, rigidity in the legs, and a lisp after an implantable neurostimulator (ins) replacement on 2014-(b)(6). In (b)(6) 2014, the patient took mri films to a new physician who indicated the target location of the lead was ¿not accurate¿ and a second surgery was recommended. The patient¿s implanting physician believed there wasn¿t a problem with the target position. The patient wants to have a second surgery but no date for the surgery had been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4637974
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« Reply #49 on: June 08, 2015, 07:13:22 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4774612
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« Reply #50 on: July 15, 2015, 11:50:07 PM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 7436, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v239714, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v279715, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

Event Description
It was reported the patient went to have an electrocardiogram (ecg) done in (b)(6) 2015 and prior to the ecg the cardiologist passed a magnet over the patient¿s pacemaker. The patient immediately began having seizure like movement called dystonic. The patient had drooping on one side of their face and the face was distorted, their speech was allured, and their right hand tightened and twisted, and their handwriting was affected on the right side. The slurred speech and the patient¿s face sagging lasted for about an hour. The patient was admitted to the hospital and they spent the night there for observation. Since the ecg, the patient had been tired and they were very anxious about having anything done to the pacemaker. The reporter stated the ¿seizure thing¿ was brief and stopped soon, the drooping in the face continued for a couple weeks, and the patient¿s hand writing gradually got better. In the past, the patient has had ecgs without interference. Since the patient last saw their healthcare professional (hcp) in 2010, they had not turned their devices off or made any adjustments to settings. Someone in the patient¿s assisted living center checks the devices with the patient programmer and last fall they could not get it to work so they stopped checking it. The patient was checked by their neurologist and they said the patient had dystonia. The hcp was not sure why this happened. The hcp thought the patient¿s implantable neurostimulators (ins) should be depleted by now, but the devices were tested and they were working, but low. The patient had not had a return of tremor so they did not see their hcp until now. The ins was on and working well. The ins battery was low at 2. 29v and the patient programmer did not show any lights indicating the battery was low. Impedances were measured to be normal. If the patient¿s tremor returned, they were going to schedule an appointment to have the ins replaced. The patient was about to have another ecg again and the nurse stated they could try turning the ins off and then back on. The nurse also mentioned using a pie plate to shield the magnet from the device. The patient did not have the symptoms of tremors before. The patient¿s hcp later reported the patient had a 50 percent or greater symptom reduction and they had recovered without permanent impairment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4870903
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« Reply #51 on: August 08, 2015, 08:25:25 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
The arrangement of the patient¿s stimulation was unusual in that he developed high impedance on all the leads to the left of them as well as a disappointing functional response with tremor in his right hand occurring as he wielded his tools in a pale beating job. The lead was re-implanted in the left posterior subthalamic area and connected to the implantable neurostimulator (ins). This occurred in (b)(6) 2013. If additional information is received, a follow up report will be sent.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4882240
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« Reply #52 on: August 08, 2015, 08:26:13 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking sensation and shooting painful stimulation in their chest, arm, and hand. The patient was fine until about two weeks prior to this report. Over the weekend prior to this report, the patient went to the emergency room due to pain in their chest and a change in their issue. Stimulation was turned off in the emergency room and the pain went away. During the visit, an elective replacement indicator (eri) message was displayed. The implantable neurostimulator (ins) was at 2. 56v. A manufacturing representative met with the patient on the day of this report and the ins was turned off. Impedances were measured and there was nothing out of the ordinary. During the impedance measurement, the patient felt shooting pain. The ins was programmed to 1+, 2- at 4v, 90 usec, and 185 hz. No recent car accidents or falls were noted. The patient did not experience symptoms when the ins was turned off. The manufacturing representative attempted to turn stimulation on and they got to 1. 4v when the patient felt stimulation in their arm and hand. The patient had an appointment scheduled with a surgeon on (b)(6) 2015 to discuss replacement of the ins since the ins was at eri. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent. Refer to manufacturer report #3004209178-2015-13638.

Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient; product id 3387s-40, lot# va02nm4, implanted: (b)(6) 2012, product type: lead; product id 7482a95, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387-40, lot# j0401949v, 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), implanted: (b)(6) 2004, product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4924887
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« Reply #53 on: September 07, 2015, 07:46:23 AM »

Model Number 37603
Device Problem Communication or transmission issue
Event Date 07/21/2015
Event Type Malfunction
Manufacturer Narrative
Product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead. (b)(4).

Event Description
A consumer reported that a poor communication screen was displayed on the patient programmer and the patient was getting poor communication. The patient was recently implanted and bandages and some swelling was present. On the day of this report, the patient met with a nurse for their health care provider and they turned down settings a little bit. Since the settings were turned down, the patient's hand was shaking really bad and the shaking was terrible. The shaking had started the day prior to this report and had gone away, but it was back today. The patient only had shaking in their hand and it was gradually getting worse. On 2015 (b)(6), the patient had cramping in their leg. The patient's indication for use is essential tremor and movement disorders. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5010764
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« Reply #54 on: September 07, 2015, 07:47:29 AM »

Model Number 37603
Device Problems Failure to interrogate; Device displays error message; Communication or transmission issue; Electromagnetic compatibility issue
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, product type: extension. Product id: 3389, product type: lead. (b)(4).

Event Description
The patient reported that symptom returned. The patient was implanted for essential tremors on the right side. The patient had good reduction in symptoms right after first programming on (b)(6), then 24 hours later the patient started having problems. It was also noted that the programming has gone well and the patient received good benefit. The programmer reads the setting was being in service, however, tremor has returned and no relief of symptoms. The patient was driving and then his tremors returned. When the patient returned home, he turned the device off then turned device on, no changes. "they have changes setting not change in symptoms". It was confirmed that the patient has not fallen or accidentally hit his device, no trauma. The patient did contact his clinic. Two days later the patient was seen at his doctor's office and the ins was checked with the clinician programmer. The ins was working as planned. The patient came back for reprogramming. Less than a week later the patient's health care provider (hcp) reported a loss of therapy. It has happened twice now, where all of a sudden, the patient's tremor was no longer controlled by the ins. The patient went to his doctor for a final adjustment. The device was working for only 24 hours. The programmer indicated the ins was on and working. The patient has an insulin pump that he clips to his shirt collar on the opposite side of his chest from the implantable neurostimulator (ins). When the clip is close to the ins, the patient programmer (pp) will not read the ins nor will the pp work. The patient knows the device is on as he feels tingling in his right arm when the stimulation is on. The patient was not feeling any tingling in his hand when device comes on like he used to. When the insulin pump was clipped to the patient's belt, it does not affect the ins and the pp from communicating. The hcp was told that the ins was on but the patient verified that he has been playing with the settings via the pp. It was further stated that the tremor came back, even with the program running but the patient had shut the system off, as nothing they did seemed to work. The hcp turned it on and the patient felt the program start once again. The patient drove all the way home and it happened again; program on and tremor back. The system was interrogated; no codes and no impedance issue. Emi compatibility guidelines were requested. The following is the patient's diary information for (b)(6) 2015: 5:40 pm - on at 2. 00 then up to 2. 80 -nothing then up to 3. 40 - big buzz up arm then down to 2. 8 - cue test worked 5:45 - down to 2. 00 -seems to work but not with cue then up to 2. 60 - buzz - 90% with cue then up to 2. 80 - buzz - 90% with cue 5:50 - down to 2. 00 - turned off and out of regulation error message 00r with phone to doctor shown on page 106 appeared 7:05 - turned on at 2. 00 - buzz then up to 2. 80 - felt no difference - no help with cue then down to 2. 00 - seemed to be working then up to 3. 40 - buzz then down to 2. 80 - no help with cue then down to 2. 00 - not sure its working 8:30 - using my left hand, i pulled my head toward my left shoulder and felt a buzz in my right hand 9:55 -changed from 2. 00 to 2. 80 - felt a buzz and worked with cue back to 2. 00 from 2. 80 - hand writing feels better turned off note: between 8:30 and 9:55 i sometimes got a buzz when yawning. Cue was referring to the patient's pool cue when he checks to see if he can play "snooker. " the next day the hcp reported again a change in the patient's therapy. The change was considered sudden but also reported as gradual. The patient continues to have intermittent therapy/tremor, tremor comes and goes; and intermittent return of symptoms and tingling in right hand. The hcp has tried different scenarios and was not able to replicate the problem the patient had. The device was off when the patient arrived at the clinic. The hcp turned the device on with the remote and the ins was interrogated, no codes were present. The patient felt a sensation in his right arm, and noticed a reduction of tremor. The patient's wife is confident with the navigation of the pp. The hcp asked the patient's wife to leave the pp on over the next several weeks, and just push the orange button when they need to check the status of the program, or to turn the device off at night; they can push the off switch. Impedances were tested at 1. 5v and c-0 were >10k; when turning head to the right contacts 1-2 were 195ohms and when turning to left no problem. Telemetry strips showed c<(>&<)>0 were >20,000 ohms and 1<(>&<)>2 were 196 ohms. Change in therapy was related to positional movement. The patient sometimes feels tingling in his right hand. The hcp will try palpating the ins and extension connection to determine location of the problem. After doing some further diagnostic testing with the patient, putting strain on the lead/extension connection, a short circuit with 1 <(>&<)>2 and open with c<(>&<)>0. The implanting hcp will be taking the patient to the or and open up the lead/extension site to see if fluid got in the connection. The hcp will most likely replace the extension. Further information was requested but the hcp returns to the office on 08/05/2015. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4988000
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« Reply #55 on: September 07, 2015, 07:48:21 AM »

Model Number 37603
Event Date 09/06/2011
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v750613, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

Event Description
The consumer reported that her device was off at the time of the report as it was not helping her. The patient planned to go to her doctor the week after the report to get it looked at. Additional information from the consumer reported she had many concerns- side effects etc. As of (b)(6) 2011, her concerns were not resolved. The patient still had concerns regarding her device and therapy but she was working with her doctor/ manufacturer's representative. An appointment was set for (b)(6) 2012. The patient went in for her appointment and the device was interrogated by the hcp. The device was turned off on (b)(6) 2012 for mri. She had not been using the system due to poor tremor control. The patient was scheduled for surgery on (b)(6) 2012 for 2nd gpi lead replacement/ revision, a manufacturer's representative was to be present at the surgery. The first lead at the ventral intermediate nucleus (vim) was not enough to control tremor; the second vim lead was placed with the primary cell (pc), dual battery. The tremor was under control, the outcome was great. The patient never had therapeutic effect, she had tremors in her right hand and head, poor speech and her balance was off. There was speech decrease and poor lead placement. The first lead that was put in didn't work so well so the doctor put in another one. It was noted that the patient had 1 lead placed in the left side of the brain then the other lead was placed next to that lead because of lead placement. The patient had two leads in the same hemisphere/ target area for tremor control. The hcp initially went to insert a 2nd probe into the subthalamic nucleus but when they were doing the procedure; the hcp realized it was not having any effect on the tremors. They decided to reinsert another probe into the same nucleus at first. The 2nd probe was giving 70-80% relief from the tremors in her right hand. No further information was reported. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004132
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dennis100
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« Reply #56 on: September 19, 2015, 02:38:30 AM »

Model Number 37612
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 37651, serial # (b)(4), product type recharger; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension. (b)(4).

Event Description
A consumer reported that the patient whose indication for use was parkinson¿s dual and movement disorders had had a fall on (b)(6) 2015 and broke two fingers on the right hand and starting on (b)(6) 2014 the patient had a loss of stimulation and a return of shaking. The shaking the patient was experiencing was in both legs and the right hand. It was unknown what the patient was doing when they had lost therapy. The device was checked with the patient programmer and stimulation was on. The patient does not have the ability to adjust stimulation. Follow-up is being conducted to obtain information about troubleshooting done. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5042386
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