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Author Topic: Deep brain stimulator - Electrodes  (Read 77599 times)
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dennis100
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« Reply #150 on: January 26, 2014, 02:04:41 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/11/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no additional info was available, additional info has been requested.

Event Description
Literature: blomstedt p, sandvik u, tisch s. Deep brain stimulation in the posterior subthalamic area in the treatment of essential tremor. Mov disord. Jul 30 2010; 25(10); 1350-1356. Summary: to evaluate the posterior subthalamic area (psa) as a target for deep brain stimulation (dbs) in the treatment of essential tremor (et). Twenty-one pts with et were included in this study from 2004-2007. The group consisted of seven women and 14 men; with a mean age of (b)(6) years. All pts were evaluated before and 1 year after surgery. Dbs in the psa resulted in a marked reduction of tremor. A marked microlesional effect was noticed in 83% of the pts on introduction of the electrode, and due to continued absence of tremor, the stimulation did not need to be started in 35% before discharge from the hospital. No pt had simultaneous stimulation of two ipsilateral electrodes. No severe or permanent complication occurred. No hemorrhages or infections were encountered in this series. Reportable event: four pts experienced mild dysphasia that regressed. These four received an additional ipsilateral electrode (two stn, one vim, and one psa) in the psa due to suspected sub-optimal positioning of the first electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888957
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« Reply #151 on: January 26, 2014, 02:05:59 AM »

Model Number IPGNEURO
Device Problem Positioning Issue
Event Date 05/04/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no additional info was available, additional info has been requested.

Event Description
Literature: capelle hh, blahak c, schrader c, et al. Chronic deep brain stimulation in pts with tardive dystonia without a history of major psychosis. Mov disord. Jul 30 2010; 25(10):1477-1481. Summary: four women with tardive dystonia (secondary to neuroleptic medication) without a history of major psychosis underwent bilateral pallidal dbs in this observational study. Their tardive dystonia occurred more than 6 months after exposure to the neuroleptic medication. All pts had preoperative mr scans; all experienced sustained statistically significant benefit from pallidal dbs and there were no surgically related complications. Reportable event: pt 4 had unilateral stimulation; the electrode on the other side was not activated as it had been misplaced. As unilateral stimulation did not result in sustained improvement over the years, the pt was scheduled for revision of the misplaced electrode and then enrolled in this study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1879532
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« Reply #152 on: January 26, 2014, 02:07:05 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 05/12/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4) - obtundation. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The pt information provided is the average for all the pts. At this time no additional information was available, additional information has been requested.

Event Description
Literature: yoshida f, martinez-torres i, pogosyan a, et al. Value of subthalamic nucleus local field potentials recordings in predicting stimulation parameters for deep brain stimulation in parkinson's disease. J neurol neurosurg psychiatry. Aug 2010; 81(8 ): 885-889. Summary: the authors indicated that online spectral analysis of local field potentials (lfp) recorded from the deep brain stimulation (dbs) electrode may help identify the optimal therapeutic target in the subthalamic nucleus (stn) region for dbs in pts with parkinson's disease. A total of 31 pts participated; all except one pt was implanted bilaterally. The mean age of the participants was 57 years and there were 17 males. Clinical assessment of the efficacy of chronic dbs could not be performed in two of the 31 pts. Reportable event: this report is for one pt in the group of 31 who developed unexplained obtundation postoperatively; the dbs electrodes were therefore removed in the immediate postoperative period.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1884617
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« Reply #153 on: January 26, 2014, 02:08:46 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 03/26/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.

Event Description
Literature: xie j, adamec d, decullier e, et al. Do the effects measured by intraoperative and postoperative stn macrostimulation in parkinson's disease match? j neurol. Sep 2010;257(9):1453-1456. Summary: the aim of our study was to compare the results from 2000 to 2007 obtained by intraoperative and postoperative subthalamic nucleus (stn) macrostimulation in parkinsons' disease (pd). One hundred three pd patients implanted with bilateral stn stimulation were included; the side effects studied were divided into motor contraction, parasthesias and oculomotor sign. Mean age was 61. 2 years and mean disease duration was 15. 6 years. The authors observed small discordance between the intraoperative and postoperative evaluation. Side effects had severe consequences in three patients, in whom the electrodes had to be replaced because of low threshold side effects. Side effects in the other cases were obtained when very high intensity of stimulation was applied (that was not used chronically) or when sub-optimum contacts were used. Reportable event: this report is for patient 2 of 3 that required electrode replacement due to low threshold side effects.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1878190
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« Reply #154 on: January 28, 2014, 09:27:36 AM »

Model Number 3391
Device Problem Bent
Event Date 11/19/2010
Event Type  Malfunction  
Event Description
Upon opening the package in the operating room, it was observed that the area involving the first electrode contact was curved. Another lead was used for the procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1932043
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« Reply #155 on: January 28, 2014, 09:29:22 AM »

Model Number 3389
Device Problem Folded
Event Date 11/22/2010
Event Type  Malfunction  
Event Description
Received info that while unpacking an electrode during surgery the physician saw it was bent inside the package. When he took the electrode out of the package to look more closely he saw the distal end of the electrode was completely bent and could not be used for introduction into the brain. The physician decided to use another electrode. The new one was okay. The pt incurred no injury from this event.

Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937764
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« Reply #156 on: January 28, 2014, 09:30:28 AM »

Model Number LEADMVD
Device Problem No Information
Event Date 11/09/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Received info reporting the electrode for the right hemisphere was misplaced and position of the lead needed to be corrected. Additional info has been requested and if received a follow up report will be sent.

Manufacturer Narrative
(b)(4). This report is being submitted late due to a delay by a manufacturer employee. Training is in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936209
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« Reply #157 on: February 07, 2014, 07:49:14 AM »

Model Number 37601
Event Date 10/21/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4). No device analysis was performed; the device met risk based criteria.

Event Description
It was reported the stimulator and electrodes were infected. It was also noted there were multiple infections after the electrodes and stimulator were implanted. Action taken as a result of the event was noted as invasive intervention. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3578750
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« Reply #158 on: May 11, 2014, 05:58:24 PM »

Model Number 7428
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Manufacturer Narrative
Product id neu_unknown_ext, serial# unknown; product type extension product id neu_ unknown_lead, lot# unknown; product type lead. (b)(4).

Event Description
It was reported the patient experienced less than 50% therapy relief at both their left and right side implants. It was stated impedance testing found impedances greater than 4000 ohms on all electrodes, except electrode 1. It was noted, the patient required hospitalization due to the event and that they were alive with no injury at the time of report. Additional information reported an x-ray had been taken. It was further reported ¿there was a break in the extension near¿ the implantable neurostimulator (ins) and the ¿patient would get a new extension. ¿ further information has been 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=3739661
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« Reply #159 on: May 11, 2014, 08:35:04 PM »

Model Number 37603
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported a deep brain stimulator (dbs) lead was removed for complaints of dysarthria and the magnetic resonance image (mri) found a cystic structure at the electrode tip. It was noted the brain electrode was removed with no adverse sequelae. It was noted the patient¿s speech had improved and their dystonia was still treated by the contralateral electrode.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va00ucg, implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3725131
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« Reply #160 on: May 11, 2014, 08:36:07 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported when the health care professional started to program the patient after their implant, one of the wires did not work so they had to ¿cut it off. ¿ it was noted at the implantable neurostimulator (ins) site there was a wire that stuck out of the patient¿s chest. It was stated it had healed over. It was noted the patient had stimulation on both sides of their body and therefore it was ¿likely that one of the electrodes did not work rather than the entire lead. ¿ additional information received reported the patient¿s surgical incisions were examined and there was no lead protruding. It was stated all incisions were well-healed. It was noted the cause of the issue was not determined. It was stated the patient was re-programmed.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0cnv2, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot # va0bnyf, 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 3389s-40, lot # va0bnyf, implanted: (b)(6) 2013, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736519
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« Reply #161 on: June 07, 2014, 10:48:53 AM »

Model Number 37612
Event Date 02/20/2014
Event Type Injury
Patient Outcome Hospitalization
Manufacturer Narrative
(b)(4).

Event Description
It was reported that there were 1-2 bad electrodes isolated to one side of a bilateral deep brain stimulation (dbs) system. The patient was recharging often and there was high current drain with low impedance. The manufacturer¿s representative had met with the patient the day prior to report to perform impedance testing. Electrode impedances were as follows: c/0 745, c/1 734, c/2 952, c/3 1080, 0/1 44, 0/2 844, 0/3 1125, 1/2 844, 1/3 1125, 2/3 1035. The patient was currently in the hospital for bad gait and speech problems. The patient had been hospitalized for 10 weeks. Extensive reprogramming had been performed by the neurologist and only programming electrodes 0 and 1 seemed to help the patient. The patient was programmed on the shorted contact. It was stated that the patient¿s system was fine prior to hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3830617
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« Reply #162 on: July 04, 2014, 09:12:05 PM »

Model Number 37612
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that there were problems recharging. It was noted that the patient had a hard time charging. It was noted that ever since implant the patient had problems charging. It was noted that the patient usually only got 4 bars and it took a lot of adjusting of her body and she had to ¿prop her boob up. ¿ patient had seen the manufacturing representative last in (b)(6) 2013. It was noted that after 1. 5 hours of charging the patient only got to 50% and the charge would only last about 6 hours. It was noted that the first time the implantable neurostimulator (ins) was too deep and they went back in and moved the ins and had to redo one of the leads in (b)(6) 2013. The recharger would not fully charge the implant. Anomaly appeared to have occurred through product use. There was no indication of patient harm. It was later reported coupling seemed to be the issue with the rechargeable device. It was noted that the patient would recharge for 45 minutes to an hour daily and get up to 50%. It was noted that the recharger seemed to deplete much quicker. Patient had a ¿faulty¿ electrode on the right side and had surgery to replace the lead in (b)(6) 2013. Additional information received reported the patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative. It was noted that the patient had an appointment scheduled for (b)(6) 2014.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot# v944205, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type lead; product id 37751, serial# (b)(4), product type recharger. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3864325
« Last Edit: September 19, 2015, 12:49:38 AM by dennis100 » Logged
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« Reply #163 on: July 04, 2014, 11:53:26 PM »

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 #164 on: August 11, 2014, 01:24:49 AM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that on (b)(4) 2014, the implantable neurostimulator (ins) reached elective replacement indicator (eri). The reporter stated that premature battery life was suspected. It was noted there was an eri notification for six days. It was further noted that impedance testing and reprogramming was done. The reporter stated the ins was replaced on (b)(6) 2014. It was noted the patient was programmed with the following settings ¿1-, 9-/ p 330 and r 150. ¿ it was noted that there were no patient symptoms or complications associated with this event. It was further noted the patient status at the time of this report was alive with no injury. Additional information received reported the ins was explanted on (b)(6) 2014. The reporter stated that no longevity calculation was done. It was further noted that some electrodes on the right hemisphere were out of range. It was noted that c and 11 had an impedance of 2456 ohms. 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=3960852
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« Reply #165 on: November 08, 2014, 08:41:28 AM »

Model Number NEU_INS_STIMULATOR
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

Event Description
It was reported there was an impedance issue of unknown value on electrodes 9 and 11. It was noted the patient had their battery changed in (b)(6) and two electrodes shorted after the case. Since then the doctor couldn¿t program around the shorts and had turned the deep brain stimulator (dbs) off. The patient status at the time of report was alive with no injury and they had a less than 50% therapy relief. The dbs was off so the patient couldn¿t function. 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=4132520
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« Reply #166 on: January 10, 2015, 12:39:37 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. 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. Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported there was a shocking or jolting sensation. They had shocking in the pocket and down the arm. It was unknown how long it had occurred and it was unknown if there were any falls or trauma associated with the change. There was high impedance >4,000 ohms on monopolar configuration. Both of the left and right monopolars were out of range but the right was much higher; the range was 16,000-20,000 ohms. The left side ranged from 3,300-5,600 ohms. The patient had already been referred to a neurosurgeon for possible revision. Additional information received reported they were going to do intraoperative troubleshooting because of a suspected issue with the electrodes. They would also check the extensions. The surgical procedure would happen on (b)(6) 2014. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4366231
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« Reply #167 on: January 10, 2015, 01:35:25 AM »

Model Number 7428
Event Date 11/01/2014
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that interrogation of the patient¿s implantable neurostimulator (ins) with a physician programmer ¿showed a charge density warning although the stimulation parameters were far beyond the warning limit. ¿ it was stated there were ¿stimulation/therapy issues¿ with ¿less than 50% therapy relief¿ at an unknown location. Ongoing troubleshooting was being performed due to the event at the time of initial report. The patient was alive with no injury at the time of report. It was noted the patient¿s right electrode was positioned in their subthalamic nucleus (stn). Impedance testing found that unipolar electrodes 6 and 7 (on the patient¿s left half) had impedances ¿>4000¿ ohms when tested at 3 volts. Interrogation records indicated the patient¿s right half therapeutic impedance was ¿>4000¿ ohms and the left half returned a ¿???¿ impedance value. It was noted the patient¿s left half was ¿not included in the therapy¿ and was ¿set to 0 volts¿ while the patient¿s right half was set to 1 volt. The patient was reportedly ¿ok¿ 18 days after initial report, but their ¿therapy was not 100% effective. ¿ the patient was noted to be scheduled to receive a ¿new ins¿ and undergo an additional impedance test and troubleshooting during an appointment scheduled for 2015-(b)(6). Additional information has been 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=4362417
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« Reply #168 on: January 10, 2015, 11:25:26 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that high, but not out of range impedances were measured. The manufacturing representative was contacted on the day of this report by the patient¿s healthcare professional (hcp) because, the patient programmer was displaying end of service (eos). The battery depletion was considered premature. The manufacturing representative met with the patient on the day of this report and ran impedances. The only electrodes that seemed out of ordinary were zero and six. All pairs with electrode zero on the left lead were between 13,000-15,000 ohms and all pairs with electrode six on the right lead were between 6,000-7,000. The patient¿s left subthalamic nucleus was programmed to 0-, 3+ and the right subthalamic nucleus was programmed to 4-, 7+. The manufacturing representative did not change the programming since the patient did not have any tremors and they were receiving good therapy. The patient¿s implant incision was also infected due to the ruptured breast implant. The patient¿s hcp was treating and monitoring the infection. 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.

Manufacturer Narrative
Product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4295123
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« Reply #169 on: February 07, 2015, 06:37:04 AM »

Model Number 37601
Event Date 01/09/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id neu_unknown_lead, lot# unknown, product type; lead. (b)(4).

Event Description
It was reported the lead was damaged during implant. Electrode three on the distal end of the lead was stretched, frayed, and cut off of the end during the procedure and would not insert into the extension properly. The lead was damaged when the healthcare professional (hcp) used forceps to pull the boot off. The lead was being revised because the hcp felt the lead was placed slightly lateral. The lead was implanted and impedances were measured. Impedances of electrodes one and two were measured to be normal. Electrodes one and two were the electrodes that showed the most efficacy during testing. On 2015-01-10, the impedances were checked again and they were normal. The patient was receiving effective therapy and tremor control.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4465068
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« Reply #170 on: March 07, 2015, 04:37:46 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Age at time of event: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id 3389s, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_ext, lot# unknown, product type: extension; product id 3389s, lot# unknown, product type: lead. (b)(4).

Event Description
Matzke, c. , hammer, n. , weise, d. , lindner, d. , fritzsch, d. , classen, j. , melxensberger, j. , winkler, d. Deep brain stimulation using simultaneous stereotactic electrode placement : an alternative to conventional functional stereotaxy? der nervenarzt. 2014. Doi: 10. 1007/s00115-014-4214-4. Summary: the subthalamic nucleus region (stn) is undoubtedly one of the most preferred target regions for the stimulative treatment of idiopathic parkinson¿s disease (ipd). In addition to pre-operative imaging and secondary image processing, actual electrode placement is the subject of present discussions. Here, the stereotactic principle is the key to success. An entirely new approach and, in its importance not previously appreciated one, is that of an individualized and semi-automated procedure for the stereotactic care of patients. The system presented in this study offers the opportunity for the first time to discuss an individualized procedure in the context of functional stereotaxy. The basis and at the same time limitation of the conventional stereotactic systems used hitherto is their rigid structure in terms of inflexible ring systems fixed to the patients¿ head. Reported events: 1. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease had an infection in the generator pocket. It was noted that this complication was conservatively treated. 2. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease had an infection in a bone anchor placed in the anterior area. It was noted that this complication was conservatively treated. 3. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced an electrode break. This defect reportedly led to electrifying sensations in the head region and a need for revision. 4. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced an infection in the temporarily externalized electrode cable during the test phase. 5. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced a ballooning of the generator pocket requiring revision as a result of a collection of cerebral spinal fluid (csf). The source literature included the following device specifics: quadripolar platinum/iridium electrode model 3398 and activa implantable neurostimulator unknown model number 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=4551755
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dennis100
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« Reply #171 on: July 15, 2015, 11:21:27 PM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2011 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0313908v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0313844v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension. (b)(4).

Event Description
It was reported that during an implantable neurostimulator (ins) replacement surgery, the healthcare professional (hcp) noticed there was damage to the left extension. There was a severed connection in the area near the ins and the ins was twisted in the pocket. The right ins was replaced since the ins was at end of service (eos). The left ins was not replaced because, the patient was not consented for an extension replacement. The patient was not having any therapy issues related to the left ins. Prior to surgery, the manufacturing representative did not do telemetry with the ins. After they surgery, the left ins was interrogated and a short was noticed on electrodes 0 and 3. Impedances of less than 50 ohms were measured on 0-3. The cause of the event was not determined. The left ins was turned off until the revision and the patient was experiencing symptoms on their right side. Another revision was planned on the left side to replace the extension and ins.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4868358
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« Reply #172 on: July 15, 2015, 11:22:51 PM »

Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient experienced ¿stimulation in the wrong location¿ and a ¿change in gait¿ involving their ¿left side implant. ¿ it was further reported the patient ¿had new-onset gait freezing with stimulation. ¿ a post-operative ct scan was performed and found the patient¿s ¿lead had deviated when it left the insertion cannula (20mm above the target)¿ and that ¿this resulted in the electrodes being positioned in the wrong brain structure (the posterior subthalamic area (psa), not the subthalamic nucleus (stn) as planned). ¿ it was noted the ¿left lead deviated¿ and that ¿both leads were revised as both ended up medial to the initial plan. ¿ it was additionally noted there was a ¿bent lead. ¿ the patient¿s leads were explanted and replaced as a result of the event. The patient was ¿receiving effective therapy with no gait freezing¿ following their bilateral lead revision. Additional information was requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4850234
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« Reply #173 on: September 07, 2015, 06:57:39 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/23/2015
Event Type Injury
Manufacturer Narrative
Concomitant product: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
The health care provider (hcp) reported via the company representative (rep) that on (b)(6) 2015 the lead, implanted in the occipital right, was removed in emergency after "the externalization of the electrode under the skin. " in absence of the electrode, the pain felt by the patient was not correctly/properly relieved. The issue was resolved at the time of the report. 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=5021186
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« Reply #174 on: September 07, 2015, 06:58:28 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/12/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, explanted: (b)(6) 2015, product type: lead. Product id: 3389-40, lot# 0209659132, implanted: (b)(6) 2015, explanted: (b)(6)2015, product type: lead. (b)(4). (b)(6).

Event Description
It was reported the patient experienced a return of rigidity symptoms after falling down. Impedance testing was performed and found ¿high impedances on his right brain. ¿ the patient¿s physician decided to replace their lead as a result of the event. Upon connecting a replacement lead with the patient¿s original extension, the physician experienced a ¿problem when he tightened the screw; he found that two electrodes were broken. ¿ the physician then stopped and removed the replacement lead. The patient¿s physician ¿planned to revise the case again¿ the month after initial report. There was ¿no¿ patient injury or death from the event. The patient was being treated with medication at the time of report and was awaiting recovery to undergo an additional revision procedure. Additional information was requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4964692
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« Reply #175 on: September 07, 2015, 06:59:15 AM »

Model Number 37602
Event Date 07/17/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# v259066, implanted: (b)(6)2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6)2009, product type: extension. Product id: 37602, 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: 3389s-40, lot# v032588, implanted: (b)(6)2007, product type: lead. (b)(4).

Event Description
A consumer reported that when they were in recovery after the implantable neurostimulator (ins) was replaced, a health care provider (hcp) mentioned that only one electrode was working. Out of surgery, all electrodes were working and the leads were working when the patient left. Since the ins replacement, the patient had diplopia in their left eye. There were no falls or accidents and the patient had an appointment scheduled with an ophthalmologist. The patient's indication for use is parkinson's dual 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=5003946
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« Reply #176 on: September 19, 2015, 02:55:43 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/29/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3387-28, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4). Device analysis for extension nkn101030v revealed the distal end conductor was broken up to transition point.

Event Description
The company representative (rep) reported that a malfunction occurred. During surgery all connections were made for the lead, adaptor, and stimulator. Then the impedances were checked prior to closing the incision, however, all measurements involving electrode 2 (c2, 12, 23) showed a value in excess of 40,000 ohms. The adaptor connection was disconnected and reconnected four times or so and wiping the connection, however, the situation of excess of 40,000 ohms did not change. Subsequently a twist-lock cable was used for checking the impedances of the lead alone; no abnormality was detected with the lead impedance. A new adaptor was unpacked, which recovered to normal impedance value. It was noted that considering the fact that all measurements related to electrode 2 were abnormal, there might be a fracture in electrode 2. It was also stated that electrode 2 was completely bad, so perhaps it was disconnected. An investigation was requested. 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=5024798
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