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Author Topic: Deep brain stimulator - Hand  (Read 24120 times)
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dennis100
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« Reply #30 on: August 10, 2014, 06:15:31 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3922599
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dennis100
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« Reply #31 on: September 06, 2014, 12:37:05 AM »

Model Number 7428
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that a patient being treated for parkinson¿s disease went to the hospital for programming in (b)(6) 2014 and that at that time the patient¿s physician found their battery had depleted. The battery depletion was reported to have been ¿normal battery depletion. ¿ the patient was reported to have experienced right hand rigidity and trembling, difficulty walking, and pain at the implant site and to have experienced these symptoms following the replacement surgery. Additional information has been requested, but was unavailable at the time of this report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013492
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dennis100
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« Reply #32 on: September 06, 2014, 02:20:34 AM »

Model Number 7428
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that a patient being treated for parkinson¿s disease went to the hospital for programming in (b)(6) 2014 and that at that time the patient¿s physician found their battery had depleted. The battery depletion was reported to have been ¿normal battery depletion. ¿ the patient was reported to have experienced right hand rigidity and trembling, difficulty walking, and pain at the implant site and to have experienced these symptoms following the replacement surgery. Additional information has been requested, but was unavailable at the time of this report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013492
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dennis100
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« Reply #33 on: September 06, 2014, 05:05:21 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4024800
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dennis100
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« Reply #34 on: October 12, 2014, 06:11:41 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4096519
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dennis100
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« Reply #35 on: October 13, 2014, 12:33:16 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078338
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dennis100
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« Reply #36 on: October 13, 2014, 01:58:54 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078222
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dennis100
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« Reply #37 on: November 08, 2014, 08:36:48 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4143638
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dennis100
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« Reply #38 on: November 08, 2014, 08:37:23 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4134805
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dennis100
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« Reply #39 on: December 05, 2014, 11:54:56 PM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4224171
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dennis100
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« Reply #40 on: January 10, 2015, 02:18:31 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340112
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dennis100
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« Reply #41 on: January 10, 2015, 03:16:01 AM »

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515835
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dennis100
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« Reply #48 on: April 19, 2015, 02:23:20 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4637974
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dennis100
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« Reply #49 on: June 08, 2015, 07:13:22 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4774612
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dennis100
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« Reply #50 on: July 15, 2015, 11:50:07 PM »

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

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

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

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

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

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

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

Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient; product id 3387s-40, lot# va02nm4, implanted: (b)(6) 2012, product type: lead; product id 7482a95, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387-40, lot# j0401949v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 7438, serial# (b)(4), implanted: (b)(6) 2004, product type: programmer, patient. (b)(4).

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5010764
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dennis100
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« Reply #54 on: September 07, 2015, 07:47:29 AM »

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

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

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

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

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

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

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

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

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