Pages: [1] 2  All   Go Down
Print
Author Topic: Deep brain stimulator - Hand  (Read 24144 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3796324
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
Pages: [1] 2  All   Go Up
Print
Jump to: