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Author Topic: Deep brain stimulator - Arms  (Read 52320 times)
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dennis100
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« Reply #90 on: April 10, 2014, 09:29:38 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

Event Description
It was reported that after a replacement the patient had hallucinations, line of sight blurring, and limb stiffness during the night. The patient went for programming in (b)(6) 2013, but the effect did not improve. The patient called into consult how to deal with it. The following day it was reported that the patient still had hallucinations and limb stiffness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3662942
« Last Edit: February 07, 2015, 08:58:32 AM by dennis100 » Logged
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« Reply #91 on: May 11, 2014, 08:44:53 PM »

Model Number 37602
Event Type Injury Patient Outcome Other
Event Description
It was reported there was a shocking or jolting sensation. It was noted the patient felt ¿paralyzed in their leg¿ the day prior to report. It was noted they felt ¿paralyzed in their arm and shocking¿ since the implant. It was noted the patient had fallen on (b)(6) 2013. It was stated they had fallen and broken their hip. It was noted the patient had not done well since the fall. It was noted the paralyzed feeling in their leg had not gone away. It was stated their arm would go paralyzed for 8 seconds and then it would stop. It was noted the patient had seen their doctor the week prior to report and no adjustments or changes were made to the dbs settings. It was noted they had requested to not have the dbs raised because it would cause a shocking sensation and it would paralyze them.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# l54554, implanted: (b)(6) 1998, product type: lead. Product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1998, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734588
« Last Edit: February 07, 2015, 08:59:08 AM by dennis100 » Logged
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« Reply #92 on: May 11, 2014, 10:11:47 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

Event Description
It was reported the patient¿s deep brain stimulation (dbs) device was implanted (b)(6) of 2012 and they could never program it. The leads were implanted and ten days later they put the battery pack in and they waited another ten days before they turned it on to program it. The patient¿s healthcare provider (hcp) could not figure out why on the lowest setting the patient could not talk, his left arm would come up to his chest when he would walk and his right shoulder kept twitching or spasming. From the time it was implanted the device did not really function for the patient; every time they turned it on and gave him medications to try to control the dyskinesia it did not work and this was after a year of oral medication. It was noted the patient was dyskinetic the entire time the device was implanted. It stayed in for about a year until they could not figure out why or what was going on. Every time the patient turned it on ¿patient shoulder would, he was falling three times a day. ¿ the patient fell in his house and broke his ribs the last saturday in (b)(6) 2012. The patient¿s dbs device was turned off and he was better but he still had some of the dyskinesia and had tremendous headaches. In (b)(6) of 2013, the patient had his device removed as he could not handle it anymore. The patient was sure there was a short circuit or something like that which caused the dyskinesia. It was reported the patient thought the leads down in the globus thalamus would not do that, he understood it may affect his speech, but not the rest of it. It was reported the device was leading to such headaches and such problems; he had a big bony growth behind his ear in his skull which was occurring during the entire time the device was implanted. After the device was removed those symptoms went away. Additional information received two weeks later reported somewhere around the second week of (b)(6) 2012 the patient was in severe dyskinesia one night and he could not turn it off. He did not know what was going on and he finally got in touch with a manufacturer representative from (b)(4) who walked his wife through turning his device off. It was also reported the patient¿s unit did not come out easily, the leads and all that stuff did not come out easily. 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=3745721
« Last Edit: February 07, 2015, 09:00:16 AM by dennis100 » Logged
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« Reply #93 on: June 07, 2014, 09:23:29 AM »

Model Number 37603
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported that the patient presented in the last two weeks with enormous edema around one of his two leads. The patient also had some hemorrhage around the contact zone. The working diagnosis was an indolent infection, but the neuro radiologist felt the case looked more like a reaction to the lead, possibly ¿thermal¿ injury. The physician thought the lead may have possibly contributed to the infection. The lead was explanted and would be replaced in the future. Three days later it was reported that the patient was in the hospital because the infection was thought to be a concern. The infection was thought to be down the length of the lead and it was being cultured. The patient reported that last week he went through a metal detector at a courthouse with his system on and since then had been having trouble with his right side system. The patient¿s left arm was shaking badly. The implantable neurostimulator (ins) was not interrogated after the patient went through the metal detector because the lead was removed before they were aware of the issue. It was noted that no shock was mentioned when going through the system. The patient was told by the courthouse employee that the system was totally fine for him to go through after a bypass was requested because it was a ¿new¿ system. The issues occurred on (b)(6) 2014 and the patient went to the hospital the day after. The reporter noted that the therapy had been a huge improvement for the patient. Two days later it was reported that the doctor was concerned a new type of metal detector could possibly create adverse events with patients. The doctor was not sure if the patient¿s problems were caused by the metal detector, but wanted to consider all possible explanations. The patient reported feeling ¿different¿ a couple of days after (b)(6) 2014. A scan showed unilateral edema and fluid accumulation around the lead. The lead culture came back negative for an infection. The doctor was thus seeking alternate explanations and a ¿neuroradiologist¿ told him that it may be a thermal lesion. The doctor speculated and wondered if passing through a security metal detector could cause lesions. The patient was doing very well after explant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3835878
« Last Edit: February 07, 2015, 09:00:49 AM by dennis100 » Logged
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« Reply #94 on: June 07, 2014, 09:24:34 AM »

Model Number 37612
Event Date 05/05/2014
Event Type Injury Patient Outcome Other
Event Description
It was reported there was high impedance of >40,000. It was noted it was unknown what caused the high impedance. It was stated the patient was reprogrammed as a result of the event. It was noted the issue was not resolved. It was stated the patient status at the time of report was alive with no injury. It was noted the patient had seizures. It was noted they tried to reprogram around a lead electrode with high impedance and during the reprogramming the patient had experienced a seizure. It was noted the devices were implanted in an off label manner and use. It was noted the location of the issue was at the left side implant. It was further reported the high impedance did not resolve. It was clarified that this was not a deep brain stimulator (dbs) patient and it was a research patient who had paddle leads placed on their brain to provide epidural cortical stimulation to help treat depression. It was noted it was an off-label research. It was stated the patient was doing fine at the time of report and they left the hospital a short time after the seizure occurred. It was noted they returned to the hospital the next day and the doctor had turned their devices back on. Additional information received reported the patient¿s amplitude on (b)(6) 2014 was increased for a therapeutic delivery of approximately 13 uamps. It was stated the day prior to report the patient¿s mood was 85% of goal. It was noted they had no plans to change anything as the patient¿s mood particularly had turned around for the previous 2 days. It was stated that was until the doctor had seen 1 contact (11) in the right lateral paddle that consistently showed >40,000 for resistance which suggested an open contact. It was noted contact 11 was turned off. It was noted the configuration was changed in the paddle and the therapeutic delivery dropped from approximately 13 to 6. It was noted within minutes the patient began to have facial twitching and clonic movements in their upper extremities. It was noted the patient appeared to have a partial seizure in the doctor¿s office that had stopped within seconds of turning off the right system. It was stated both ins¿ were turned off and they had the patient transported to the emergency department. It was noted they appeared to have partial weakness in their left upper extremity and a facial droop postictal (todd¿s paralysis) that had resolved completely within minutes. It was stated by the time the patient was at the emergency department, they were completely asymptomatic. It was noted the head computed tomography scan (ct) was negative and their basic metabolic panel was within normal limits. It was stated the patient was discharged home. It was noted the patient was seen on the day of report and their mood was pretty good and they didn¿t have the lethargy that the patient had dealt with in the mornings for the past few months prior to report. It was noted the patient seemed to tolerate the current settings. It was stated the patient would be seen one week following report. It was noted the patient had arrived on the day of report without any sequelae.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3835894
« Last Edit: February 07, 2015, 09:01:19 AM by dennis100 » Logged
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« Reply #95 on: July 04, 2014, 09:07:36 PM »

Model Number 37601
Event Date 04/29/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
T was reported there were low impedances of 33 ohms on electrodes 0 and 1. The patient complained of tingling sensation down their right arm at different times. The tingling occurred sporadically and could be reproduced by palpating their chest where the stimulator was implanted. The stimulator was replaced. During the procedure it was clear there was fluid in the head portion of the stimulator. Additional information reported the patient was receiving therapy and had not reported any tingling sensation. It was reported the stimulator had been nearing end of life. It was also noted there was fluid around the pocket of the stimulator. The patient had been experiencing a shocking sensation when touching around the stimulator. The event was noted as resolved without sequelae and not related to the device or therapy and unlikely related to the implant procedure.

Manufacturer Narrative
Concomitant products: 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 3387s-40, lot # va0buyn, implanted: (b)(6) 2013, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v553425, implanted: (b)(6) 2010, product type lead. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3869958
« Last Edit: February 07, 2015, 09:01:45 AM by dennis100 » Logged
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« Reply #96 on: July 04, 2014, 11:51:55 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
« Last Edit: February 07, 2015, 09:02:33 AM by dennis100 » Logged
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« Reply #97 on: August 10, 2014, 06:13:16 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3922599
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« Reply #98 on: September 06, 2014, 12:40:01 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative
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: 3387, lot# unknown, product type: lead. (b)(4).

Event Description
Sriram, a. , foote, k. D. , oyama, g. , kwak, j. , zeilman, p. R. , okun, m. S. Brittle dyskinesia following stn but not gpi deep brain stimulation. Tremor and other hyperkinetic movements (new york, n. Y. ). 2014;4:242. Doi: 10. 7916/d8ks6ppr summary: the aim was to describe the prevalence and characteristics of difficult to manage dyskinesia associated with subthalamic nucleus (stn) deep brain stimulation (dbs). A small subset of stn dbs patients experience troublesome dyskinesia despite optimal programming and medication adjustments. This group of patients has been referred to by some practitioners as brittle stn dbs-induced dyskinesia, drawing on comparisons with brittle diabetics experiencing severe blood sugar regulation issues and on a single description by mclellan in 1982. We sought to describe, and also to investigate how often the ¿¿brittle¿¿ phenomenon occurs in a relatively large dbs practice. An institutional review board-approved patient database was reviewed, and all stn and globus pallidus internus (gpi) dbs patients who had surgery at the university of florida from july 2002 to july 2012 were extracted for analysis. There were 179 total stn dbs patients and, of those, four stn dbs (2. 2%) cases were identified as having dyskinesia that could not be managed without the induction of an ¿¿off state,¿¿ or by the precipitation of a severe dyskinesia despite vigorous stimulation and medication adjustments. Of 75 gpi dbs cases reviewed, none (0%) was identified as having brittle dyskinesia. One stn dbs patient was successfully rescued by bilateral gpi dbs. Understanding the potential risk factors for postoperative troublesome and brittle dyskinesia may have an impact on the initial surgical target selection (stn vs. Gpi) in dbs therapy. Rescue gpi dbs therapy may be a viable treatment option, though more cases will be required to verify this observation. Reported event: one (b)(6) male patient experienced right upper extremity and right lower extremity dyskinesia at both the 1 and the 2 contacts on the deep brain stimulation (dbs) lead following left-sided subthalamic nucleus (stn) dbs implant. It was noted that the 1 and 2 dbs lead contacts corresponded to the best therapeutic benefit during programming sessions. The reporter stated that multiple programming strategies were employed, including attempts at slow stimulation titrations, and the use of a more dorsal dbs contact site. Reportedly, the dyskinesia only abated when the dbs was turned off. It was noted that attempts were made to commensurately decrease carbidopa/levodopa dosage in combination with stimulation changes, but this reportedly worsened the patient¿s off state, though at low medication dosages dyskinesia abated. The reporter stated that the patient experienced a similar clinical scenario when the right stn dbs was added. Reportedly, at settings that improved his freezing of gait, the patient had bothersome left lower extremity dyskinesia. It was noted that many other attempted settings failed to capture his gait freezing and the off symptoms. The reporter stated that the patient underwent rescue bilateral staged globus pallidus internus (gpi) dbs in a single operative sitting, and following programming, the dyskinesia completely abated, and the patient was able to maintain a smooth on medication state. The source literature included the following device specifics: lead model 3387 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=3976613
« Last Edit: February 07, 2015, 09:02:58 AM by dennis100 » Logged
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« Reply #99 on: September 06, 2014, 12:40:43 AM »

Model Number 7426
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported a couple of months prior to report the patient started to have a shocking sensation down their right side and right arm. The patient had high impedances and they could not isolate it to anything. Both of the patient¿s batteries were near depletion so they replaced both devices in may and everything cleared up, including impedances.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3999542
« Last Edit: February 07, 2015, 09:03:23 AM by dennis100 » Logged
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« Reply #100 on: September 06, 2014, 12:41:30 AM »

Model Number NEU_UNKNOWN_LEAD
Event Date 06/04/2014
Event Type Injury
Patient Outcome Hospitalization,Life Threatening,Required Intervention
Manufacturer Narrative
Product id: neu_unknown_ext, serial# unknown, implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
It was reported that the adverse event was right corona radiate infarct. It was noted that at the time of report it was unknown if the patient planned to complete deep brain stimulation (dbs) procedure. It was noted that the outcome was resolved without sequelae on (b)(6) 2014. It was noted that interventions included medical or non-surgical intervention including warfarin and phenylephrine infusion on (b)(6) 2014. It was noted that diagnostic methods included a nih stroke scale evaluation with a score of 5 and an mri without contrast showing no indications of stroke or hemorrhage on (b)(6) 2014. It was noted that and mri with contrast showed right corona radiate infarct a day later. It was noted that the etiology included surgery/anesthesia. It was noted that the event was not related to the device or therapy and was related to the implant procedure. It was noted that during lead placement the patient became sleepy, dysarthric with left facial droop and left upper extremity weakness. It was noted that the severity was severe. It was noted that the event resulted in in-patient hospitalization. It was noted that the event was a life threatening situation. 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=3976485
« Last Edit: February 07, 2015, 09:03:45 AM by dennis100 » Logged
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« Reply #101 on: September 06, 2014, 01:43:00 AM »

Model Number 7426
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported a couple of months prior to report the patient started to have a shocking sensation down their right side and right arm. The patient had high impedances and they could not isolate it to anything. Both of the patient¿s batteries were near depletion so they replaced both devices in may and everything cleared up, including impedances.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3999542
« Last Edit: February 07, 2015, 09:04:05 AM by dennis100 » Logged
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« Reply #102 on: September 06, 2014, 01:43:41 AM »

Model Number 37601
Event Type Injury
Patient Outcome Hospitalization
Event Description
Additional information received reported that there was a 50% or greater symptom reduction. The cause of the event was not determined, but it was not device related and did not require reprogramming. The patient was hospitalized due to disorientation and confusion. The patient was in a group home setting as well. No interventions or action were taken and the patient outcome was unknown.

Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389s-40, lot# v333543, implanted: (b)(6) 2009, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389-40, lot# l75963, implanted: (b)(6) 2000, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 7495-25, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. (b)(4).

Event Description
An emergency room (er) doctor reported that the patient had a sudden loss of therapeutic effect as it happened within the past one or two days. The patient presented to the er on the day of the report with decreased alertness and tonic-clonic tremors in his arms and legs. The symptoms were worse on the left side than the right. The patient¿s wife felt like this was a return to baseline symptoms for him. It was requested that a manufacturer representative come check the patient¿s system as there was no patient programmer available. No patient intervention or outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3999664
« Last Edit: February 07, 2015, 09:04:30 AM by dennis100 » Logged
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« Reply #103 on: September 06, 2014, 06:15:17 AM »

Model Number 37612
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37092, lot# 337540001, implanted: (b)(6) 2012, product type: accessory; product id 3 708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead; product id 37651, serial# (b)(4), product type: recharger; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported the patient recently had battery replacement surgery and the first implantable neurostimulator (ins) had lasted 23 months. The patient had been implanted now with a rechargeable ins and they experienced some problems. The new device was ¿cross-wired¿ when it was implanted but it was ¿not that big of a deal. ¿ the battery was implanted backwards. It was stated the battery was flipped and the problem was resolved with programming. The patient felt like the ins was going on and off and they felt an electrical charge down their right side fairly often and they were not talking as well or doing as well as with the previous deep brain stimulator (dbs). The patient was never able to charge up passed 75%. They suspected there was a problem with the battery. When the patient charged the day prior to report their ins battery level started at 50% and they had all 8 coupling bars. The patient tried to recharge the ins for ¿half a day¿ and they never got passed 75%. The patient did monitor while they recharged and would reposition the antenna to get 8 coupling bars. There was nothing ¿medically wrong¿ with the patient. It was further reported it ¿sounded¿ like the surgeon switched the left brain extension and the right brain extension during the battery exchange so the patient was doing poorly because the settings for the left were in their right brain and vice versa. The patient¿s doctor had switched it back during reprogramming and they felt much better. The patient was scheduled to go back to see their neurologist soon. Additional information received reported since the change out they had times when they would get an overstimulation feeling that was not associated with movement. They would also get it when they recharged, typically 20 minutes in. However, it was noted to have happened immediately on the day of report when they were in the office with the manufacturer representative and it gave them a dyskinetic feeling. They would get the same overstimulation feeling with telemetry. The impedance measurements were normal. The patient was too sore for palpation. It was further reported the patient was a high energy user. They had recharged the implant for 8 hours and could not get to 100%. It was further reported the patient tried to charge the ins the night prior to report and it overstimulated her. It was noted the ¿whole right side was jumping. ¿ they felt like the stimulation was going on and off by itself. The current would go down their right side and it was the same feeling as when their doctor would program her. They were reprogrammed the week prior to report by their doctor and it worked for a little while. It was stated the non-rechargeable device had worked good but the rechargeable one had not worked well since the implant. It was not a programming issue but the battery did not work correctly. The device would overstimulate the patient and their arm would jump. Additional information received reported the patient had dyskinesia when they would recharge. The patient was given an expanded ability to reduce their stimulation while they recharged so they could charge without major dyskinesia. This allowed the patient to finally reach 100%. There was also a complaint about the patient¿s voice but it seemed the same on and off so they guessed it might be just the progression of the disease. The patient agreed that they were doing very well with their therapy and they were charging fine at the time of report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4030799
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« Reply #104 on: October 12, 2014, 04:17:17 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that the patient experienced a shocking or jolting sensation. After an upgrade to a rechargeable implantable neurostimulator (ins), the patient experienced shocking and jolting down their right arm. Impedance testing was performed and all measurements were within normal ranges. It was noted that the patient required fairly high amplitudes to control essential tremor. Amplitude was decreased, which resulted in a ¿less extreme¿ shock. The patient was programmed in bipolar mode in both hemispheres. The ins was implanted in the left pectoral region. The patient reported the shocking sensation was similar to what was felt when stimulation was being switched from off to on. Postural changes did not seem to cause or alleviate the shocking. The patient was admitted to the hospital. Stimulation to the left brain was decreased from 5. 4 v to 4. 0 v, after which the patient no longer experienced the shocking sensation, but the patient then experienced compromised therapy to their right side. Impedances were checked again and were still within normal ranges. Impedances were as follows: c<(>&<)>0 868, c<(>&<)>1 820, c<(>&<)>2 883, c<(>&<)>3 498, 0 <(>&<)>1 1168, 0<(>&<)>2 1353, 0<(>&<)>3 1097, 1<(>&<)>2 1168, 1<(>&<)>3 1016, 2<(>&<)>3 1022, c<(>&<)>4 846, c<(>&<)>5 698, c <(>&<)>6 692, c<(>&<)>7 736, 4<(>&<)>5 907, 4<(>&<)>6 1068, 4<(>&<)>7 1168, 5<(>&<)>6 768, 5<(>&<)>7 968, 6<(>&<)>7 816. Therapy impedances were also measured and within normal ranges. Exploratory surgery was performed on (b)(6) 2014. Impedances were again tested on the left brain lead and both extensions and all impedances were within normal range. The ins and pocket adaptor were explanted and replaced. Since the replacement, the patient had not experienced any further shocks. The patient recovered fully.

Manufacturer Narrative
Concomitant products: product id 64002, product type adapter. (b)(4). 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=4103211
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« Reply #105 on: October 13, 2014, 12:22:35 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078338
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« Reply #106 on: October 13, 2014, 02:06:17 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078222
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« Reply #107 on: October 13, 2014, 02:07:04 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient was in a car accident 5-6 weeks prior to report. For the following 2 weeks after the accident, the patient felt tingles in their body, but the therapy was still good. Then after the 2 weeks, the patient had a shock in their right arm and on the right side of their body and the therapy was lost. The programming neurologist had scheduled an exploratory surgery on the day of report because of lowered impedances and the implantable neurostimulator (ins) went dead. Their tremor came back everywhere. The left therapy impedance was 82 ohms with a ¿high current¿ and the right therapy impedance was 1,984 ohms. It was noted there could still be an issue with the left lead after they closed up just based on the patterning of impedances. Additional information reported impedances were taken at default and the patient was feeling stimulation when they did so they did not increase to 1. 5v. An ins longevity calculation was performed and it showed 15 months. The patient was getting better therapy than ever, even before the accident. Further follow-up is being conducted to obtain more information. Left lead electrode impedance: c0 2922, c1 1402, c2 922, c3 844, 01 2899, 02 3194, 03 3112, 12 1548, 13 1517, 23 210; right lead electrode impedance: c8 2879, c9 3943, c10 2320, c11 1425, 89 5835, 810 4857, 811 3849, 910 5441 911 4593, 10 11 2883.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v407602, implanted: (b)(6) 2010, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4072456
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« Reply #108 on: November 07, 2014, 11:07:06 PM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient was seen last in (b)(6) 2013 and they would be seen by their clinician 2 days following report. The electrode impedances were measured and they were all fine and normal. The ins that was implanted on their right chest had a slight tingling sensation to their arm. Additional information received reported the patient still had concerns with their device or therapy, but they were working with their manufacturer representative or doctor. It was stated they had an appointment scheduled for (b)(6) 2014. Additional information received reported there was a 50% or greater symptom reduction. It was later reported that the patient was scheduled to have both of the implantable neurostimulators (inss) replaced on (b)(6) 2014. The patient was seen on (b)(6) 2014 for adjustment and reprogramming. The right stimulator was interrogated and the patient had mild paresthesia in the left arm. Right side settings were at 4. 1v, 90usec, 185hz, and 3+2- with minimal tremor in the left arm. The patient was seen on (b)(6) 2014 and there was no evidence of discontinuity of the leads of extensions. The patient¿s was also seen on (b)(6) 2014 for a device adjustment, weakness and gait difficulty. The weakness onset had been gradual and occurring in a persistent pattern for 4 months prior to the appointment, but had first occurred more than 40 years of age. Weakness had been characterized as difficulty arising from a chair, climbing stairs, walking, and increased weakness following exertion and at the end of the day. Weakness was located in the legs and on the right side only. It was associated with numbness. Patient had falls, difficulty ambulating and a gait disturbance. Onset for gait issues had been gradual starting about 8 months prior to the appointment, but was worsening. The patient had slow speech, romberg sign positive, impaired toes, and was tandem walking impaired which were noted during a physical exam. The patient was still experiencing frequent shocks with the battery with fluctuating responses of the battery. The patient was going to be scheduled for a neurosurgery appointment for a battery change. For numbness and tingling, low back pain and right leg weakness an electromyography (emg) and computerized tomography (ct) were going to be performed. Reference manufacturer¿s report number: 3004209178-2014-12463 for the patient¿s other implanted system and the shocking issues that were isolated to that system.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v368056, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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« Reply #109 on: November 07, 2014, 11:33:18 PM »

Model Number 37601
Event Date 10/14/2014
Event Type Injury
Event Description
It was reported that the patient experienced weakness in their arm while waiting to be discharged after an implantable neurostimulator (ins) replacement surgery. The patient was admitted to the hospital for further testing and was to be examined for a potential stroke. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Product id 37085-60, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v383702, implanted: 2010 (b)(6); product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4215823
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« Reply #110 on: November 07, 2014, 11:34:38 PM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had the second surgery for deep brain stimulator. The left side neck was hurting but this was due to head resting on neck before having the implantable neurostimulator (ins) put in. Patient¿s left side head was leaning on his neck and was going down. It was noted that the right side was bended. The ins would be turned on friday following the date of this report to see if the patient would be able to sit up straight and walk upright. The ins was not on yet. It was later reported that the patient¿s neck was still tipping to the side when he walked. Patient was implanted with deep brain stimulator first on the right and then on the left. Patient was still in pain and had numbness in his fingers and had since right after the implant surgery. Neck was still tipping to the side and it causes the patient depression. Patient leaned to the left. Inquired when the patient would begin to see results regarding his neck and ribs. Since implant the patient¿s neck had gone down and he was in a lot of pain. Patient had a follow-up appointment scheduled for the day following (b)(6) 2014. Since patient¿s last surgery on (b)(6) 2014 he had terrible neck pain. The patient¿s neck was hanging to the left and pain was going from the back of the neck down his back. It was noted that prior to this implant the patient was getting botox shots in his neck every 3 months which helped with the pain and he was able to keep his head up. Patient had two devices implanted on (b)(6) 2013 and (b)(6) 2014, the issues with the neck had been since the (b)(6) 2014 implant. Since implant the patient¿s symptoms had shown no improvement. Patient¿s body was not agreeing with the implantable neurostimulators (inss) and patient wanted to receive the operation to cut some of the muscle so it had expansion. It was noted that at the time of this report and before implant the patient¿s head touched his shoulder and when he lifted it up it pulled back down and he had bad pain in his shoulder blades. The patient walked a little slanted and half of his ribs were like round. Prior to implant the patient had had issues with his neck and that was the reason for getting the deep brain stimulator. It was noted that ¿all this time¿ his head was still the same. The deep brain stimulator was bothering him, he did not go outside or do anything. On (b)(6) 2014 the patient had an appointment with a healthcare professional who cuts muscles to give the head an opportunity to be straight. Patient wanted the device taken out but was told it was not going to be taken out. It was noted that every 4 years they had to cut him to change the battery and the patient had two devices and the patient did not understand why they would not do it. Patient felt the lead coming up from his neck to his skull. The patient still walked lopsided and head was still down and the patient still experienced the same symptoms he had prior to the implant. It was noted that the left side was real hard when he touched it coming down his neck and into his skull, it hurt a lot. The left side arm, shoulder and all the way down to his fingers was painful and went to sleep and the patient had to rub icy hot on it. This had been occurring for a couple of months prior to the date of this report. It felt tight and like blood was not flowing the way it should. The patient¿s whole arm went to sleep on him and when he was sleeping and it happened he would have to use his right arm to move his left arm. Arm was painful. The healthcare professional did not want to interfere with the lead the patient had implanted. Additional information received reported that the patient had the device for dystonia. The patient had numbness in the fingers, pain in the neck and their neck tipping was a part of their dystonia and was not device related. The patient also had comorbidity of depression and anxiety. The device had been implanted to try and help the patient and had been prescribed prior to patient being able to be considered for a surgery to remove a nerve in his neck. The deep brain stimulator did not seem to be working for the patient¿s issues. There was nothing wrong with the system, no impedance issues and it worked as designed. The patient wanted the device removed, it had not been decided what to do. The patient had some mental issues so he did not understand the therapy. The patient had thought that with the device he would have no more pain. The patient had not event gotten a little straightness in his neck and was not walking straighter, the patient was very upset and wanted to get better. It felt funny under where the device was which had started 2 months after implant. The pain was waking the patient up. The pain would be in his right arm and then a couple of days later it would in his left arm and the patient would have to use his opposite arm to move his arms. It was noted that the patient had gotten a second opinion and was told the pain was from the device and that something had been done wrong. The patient was told that ¿they had gone from 1 to 1000 instead of 1,2,3,4. ¿ the patient had not felt like himself and was very uncomfortable with the device. The patient¿s healthcare professional was going to remove the device during the month of this report but the patient was just told they would wait till after the other operation instead. Reference manufacturer¿s report number: 3004209178-2014-20672.

Manufacturer Narrative
Product id 37603, serial# (b)(4), implanted: 2014 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# va0ery5, implanted: 2014 (b)(6); product type lead product id 37603, serial# (b)(4), implanted: 2014 (b)(6); product type implantable neurostimulator product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0ccdl, implanted: 2013 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension. (b)(4). It was unclear whether the device was indicated for use with dystonia or parkinson¿s.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4214508
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« Reply #111 on: November 08, 2014, 12:36:15 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that the pediatric patient was implanted without the mother¿s consent after he was born in 2010. The mother claimed it was implanted for a study and ¿she was threatened if she did not have the procedure done for her son. ¿ she originally stated that all she wanted to know was what the device was and how to get it out of her son because she did not agree to have it implanted. The mother stated that she could not leave her son around any routers, computers, 4g cellphones, or gps systems because if he got near them ¿he stood straight up like he was being electrocuted, his face began to change to a purple-red coloration, and his arm began twisting and contorting. ¿ he could not be taken to doctor¿s or lawyer¿s offices because the electronics there could cause the symptoms. The mother also claimed that the device was being controlled remotely and that radio waves had been used on it. Her son could walk and talk when the device was off, but ¿when you turn the stimulator on he could not do anything. ¿ the mother also mentioned that the implanted device was ¿expired¿ and had ¿(b)(6) gel in it or on it. ¿ she had taken her son to many neurosurgeons and neurologists, even though the primary doctor refused to seek a second opinion, but no one wanted to him because he was involved in the study. The mother provided x-rays of the implanted device. She stated that her son ¿was going to die because of this¿ and had a ¿class four brain bleed, hydrocephalus,¿ and another disorder that could not be understood. She would not comment on what her son was diagnosed with that could lead to death. The mother was very difficult to follow and it was unclear what was factual or not.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, serial# unknown, product type: extension. Product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4185990
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« Reply #112 on: November 08, 2014, 01:58:26 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that the patient experienced infection due to skin breakdown at the lead site in (b)(6) 2013, three years after implant. There were no other signs or symptoms of infection. The right lead was cut and explanted. The hcp ¿got the lead stopped working¿ and ¿wrapped it in the plastic tube. ¿ the infection resolved. On (b)(6), the patient¿s limbs became rigid and the patient suspected the left lead had stopped working. It was found that the implantable neurostimulator (ins) was off. The ins was turned on and reprogramming was performed. The patient was ¿good¿ after reprogramming.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4182435
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« Reply #113 on: November 08, 2014, 08:45:42 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator. (b)(4).

Event Description
It was reported that around (b)(6) 2013, the patient¿s symptoms had gotten worse, they had tremor on their right side, and their limbs were distorted. After the implantable neurostimulator (ins) was implanted on the right side the patient¿s symptoms on their left side were controlled well. The patient was then implanted with an ins on their left side to control the symptoms on the patient¿s right side. On the same day the patient¿s healthcare professional adjusted the target position of the right ins. Following surgery the patient felt the left ins was heavier than the right ins, but the symptoms were controlled well. On (b)(6) 2014, the patient¿s limbs were trembling, their joints were distorted and their symptoms had gotten worse. The patient was reprogrammed on (b)(6) 2014, but their symptoms did not improve. Follow up with a manufacturing representative indicated that the cause of the event was not determined and it was unknown if intervention was done or if the patient was receiving effective therapy. No interventions or outcome were reported regarding this event. Additional information could not be obtained. Should additional information be received the event will be updated. Refer to manufacturer report #3004209178-2014-18342.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4144132
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« Reply #114 on: November 08, 2014, 08:46:23 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4134805
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« Reply #115 on: December 05, 2014, 08:53:52 AM »

Model Number NEU_UNKNOWN_LEAD
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported that the patient had experienced deficits just prior to placing the left side lead during a stage 1 procedure for a deep brain stimulator. The right lead had already been successfully placed just prior to the left lead. The patient had been opened up to place the lead into the left globus pallidus (gpi) when the healthcare professional had noticed deficits which included a weak right arm and the patient was not coherent. Surgery was stopped and the left side was capped with a burr hole cap without placing the lead and patient was closed up. The right lead was kept in. The healthcare professional suspected an intra-operative stroke. The patient had a computerized tomography (ct) scan and the ct was negative and the patient¿s deficits were rebounding, the patient knew what city they were in, was able to identify his wife and was able to squeeze hand more. They planned on doing an mri. Follow up information was received from the manufacturing representative two days after report and no mri had been done. It was unknown if any further troubleshooting was done or if the cause of the event was determined. It was also unknown how the patient was doing and at this time there were no further places to attempt to place the left side lead again. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4276892
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dennis100
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« Reply #116 on: January 10, 2015, 12:40:53 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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dennis100
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« Reply #117 on: January 10, 2015, 03:13:03 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334699
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dennis100
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« Reply #118 on: January 10, 2015, 05:42:10 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient¿s ¿effect was stable¿ and their ¿programmer could work normally¿ following the replacement of their implantable neurostimulator (ins) on 2014-(b)(6). However, in 2014-(b)(6) the patient¿s programmer reportedly ¿couldn¿t work. ¿ furthermore, ¿the patient¿s limbs were trembling when the device was turned on. ¿ the patient¿s physician reportedly ¿judged the cause as lead disconnection. ¿ the patient¿s lead was replaced as a result. Following the lead replacement, ¿the patient¿s symptom got better and the programmer could work. ¿ it was noted the ¿patient didn¿t fall down¿ at that time. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant: product id 3389-40, lot# 0204990374, implanted: 2011-(b)(6), product type lead. (b)(4). Device evaluation: analysis of the lead found ¿all four conductors were broken 3. 3 cm from the proximal end of the lead. There was also breached esc (environmental stress cracking) 8. 8 and 9. 6 cm from the distal end of the lead. ¿ it was also noted that ¿all circuits were open¿ during functional testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4325534
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dennis100
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« Reply #119 on: February 07, 2015, 07:12:30 AM »

Model Number 37602
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3387s-40, lot# v802373, implanted: (b)(6) 2012, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# v688050, implanted: (b)(6) 2011, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. (b)(4).

Event Description
It was reported that the patient was experiencing a shocking/jolting sensation. Electrode and therapy impedance testing was done, no issues were found. There was intermittent tingling down the patient¿s right arm but it had not happened every day. The patient noticed an occasional shock sensation down the right arm. The patient was going to keep a log of events for the future. The patient had not had this sensation until after the battery change on (b)(6) 2014. It was unknown when the first time that this had occurred was. It was noted that this was an initial patient visit. The patient was alive with no injury. There was also a burning sensation down the right arm. No outcome or intervention was reported. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4402985
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