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Author Topic: Deep brain stimulator - Feet  (Read 5939 times)
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dennis100
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« on: January 14, 2014, 12:38:05 PM »

Model Number 7426
Device Problem Device remains implanted
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported the patient's left foot has dropped since the patient was implanted with their deep brain stimulator. The patient was implanted with the dbs device to treat parkinson's disease. Additional information has been requested, but was unavailable on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1082494
« Last Edit: February 07, 2015, 09:15:54 AM by dennis100 » Logged
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« Reply #1 on: January 14, 2014, 07:56:19 PM »

Model Number 7426
Device Problems Device remains implanted; Malfunction
Event Date 09/29/2008
Event Type  Malfunction  
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a sudden loss of therapeutic effect on one side (unspecified) of the dual dbs system. The status of one dbs system was checked with the patient programmer and was fine. The other side was unable to be checked with the patient programmer. When attempting to verify programming there was no action only the battery light. The patient had not seen their physician for a couple of months but was scheduled to see them next month and had contacted the physicians office about the problem. The symptoms started all of a sudden in 2008. The patient had a return of symptoms, couldn't walk, feet would point out in opposite directions, was sweating, thirsty, and had increased pain. It was unknown if it was the right or left dbs system that was indicated in the event. The patient remained at home in fair condition. Additional information has been requested, but was not available on the date of this report. See mfr report #3004209178200807008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216402
« Last Edit: February 07, 2015, 09:16:18 AM by dennis100 » Logged
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« Reply #2 on: January 14, 2014, 11:13:44 PM »

Model Number 7426
Device Problem Implant, repositioning of
Event Type  Injury  
Patient Outcome  Other,Required Intervention
Event Description
Journal reference: lind g, schenchtmann g, lind c, winter j, meyerson ba, linderoth b. Subthalamic stimulation for essential tremor. Short- and long-term results and critical target area. Stereotact funct neurosurg. 2008;86(4):253-258. In order to explore the usefulness and long-term result of subthalamic nucleus (stn) stimulation for the treatment of essential tremor (et), we evaluated 3 groups of patients undergoing deep brain stimulation (dbs) for et. Group 1 consisted of 3 patients undergoing deep brain stimulation (dbs) for et. Group 1 consisted of 3 patients who 9 years ago at intra-operative testing had good tremor reduction from stn stimulation. The second group consisted of 10 patients treated with dbs in the ventral intermediate (vim) nucleus of the thalamus. The third group compromised 9 patients subjected to stn stimulation for et with 1-3 years of follow-up. Reportable event: group 3. One patient, developed a dystonic twist of his right foot on stimulation, necessitating relocation of the dbs electrode to the vim, with the disappearance of the side effect and somewhat diminished tremor reduction. See mfg report 2182207-2008-05821.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1162706
« Last Edit: February 07, 2015, 09:16:56 AM by dennis100 » Logged
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« Reply #3 on: January 17, 2014, 11:23:34 PM »

Model Number 7426
Device Problems Other (for use when an appropriate device code cannot be identified); Implant, reprogramming of
Event Date 02/11/2009
Event Type  Malfunction  
Event Description
The pt stated having dystonia symptoms starting 2 days post implant in his legs and feet. The deep brain stimulator was reprogrammed frequently. The hcp had taken the pt on and off his parkinson's disease medications several times. The pt experienced symptom relief but had dyskinesia at an amplitude of 2. 5 volts. When the amplitude was lowered to 2. 1 volts and the pt felt some dyskinesia but also had a return of symptoms. The field representative reported that while doing a normal impedance check, the voltage changed from 2. 1 volts to 1. 5 volts. The pulse width and rate returned to default settings (210 microseconds, 30 hertz). Pt symptoms associated with the event included left-sided dystonia, dyskinesia, difficulty breathing, talking, and a voice change. The pt kept the deep brain stimulator turned off due to the dystonia symptoms. Please see mfr report #3004209178200901699. 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=1386114
« Last Edit: February 07, 2015, 09:17:27 AM by dennis100 » Logged
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« Reply #4 on: January 18, 2014, 04:18:36 AM »

Model Number 7426
Device Problems Lead(s), breakage of; Migration of device or device component; Implant, reprogramming of
Event Date 11/01/2008
Event Type  Malfunction  
Event Description
It was reported that the patient experienced chest pain in the middle and right side of the chest while the stimulation was turned, when the physician increased the pulse rate from 4. 5 to 4. 8. The pain subsided when the stimulation was turned off. The voltage was decreased on the left side. The patient was seen a week later, and reported pain in the right side of the back in the thoracic area. No changes to programming were noted. A week later, the patient had a botox injection, which resulted in less pain. The patient reported no "seizure-like episodes". No changes were made. Two weeks later, the patient noted painful contractions in the left forearm and left foot. No changes were made to programming. The patient was going into swimming courses. Several months later, it was reported that the entire system was scheduled to be replaced. X-rays revealed that the connector had been pulled down approximately 3 inches from behind the ear into the next region, and the lead was fractured and there were problems with the impedances. No patient outcome was reported. Reference manufacturer's report #3004209178200903788.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458863
« Last Edit: February 07, 2015, 09:17:55 AM by dennis100 » Logged
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« Reply #5 on: January 25, 2014, 03:15:49 PM »

Model Number 7426
Device Problem Device stops intermittently
Event Date 08/01/2010
Event Type  Malfunction  
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a pt's device had turned off unexpectedly. The pt was able to turn the device back on. It was unk what had caused the device to turn off. The pt's outcome was not reported, nor if any symptoms were experienced. Additional info is being requested, and will be provided in a follow-up report as it becomes available.

Manufacturer Narrative
(b)(4).

Event Description
Additional information was received from the patient's family member that reported about two summers ago the patient experienced twitching and tremors on the left side of his body. The patient's foot was also 'walking in. ' when the left ins was checked, it was found to be off. The patient's physician believed the ins turned off because the patient may have been close to a power line or magnetic strip of a refrigerator. The ins was turned back on successfully. 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=1839941
« Last Edit: February 07, 2015, 09:18:34 AM by dennis100 » Logged
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« Reply #6 on: January 28, 2014, 09:32:55 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
« Last Edit: February 07, 2015, 09:19:14 AM by dennis100 » Logged
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« Reply #7 on: February 07, 2014, 07:52:27 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. Doi: 10. 1016/j. Parkreldis. 2013. 07. 022. 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 had one electrode placed in the ventral intermediate nucleus (vim) and a second electrode placed intraoperatively in the zona incerta (zi). The reporter stated that intraoperative zi stimulation reportedly caused pyramidal tract problems, including left foot pulling and pain, dizziness, apprehension, and facial contracture. It was noted that vim stimulation alone resulted in 80% reduction of the patient¿s tremor with minimal side effects, resulting in removal of the zi lead and leaving only the vim lead. The patient reportedly experienced stimulation-associated side effects including some dystonic 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 wire, which resulted in significantly improved 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=3571916
« Last Edit: February 07, 2015, 09:19:49 AM by dennis100 » Logged
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« Reply #8 on: April 10, 2014, 12:40:23 PM »

Model Number 7426
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported the patient had a loss of therapeutic effect which she noticed yesterday and had gotten worse today. The patient¿s feet were numb and her toes were turning under. The patient thought her stimulation was off and had stopped working. The implantable neurostimulator (ins) battery status light on the patient programmer (pp) was blank with no light. It was noted the patient had an appointment in two days and she had left a voicemail for her physician. It was also noted the patient had changed the 9 volt battery in her pp yesterday. Additional information received reported the patient did not have concerns with their device or therapy. Patient had received assistance from their healthcare professional or manufacturing representative at an appointment on (b)(6) 2014. Patient was still having concerns with their device but was working with their healthcare professional or manufacturing representative due to having a battery replacement on (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3693759
« Last Edit: February 07, 2015, 09:20:15 AM by dennis100 » Logged
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« Reply #9 on: October 13, 2014, 02:00:36 AM »

Model Number 37603
Event Date 08/15/2014
Event Type Malfunction
Event Description
It was reported they were unable to adjust stimulation. They questioned whether the stimulation was on or not. The device was powered off. Troubleshooting occurred and using the on/off controls they were able to resolve the issue with checking to see if the patient¿s stimulation was on or off. The patient¿s stimulation was turned back on for therapeutic use. The symptoms had a sudden onset. The patient was at their health care professional¿s office 9 days prior to report for a programming adjustment and they checked their settings the day prior to report with their patient programmer. The patient had noticed a difference in stimulation on the morning of report. The patient had freezing of their left leg and foot. They had been having problems with the therapy for the last week. They had issues and so they were seen by the manufacturer representative in june and the patient went at the end of (b)(6) to get the settings changed and something ¿wasn¿t right¿ so they went back in the week prior to report for another programming adjustment. The last programming adjustment helped with their prior symptoms ¿for the most part. ¿ the patient felt okay. The stimulation was noted to be back on.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389s-40, lot# v846964, implanted: (b)(6) 2012, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4073049
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« Reply #10 on: February 07, 2015, 09:20:44 AM »

Model Number 37601
Event Type Malfunction
Event Description
It was reported that the patient had the device implanted on (b)(6) 2014 for parkinson¿s and the patient believed the right side was disconnected. The patient had a return of tremors on the left side, he could not walk and kept falling. It was noted that when the patient was taking a shower he had rubbed his head kind of hard and scratched it a little and when he pressed down on his head he could feel tingling in his feet and legs on the left side. This had all begun 3-4 days prior to the date of this report. The patient had called and scheduled an appointment for (b)(6) 2014. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0d7cw, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4). (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4388049
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« Reply #11 on: April 19, 2015, 02:25:05 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had a total of 3 surgeries for the deep brain stimulator (dbs) system. They had done well with the first two surgeries but the third surgery ¿totally did him in. ¿ he had lost muscle strength, had seizures, big falls, and towards the end of his life when he was in the hospital he could not control moving his right foot. The patient was told they had parkinson¿s disease but originally the patient was not diagnosed with that and he just had essential tremors pre-dbs surgeries. No further follow-up is being done on this event as the patient died and it was stated to be unrelated to the device or therapy. The death occurred following the event and therefore, unable to follow-up for patient outcome. Please see manufacturer report #3004209178-2015-04324 for information on the patient's concomitant system.

Manufacturer Narrative
Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator; product id 3387s-40, lot# v556377, implanted: (b)(6) 2011, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 3387s-40, lot# v603771, implanted: (b)(6) 2011, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577570
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« Reply #12 on: September 07, 2015, 06:43:26 AM »

Model Number 37601
Event Date 07/14/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# v561099, implanted: (b)(6) 2011, product type: lead. Product id: 3389s-40, lot# v561099, 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. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

Event Description
The healthcare professional of a clinical study reported that there that the patient experienced capsular activation. The patient was to have the lead moved from subthalamic nucleus (stn) to gip's in order to escape capsular effects in stn. The surgery is being planned for november. The outcome was noted as an ongoing event. The patient experienced cramping pain at voltages around 2 or lower. The patient experienced right wrist and right foot cramping pain with stimulation. The etiology was noted as lead/extension tract. The event was related to the device or therapy and possibly related to the implant procedure. The severity was noted as mild.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5005138
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