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Author Topic: Deep brain stimulator - Shaking  (Read 11764 times)
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dennis100
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« on: January 18, 2014, 12:37:48 AM »

Model Number IPGNEURO
Device Problem Electro-magnetic interference (EMI)
Event Type  Malfunction  
Manufacturer Narrative
Event Description
It was reported the patient experienced a loss of therapeutic effect following an environmental exposure. They started shaking badly going through a fast food restaurant drive thru. The symptoms decreased after the patient left the are of the drive thru.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386201
« Last Edit: January 10, 2015, 02:23:54 AM by dennis100 » Logged
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« Reply #1 on: January 18, 2014, 06:53:00 AM »

Model Number 7426
Device Problems Intermittent continuity; Electro-magnetic interference (EMI); Inappropriate shock
Event Type  Malfunction  
Event Description
It was reported that the patient's implantable neurostimulator turned itself off. The patient experienced a return of shaking on the right side of their body and turned on the left stimulator and experienced a shocking sensation and a backache. The patient expressed feeling the shocking sensation on the rods in their back. It was also reported that the shocks caused the patient to sleep for 2 1/2 hours. Additionally it was reported that the patient had the sensation of surging energy when their head was turned a certain way and when going through store security. The patient had suffered a fall from tripping on a footstool 4-5 months prior to 2009. Additional information has been requested, but was not available as of the date of this report. Refer to manufacturer's report #6000032-2009-02818.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1430443
« Last Edit: January 10, 2015, 02:24:21 AM by dennis100 » Logged
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« Reply #2 on: January 19, 2014, 11:58:09 PM »

Model Number 7426
Device Problems Electro-magnetic interference (EMI); Malfunction
Event Type  Malfunction  
Manufacturer Narrative
(b) (4).

Event Description
It was reported that the pt experienced a loss of therapeutic effect following cauterization for a skin condition. It was noted that the pt experienced shaking in his hand. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476510
« Last Edit: January 10, 2015, 02:24:59 AM by dennis100 » Logged
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« Reply #3 on: January 20, 2014, 02:15:46 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 07/01/2009
Event Type  Injury  
Manufacturer Narrative
Event Description
It was reported the patient experienced a shocking or jolting sensation randomly in her arm and leg. She additionally reported some pulling sensations that lasted for a few seconds and then goes away. The symptoms have occurred in the bathroom, at the dining table and in a restaurant. There was no correlation between the patient's positions and the symptoms. No further outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463139
« Last Edit: January 10, 2015, 02:25:31 AM by dennis100 » Logged
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« Reply #4 on: January 21, 2014, 02:19:54 AM »

Model Number 7426
Device Problem Failure to read input signal
Event Date 09/25/2009
Event Type  Injury   Patient Outcome  Other
Event Description
The pt visited the hospital and their battery status showed 3. 7 or 3. 8v. One week later the pt re-visited the hospital with shaking hands. It was impossible to take telemetry. The pt's device was explanted.

Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545798
« Last Edit: January 10, 2015, 02:26:04 AM by dennis100 » Logged
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« Reply #5 on: January 22, 2014, 08:50:33 AM »

Model Number 7426
Device Problem No Information
Event Date 12/18/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
(b) (4).

Event Description
It was reported the patient's dbs stimulation device was turned off on (b) (6) 2009. The hcp was to increase the patient's medications until replacement could occur. The patient was admitted to the hospital (exact date unk but after (b) (6) 2009) for increased shaking, inability to swallow, and inability to sleep. Device replacement was originally scheduled for (b) (6) 2009, but due to blood clots the surgery did not take place until (b) (6) 2009. No information was provided on the reason for device replacement. (reference mfr report # 3004209178-2010-00952).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614528
« Last Edit: January 10, 2015, 02:26:41 AM by dennis100 » Logged
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« Reply #6 on: January 27, 2014, 09:25:26 AM »

Model Number 37601
Event Date 08/09/2013
Event Type  Malfunction  
Event Description
It was reported the patient had their implantable neurostimulator (ins) replaced on the day of this report and they were shaking more than they were prior to implant. The reporter stated they were concerned that the patient¿s healthcare professional let the patient go home in that condition. The reporter further stated they were unable to use the patient programmer and did not know what needed to be done. It was noted the programmer showed 75% and ok. It was further noted the programmer showed stimulation was at 3. 09v and the patient was usually at 4. 3v and 4. 6v. Follow up information received from the healthcare professional (hcp) reported that the cause of the event was unknown and that impedances were normal. No surgical interventions had occurred and it was noted that the patient did not report any symptoms to the hcp regarding the event. It was unknown if hospitalization was required for the event. It was later reported that there was a loss of therapeutic effect. The patient was shaking and confused since the new implant was put in. It was noted that the patient was waking up in the middle of the night and asking questions about surgery that had already been discussed with the patient. The patient was scheduled for back surgery on (b)(6) 2013 and would be there for a little while. Patient was implanted but was not reprogrammed till a while later due to the patient being in and out of surgery. Patient had met with the manufacturing representative once and had some reprogramming done. The display was showing a ¿call your doctor¿ icon. There was an out of regulation (oor) condition. It was noted that when using the patient programmer to make changes was when the oor icon was showing up. Patient was unable to adjust stimulation. Additional information received reported the patient¿s battery was not turned on after battery replacement. It was noted that the manufacturing representative met with the patient and turned him back on with improvement in his tremor. Device was not related to the event. The date of the new implant was (b)(6) 2013. Patient was put back on his usual settings. Patient outcome was tremor improvement. It was noted that the date of onset was after the patient¿s rotator cuff surgery in (b)(6) 2013. Diagnostics were performed on (b)(6) 2013 and very high impedances were found at contact 1 on the left electrode. The cause of the issues was unknown though he had undergone shoulder surgery in (b)(6) 2013. Interventions taken were that the plus contact was switched from 1 to 2 on (b)(6) 2013. The patient had immediate improvement in right hand tremor and was requiring less voltage. Ins was changed in (b)(6) 2013. Patient had his l4 and l5 surgery on (b)(6) 2013 and was still recovering. Patient never had physical therapy for it and was doing arm exercises with more than the recommended 2 pounds. Since rotator cuff surgery the patient¿s right hand tremor had been worse. It was noted that the adjustment had helped some. It was noted that the patient was using a walker on (b)(6) 2013. Patient had normal facial expression, blink rate, voice volume w/mild tremor. Normal speed of gesticulations. The patient had minimal postural tremor in left hand and more prominent in the right and moderate. Trunk had some mild titubation exacerbated when standing or walking because of leg pain. Patient¿s gait with the walker was normal but had a decreased stride length and looked uncomfortable. It was noted that the night prior to this report the patient had shooting pain down his legs but no longer had that. Therapeutic impedance was high on left side. Postural tremor of right hand was minimal. Patient was able to hold a mug steady with minimal tremor after programming change. Left leg pain appeared better since the surgery on the day prior to this report. It was noted that since 2010 face/head injury and punch to abdomen and (b)(6) 2010 battery change the deep brain stimulator had never provided him with as good of relief as when initially implanted. It was noted that it was somewhat better after replacement on (b)(6) 2012. Patient felt it still was not as good as when it was initially implanted in 2006. Patient had various types of trauma that could have potentially damaged the deep brain stimulator. 0 contact was still best one after exploration of left electrode contacts. In the past the patient had some motor cramping/tightness on his left face and hand when his pulse width was increased to 90. On (b)(6) 2013 reported the patient went into the healthcare professional on (b)(6) 2013 with worsening of left leg pain. Patient had chronic back pain that had started about 10 years prior to this report. The patient had been in 5 motorcycle accidents and played hockey in high school with a number of hits and concussions. Patient also had concussions in his military years in his 20¿s. The patient¿s radiation of pain was more of a muscle spasm and cramping in the posterior and anterior thigh and had some numbness in the soles of both feet. There were no bowel or bladder problems. There was some tingling in the palms of his hands. There was no weakness in the hands or legs. The patient had some right shoulder issues felt to be the rotator cuff which had not been responsive to shots. Patient had been getting injections of l3/4 and l4/5 on the left and l5/s1 on the right and had been getting them for the past year prior to this report. Gates was mildly wide based and unsteady looking but was also painful when walking or standing. Patient was unable to relax legs. The patient had a mildly decreased vibration sense in the toes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530979
« Last Edit: January 10, 2015, 02:27:28 AM by dennis100 » Logged
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« Reply #7 on: January 27, 2014, 10:07:37 AM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was initially reported that the patient experienced a loss of therapeutic effect that began "the first of the week". It was stated that the patient had been "having a time getting up and down". It was stated that the patient saw the green light on for the programmer battery, but no other lights. The reporter tried to check the status of the implantable neurostimulator (ins), and tried turning the ins off or on, and tried a "soft reset", but there was no change in the light status. The reporter "made sure that the volume was on". The patient had an appointment scheduled with their doctor "at the end of (b)(6)". The last appointment was on (b)(6) 2013. Additional information received one day later reported that the patient "did not feel right". The patient's battery was checked and the only light that came on was for the programmer battery. There was "no top light". The "top light" did not turn on. It was stated that the patient was "shaky all over and did not feel good". It was stated that the patient would "just sleeping most of the time and he was not stead on his feet". They were unable to get to the neurologist until (b)(6) 2013. It was stated that the patient had "kind of felt like this all week". It was stated that the reporter took the 9v battery out of the programmer and moved the volume all the way up. They placed the battery back in, but it did not fit well so they got a new 9v battery. When the new battery was put in, they heard a beep. They tried to check the ins with the programmer again, but they were only seeing the light for the programmer battery. They were next to a cell phone, so they tried again, but they were still only able to see the programmer battery light. It wa s stated that the programmer was unable to communicate with the ins and the patient had a return of symptoms. It was noted that the patient had been doing physical therapy (pt). Two days later, it was reported that the patient was still unable to communicate between the programmer and the ins. It was noted that the patient was feeling "shaky and miserable". Later that day, it was reported that the patient had a loss of therapeutic effect. It was stated that the patient had lost therapy for 6 days and had a "full return of symptoms". The patient was asleep "all the time and not feeling good". The patient had tried to get stimulation on, but they were unable to get stimulation on and only one light was showing the patient programmer. The patient had an appointment the following day with a doctor. The patient was frustrated that they had not gotten any help. About one week later, the health care provider (hcp) reported that the cause of the event was because the battery needed to be replaced. They were unable to measure the impedances. It was stated that the battery was depleted. It was stated that patient had their ins replaced about two years ago. The ins was planned to be replaced. An x-ray was taken. On (b)(6) 2013 the patient was referred to a neurosurgeon for replacement. It was stated that the patient's parkinson's symptoms were "suddenly worse". The patient was not hospitalized and there was no injury. Additional information received 10 days later reported the patient¿s battery just went out and they did not feel it was long enough for having the implant from (b)(6) 2011 to (b)(6) 2013.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3539324
« Last Edit: January 10, 2015, 02:28:13 AM by dennis100 » Logged
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« Reply #8 on: March 28, 2014, 01:06:38 PM »

Model Number 37603
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported after the patient was implanted they felt shaking, they were depressed and mentally out of it and they hallucinated. It was noted, the patient was not programmed until a few weeks after the implant but the patient indicated that the unit¿s stimulation coupled with the medication contributed to it. It was noted, the patient was in withdrawal because too much of their medication was ¿taken away. ¿ it was stated this occurred one year prior to report. It was stated their doctor was in the process of adjusting their medication. It was noted, the patient had essential tremor and parkinson¿s disease tremors but their doctor chose ¿to go after to parkinson¿s disease tremors. ¿ it was noted they did not want to treat the essential tremor due to the patient¿s age and their health.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3628613
« Last Edit: January 10, 2015, 02:28:36 AM by dennis100 » Logged
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« Reply #9 on: September 06, 2014, 01:54:34 AM »

Model Number 37603
Event Date 04/15/2014
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# va07ll2v03, implanted: (b)(6) 2014, product type: lead. (b)(4).
Event Description
It was reported the patient never had therapeutic effect. The patient was still shaking since having the implantable neurostimulator (ins) put in. The ins was on and the patient wanted to know how to change the stimulation. The patient noticed a difference when the stimulation was increased. The patient was at 2. 1 volts and they turned up the stimulation to 2. 3 volts. The patient was going to turn up the stimulation to see if it helped with the shaking. The patient was in the hospital in the middle of (b)(6) to get their device put in and was released (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979385
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« Reply #10 on: October 12, 2014, 12:20:48 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was a loss of therapeutic effect. Patient was implanted with the deep brain stimulator about 3 years prior to the date of this report. The patient was quickly going back to shaking like prior to implant. The patient had been falling, dropping things and shaking lightly which had started about 3-4 months prior to the date of this report. It was noted that it had gradually gotten worse and worse and then the patient had started falling. On friday prior to the date of this report, the patient had fallen twice and he could not get up and was unable to get inside which was the worst he had fallen. The patient hurt his back and he had laid there for 3 hours. Since sometime towards to the end of (b)(6), the patient¿s shaking had gotten a little worse and he was unable to hold a glass in his left hand. It was noted that it appeared he would have a new implant sometime in (b)(6), as they were trying to get him in for surgery because ¿this thing was getting worse and worse. ¿ the patient had never turned his stimulation off before. The patient was unable to adjust stimulation after his granddaughter got a hold of his programmer and turned his stimulation down to 0 volts on 1 side, and he was now unable to turn it back up again. When the patient would try and increase stimulation, he would get an information screen but was unable to describe the exact picture on the screen. During the phone call the patient ended up adjusting something and was now able to increase the stimulation and was at 5. 3 volts on the left side and 4. 10 volts on the right, and the issue was resolved. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received a follow-up report will be sent.

Manufacturer Narrative
Product id 37085-60, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v833497, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v779188, implanted: 2011 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4089335
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« Reply #11 on: October 13, 2014, 12:39:46 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient experienced stable effects after the implant of their unilateral deep brain stimulation (dbs) system. However, the patient reported to the hospital at the time of report because their ¿symptoms weren¿t controlled well¿ for the month prior to report and the ¿dbs was almost not effective in the two days¿ leading up to report. The patient¿s right side was reportedly ¿shaking and rigid¿ with ¿no¿ control of their symptoms at the time of report. When initially attempting to check the patient¿s implantable neurostimulator (ins) it was noted the physician¿s programmer ¿couldn¿t connect¿ to the ins. Review of the patient¿s programming history found the patient¿s therapy parameters were set to a medium level. The patient¿s physician reportedly ¿suspected it was ins abnormal battery depletion¿ ¿considering the ins was only used for almost 14 months in normal usage. ¿ troubleshooting of the ins was performed and confirmed the patient¿s ins had not been reprogrammed in the year prior to report. Impedance testing found ¿normal¿ impedances. It was noted that as a result, ¿short circuit couldn¿t happen. ¿ it was also noted that ¿the extreme conditions that four electric shocks appeared negative and voltage was above 3. 6 volts never happened. ¿ the exact meaning of this statement was unclear at the time of report however. Further information has been requested regarding this information. It was noted that replacement of the ins was requested as a result of the event. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
(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=4081801
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« Reply #12 on: October 13, 2014, 12:41:34 AM »

Model Number 37603
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387s-40, lot# va01d5k, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708640, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va01ngu, implanted: (b)(6) 2012, product type lead; product id 37085-40, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

Event Description
It was reported the patient had fallen and broke their shoulder on (b)(6) 2014 and had surgery the following day. They had therapy for about 3 weeks and things were progressing. They thought their symptoms after surgery were worse than before but the last 2 or 3 days prior to report their symptoms had gotten much worse. They had worked with a physical therapist at home on the day of report and could barely walk across the room. They had more shaking getting started from a dead stop. There was a patient injury and a loss of therapeutic effect. It was noted the patient programmer batteries were dead and they had never used the programmer in two years. The patient changed the batteries and performed a check on the right side first. They saw a doctor and phone screen. After, they performed a check on the left side and they saw ¿on and ok¿ for the left side. The patient outcome was not provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4080014
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« Reply #13 on: October 13, 2014, 12:42:21 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 #14 on: October 13, 2014, 01:45:15 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 #15 on: November 08, 2014, 08:19:14 AM »

Model Number 37602
Event Date 09/10/2014
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v054407, implanted: (b)(6) 2008, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 7438, serial # (b)(4), product type programmer, patient; product id 37602, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387s-40, lot # v054407, implanted: (b)(6) 2008, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2008, product type extension. (b)(4).

Event Description
It was reported the patient had a shocking or jolting sensation. The patient was admitted to the emergency room on (b)(6) 2014 for shaking and shocking sensation over their entire body. It was stated that this started to occur three days prior to report. The patient believed this was device related and had attempted to turn their device off but the shocking continued. 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=4139769
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« Reply #16 on: November 08, 2014, 08:19:51 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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« Reply #17 on: December 05, 2014, 11:53:06 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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« Reply #18 on: January 10, 2015, 02:29:25 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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« Reply #19 on: January 10, 2015, 03:51:57 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 #20 on: February 07, 2015, 07:14:12 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 #21 on: February 07, 2015, 07:14:50 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 #22 on: February 07, 2015, 11:59:05 AM »

Model Number 37612
Event Type Malfunction
Event Description
It was reported that there was a shocking or jolting sensation from head to toe, the patient felt a ¿zing¿ go through her on the prior to the date of this report about 4pm while reading. There was a loss of therapeutic effect and the patient was shaking all over. The shaking had started on the day prior to the date of this report at 4pm. The patient had charged her implantable neurostimulator (ins) on thursday prior to the date of this report and on the night prior to the date of this report because on sunday prior to the date of this report the battery was showing empty. It had taken 3 hours to charge on the day prior to the date of this report but the patient had fully charged it. The patient programmer showed stimulation was on. The patient had met with their manufacturing representative on (b)(6) and troubleshooting included palpation and impedance measurements were done without shocking sensation. Initial patient settings were 4. 9v left and 5. 1v right. The manufacturing representative believed the shocking was due to the ins being turned on at such high amplitude settings, the patient was reprogrammed to a bipolar mode with lower amplitudes, a range of 3. 5v. The patient was implanted for multiple sclerosis tremors which can be multifocal. The manufacturing representative had thought the device was possibly shut down due to her needing to recharge. Following the reprogramming the patient was received good efficacy at lower settings.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va02kcc, implanted: (b)(6) 2012, product type: lead; product id 3387s-40, lot# va012tp, implanted: (b)(6) 2012, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type(b)(6) extension; product id 37651, serial# (b)(4), product type: recharger. (b)(4). (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4386846
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« Reply #23 on: February 07, 2015, 11:59:48 AM »

Model Number 37603
Event Date 12/10/2014
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va08kln, 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 3387s-40, lot # v233444, implanted: (b)(6) 2010, product type lead; product id 7438, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # v233444, implanted: (b)(6) 2010, product type lead. (b)(4).

Event Description
It was reported the patient had a loss of therapeutic effect. The patient had the implantable neurostimulator (ins) in their upper left chest for the right side of their body. For the last couple of days the patient¿s right arm had been shaking. The reporter stated the implant near the right collar bone did not work because it was in the wrong spot in the patient¿s brain so it did not work. It had not worked for a while so it was not on. The reporter stated they put it in the wrong spot in the brain. The ins was on and there was no known accident or incident related to this complaint. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377933
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« Reply #24 on: April 19, 2015, 09:40:27 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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« Reply #25 on: September 07, 2015, 07:56:57 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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« Reply #26 on: September 07, 2015, 07:57:37 AM »

Model Number 37603
Event Type Malfunction
Event Description
Information was received from the health care professional (hcp) regarding the patient felt like the stimulation system was not working correctly. The patient would shake and they felt the device was not working. The patient checked the battery and it said on and ok but he could barely feed himself. The tremor was not being adequately controlled by the stimulator. No impedance measurements were taken. No other symptoms were reported. The patient was implanted for parkinson's dual and movement disorders. Further follow-up is being conducted to determine what troubleshooting was performed, what actions/interventions were taken to resolve the issue, what was the cause of the issue, and if the issue had been resolved. If additional information is received, a follow-up report will be sent. Please see manufacturer report #3004209178-2015-15809 for information on the patient's concomitant system.

Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387-40, lot# j0333616v, implanted: (b)(6) 2003, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387-40, lot# j0322212v, implanted: (b)(6) 2003, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4992850
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« Reply #27 on: September 19, 2015, 03:02:22 AM »

Model Number 37602
Event Type Malfunction
Event Description
A consumer with an indication for use of parkinson's dual and movement disorders reported an elective replacement indicator (eri) code being seen in (b)(6) 2015. Prior to the eri the patient had spent several early mornings shaking with high blood pressure which was why the patient checked the eri. There were no falls or traumas that were possibly related and no allegation against longevity or dissatisfaction with longevity. The device was on and patient was still receiving therapy but was experiencing symptoms of shaking which were reported as sudden in onset. According to the patient the event coincided with wearing a life alert necklace and eri message. The patient had an appointment scheduled for surgery on (b)(6) 2015 to replace the left side battery. Reference manufacturer's report number:3004209178-2015-17007 for patient's left side device that was being replaced.

Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3389s-40, lot# v939343, implanted: (b)(6) 2012, product type: lead. Product id: 3389s-40, lot# v959668, implanted: (b)(6) 2012, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5042692
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