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Author Topic: Deep brain stimulator - Arms  (Read 52318 times)
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dennis100
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« Reply #120 on: February 07, 2015, 09:06:41 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking or jolting sensation. Since the patient¿s implantable neurostimulator (ins) was replaced in (b)(6) 2013 the patient had experienced significant shocks every time the ins was turned off with the patient programmer or during reprogramming. The healthcare professional (hcp) observed the shocks the day prior to this report when they were reprogramming the patient. The hcp stated the shocks were severe and lasted less than a couple seconds. The shocks were more severe when the ins was turned on. The patient felt the shocks on the left side of their face, arm, and leg. The hdp did not decrease stimulation before turn the ins off because it happened during reprogramming when they were changing the electrode configuration and the amplitude automatically dropped down to zero. The patient felt the shocks when the stimulation was at 0. 0v. The hcp stated that impedances may have been a little on the low side around 700-800 ohms, but nothing out of range. The patient was programmed at c+, 1- at 3. 5v, pulse width of 90, and a rate of 130 hz. The patient had previously been programmed at 4. 0v and a pulse width of 90. The ins was not programmed using interleaving and the ins was in voltage mode. Bipolar programming had not been tried. 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
Concomitant medical products: product id 3387s-40, lot# v311441, implanted: (b)(6) 2010, product type: lead; product id 37642, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 7482a66, 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=4393408
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dennis100
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« Reply #121 on: February 07, 2015, 11:09:57 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient was experiencing paresthesia and difficulty walking. The symptoms had occurred following implant. The patient had had problems with her arms since the device was implanted in (b)(6) 2012. Both arms had problems, arms were swollen at night time and some nights it was more than others. The patient kept twisting and turning at night because of her arms. After discussing with her healthcare professional the patient was told she was fine. The healthcare professional was seen a long time ago and had not been seen since. The patient had had a problem with their device since surgery and had gone through a 2nd surgery on one side, they had to open up the patient¿s head and do a wiring thing. The patient¿s wires were crooked and the patient had had surgery but they were still the same, the patient had not seen any change. The patient was unsure what was wrong with it because they were having problems with their head but now was having trouble with their neck. Every time the patient saw their healthcare professional they got numb on one side which had never happened before, they had had it before but it had gone away. The patient had had it in both legs prior to surgery. After her legs were fine and her arms, but she could not sleep at night. The patient had a funny feeling in her arms. The healthcare professional told the patient that it had nothing to do with surgery. It was noted that it might be an iron deficiency, but the patient wondered why their legs were not affected since they believed an iron deficiency would not impact just their arms. The patient¿s walking was very bad, she fell on her face when she walked and one time she fell and broke her hand but was told by her healthcare professional that this was not from parkinson¿s. The patient had an appointment scheduled for (b)(6) 2014. The patient had had a computerized tomography (ct) scan and found out there was a problem with the wiring in the brain that they had never told her about. The ct had been taken at the second surgery in (b)(6) 2012. The patient also had an appointment scheduled for (b)(6). No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2015-00143.

Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4384377
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dennis100
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« Reply #122 on: February 07, 2015, 11:10:40 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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dennis100
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« Reply #123 on: March 07, 2015, 04:12:08 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that a day after the patient¿s device was implanted, she used an electromagnetic therapy device close to her chest for wound treatment for 4 days. Two day¿s after she started using the device, she experienced a burning sensation in her abdomen. Approximately a month later, the patient had a tingling sensation in her arm, which got worse about a week later. Reprogramming was performed several times but the cause of the event was unknown. The patient was hospitalized for treatment. As of (b)(6) 2014, the patient still experienced tingling sensations and felt weak. It was unknown if the patient was receiving effective therapy. If additional information becomes available, a supplemental report will be submitted.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4553593
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dennis100
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« Reply #124 on: March 07, 2015, 04:49:39 AM »

Model Number NEU_INS_STIMULATOR
Event Type Death
Manufacturer Narrative
Date of death: please note the patient's date of death was unavailable at the time of report. The date reported reflects the date the attached literature article was published online. Other: psychosis. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

Event Description
Thavanesan, n. , gillies, m. , farrell, m. , green, a. L. , aziz, t. Deep brain stimulation in multiple system atrophy mimicking idiopathic parkinson's disease. Case reports in neurology. 2014;6(3):232-237. Doi: 10. 1159/000368571. Summary: deep brain stimulation (dbs) is approved for idiopathic parkinson¿s disease (ipd) but has a poor evidence base in parkinson-plus syndromes such as multiple system atrophy (msa). We describe the clinical and neuropathological findings in a man who was initially diagnosed with ipd, in whom dbs was unsuccessful, and in whom msa was unexpectedly diagnosed at a subsequent autopsy. This case report highlights that dbs is often unsuccessful in msa and also demonstrates that msa can masquerade as ipd, which may explain treatment failure in a small group of patients apparently suffering from parkinson¿s disease. Additionally, it also presents a case with an unusually long duration of disease prior to death, comparable only to a handful of other cases in the literature. Reported event: one (b)(6) male patient underwent 2-stage bilateral deep brain stimulation (dbs) implant for parkinson¿s disease in (b)(6) 2008. Stage 1 initially gave positive results barring an episode of confusion, hypotension and reduced glasgow coma scale (gcs) score attributed to overstimulation. Titration was effective, and the patient was switched from regular madopar to prn. Stage 2 was complication free aside from transient calibration paresthesia. Medications were stopped two days postoperatively with good gait, no tremor, no freezing and improved left arm mobility. A health care provider (hcp) and the patient specifically reported improvement in rigidity and gait. The patient was discharged three days later. The patient subsequently deteriorated after two weeks, returning to pre-operative medication doses, with his symptoms worse than preoperatively. The patient experienced confusion, short-term memory impairment and hypertonia in the left arm. Subsequent titration helped minimally. In the subsequent four years until time of death, the patient developed episodes of psychosis, dopamine dysregulation syndrome, iga nephropathy, chronic renal failure and ultimately terminal clostridium difficile colitis. Neuropathological examination, performed six years after surgery during the patient¿s autopsy, confirmed the placement of dbs electrodes in the subthalamic nucleus (stn). The neuropathological findings were those of multiple system atrophy (msa). The pathological diagnosis was based on extensive striatal and subcortical white matter accumulation of ¿-synuclein coupled with profound depletion of the neurons from the striatum and substantia nigra with atrophy and gliosis. Oligodendroglial ¿-synuclein inclusions were also very extensive in cerebral and cerebellar white matter, and the middle cerebellar peduncle also showed prominent ¿-synuclein-positive glial inclusions indicating elements of both a striatonigral and olivopontocerebellar pattern of distribution. Noteworthy was the finding of prominent ¿-synuclein-positive glial inclusions adjacent to the dbs insertion site in the stn. It was noted that incorrect preoperative idiopathic parkinson¿s disease diagnose showed positive initial response to surgery followed by rapid decline secondary to progression of msa and subsequent death. The source literature did not include any specific device information. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4521234
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dennis100
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« Reply #125 on: April 19, 2015, 02:28:11 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va090aq, implanted: (b)(6) 2013, product type: lead; product id 3389s-40, lot# va08ytx, 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 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. (b)(4).

Event Description
It was reported that there was a left lead fracture adjacent to the stimloc. The action required as a result of the event was a replacement. Diagnostic testing and troubleshooting included impedance testing and x-rays. The issue was not resolved and the cause was not determined. Patient symptoms associated with the event were increasing dysphagia and rigidity in the left upper extremity. The location of the symptom was the lead location. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4565375
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dennis100
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« Reply #126 on: May 09, 2015, 02:42:05 AM »

Model Number 37601
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id 3387, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

Event Description
It was reported that the patient experienced myoclonic jerks of arms and legs. Corrective actions included medication added, discontinued or dose changed. Depakote was started after lab work was reviewed on (b)(6) 2014. The event was not resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4662492
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dennis100
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« Reply #127 on: June 08, 2015, 05:59:15 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported the patient had chest pain, a loss of effect, and a lack of symptom control since the replacement of their implantable neurostimulators (ins). The patient had been having slurred speech and issues with controlling their tongue. On the day prior to this report, the patient had bit their tongue bad, which had made their speech even worse. The patient¿s jaw was tight and they almost broke a tooth. Every time the patient had their ins replaced, it took them three months to get the ins properly adjusted and for them to receive any benefit. The patient also had an increase in rigidity and dystonia in their neck and extremities with their left being worse than the right. The patient met with their healthcare professional (hcp) a day prior to this report because their pain was so bad they thought they were having a heart attack. The pain was located in the patient¿s chest near the ins and in their armpits. An x-ray was done and the patient was going to follow up with their cardiologist. The patient was evaluated by their cardiologist and cardiac etiology was ruled out. Impedances were checked and one of the contacts was not being used. Impedances of electrode zero were measured to be greater than 40,000 ohms on the left side. The left ins was programmed to 2-, 3+ at 4. 7v, 90 usec, and 145 hz. Impedances of electrode three were measured to be greater than 40 ,000 ohms on the right side. The right ins was programmed to 1+, 2- at 4. 2v, 90 usec, and 145 hz. Therapy impedances were measured to be within normal limits on both sides. The patient¿s hcp planned on reprogramming the ins to get efficacy. The cause of the event was not determined. A troubleshooting revision had been scheduled for (b)(6) 2015 due to the high impedances. During the revision, the hcp opened the right incision and noticed the bottom two screws on the ins were not tightened. The hcp loosened all four screws, dried off the extension, and retightened everything. The right side bottom connector for the ins and extension still seemed not tight and there was a small gap, but everything was tightened down. Impedances were then tested and all impedances were within normal limits. The same issue occurred when the left side incision was opened. After the revision, all impedances were within normal limits on both sides and no further troubleshooting was done. Refer to manufacturer report #3004209178-2015-09832.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v443426, implanted: (b)(6) 2010, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802318
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dennis100
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« Reply #128 on: June 08, 2015, 06:00:13 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0apc0, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot # va0apc0, 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. (b)(4).

Event Description
It was reported the patient had a shocking or jolting sensation when they turned their head a certain way or sometimes when they turned their head left. The patient felt a shock like sensation in their chest and arm area that only occurred when the implantable neurostimulator (ins) was on. The patient¿s grandson had stepped on the ins at some point and the patient thought the issue started soon after. The patient had thought they had neck issues that created the sensation. When the patient met with their healthcare professional (hcp), they were more convinced the issue was related to their ins. Impedances had been checked and some electrodes were out of range. The following high impedances were measured on the right side at 3v: c-8 = 2521, c-9 = 2293, 8-9 = 4381, 8-11 = 4647 and 9-11 = 4194 ohms. The ins was turned off for three hours and the patient did not feel the sensation. X-rays were normal and everything else read normal. The patient had no obvious loss of benefit, but they were not doing as well as they once were. The patient was under a tremendous amount of stress and they had stopped exercising. The patient did have a reduction in symptoms control, but they also had a urinary tract infection that had caused some decline in the past. The cause of the event had not been determined and the patient had not recovered. The symptoms/issue were ongoing and the hcp was trying to figure out the problem. 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=4801009
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dennis100
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« Reply #129 on: June 08, 2015, 07:06:46 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the essential tremor patient experienced ¿shocking sensations and paresthesias¿ in his left arm, torso, and leg with the sensations ¿not limited to a specific location. ¿ the patient reportedly ¿could induce the sensation when pressing onto the implantable neurostimulator (ins),¿ however sometimes the shocking sensations would also occur ¿without any external influence. ¿ the patient additionally experienced ¿intermittent stimulation,¿ whereby the patient¿s tremors ¿reoccurred regularly, as if the ins was turned off. ¿ it was stated the patient experienced ¿less than 50% therapy relief¿ on his left side. These tremors would occur ¿sometimes for several hours. ¿ the tremor would then ¿disappear on its own later, as if the stimulation was turned back on. ¿ it was noted the patient lost his paresthesia and therapy within 24 hours of having his ins interrogated with a physician programmer at the time of report. Impedance testing was performed and found ¿fine¿ impedance values. X-ray imaging ¿didn¿t show any anomalies in the extensions/leads. ¿ the patient¿s stimulation was reprogrammed to a bipolar stimulation setting in an attempt at troubleshooting the situation; however, it was noted that ¿even with the bipolar stimulation there was a shocking sensation when touching the ins. ¿ the patient¿s ¿stimulation was still intermittent¿ and a revision surgery was planned for the patient as of 16 days after initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743368
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dennis100
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« Reply #130 on: July 15, 2015, 11:16:31 PM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s lead extension started to slide down his skull soon after implant. Eventually it slid off of his skull. Skin erosion was also reported. This was followed by decreased benefit. It was also reported that when the patient was on vacation he felt his device turning on and off. He felt tingling in his arm and leg like when the device was turned on/ off. The patient¿s implant was revised and replaced in 2013. The extension was removed but the lead remained implanted. No outcomes 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=4813073
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« Reply #131 on: July 15, 2015, 11:17:44 PM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the essential tremor patient experienced reduced therapy post-operatively with ¿less than 50% therapy relief. ¿ the patient also experienced a shocking sensation down their arm and spasms. These issues were reported to have occurred after the patient had a large fall. Prior to the fall it was noted he patient ¿had good tremor suppression. ¿ a revision procedure was performed whereby the patient¿s scalp was opened and it was observed the lead was ¿visibly fractured. ¿ the lead was ¿fractured slightly distal from where bone cement secured the lead. ¿ it was noted the ¿damage was detected capping the lead. ¿ impedance testing was performed with an external neurostimulator (ens) at that time and found that contact 0 was ¿open. ¿ as a result, the bone cement present with the lead was drilled and the lead was removed and replaced with a new lead. The patient was to have their therapy switched on 17 days aft er initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant medical products: product id 3387-28, lot# unknown, implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841423
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« Reply #132 on: July 15, 2015, 11:30:01 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that stimulation was turning off on its own and the patient did not know what was causing it. The patient was not feeling confident with the patient programmer and inquired if he was reading the programmer right. The patient had had programming done in (b)(6) 2015 and programming was not helping with symptoms. The patient had called their healthcare professional about this. On (b)(6) 2015, the implantable neurostimulator (ins) was turned off and he was seeing stimulation at 2. 5v on one side and 3. 5v on the other side and it said off on the top. The ins was turned back on. The ins had turned off on saturday prior to the date of this report and it was a normal day. It was off on monday and the left arm was paralyzed, he could not lift his arm or move his elbow over his shoulder. The patient takes 9 doses of sinemet and had stated he had ¿worst days and bad days and the bad days are not good. ¿ the patient was in a wheel chair. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37085-60, 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=4865984
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« Reply #133 on: August 08, 2015, 09:38:05 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was a tingling following a battery replacement. The patient started having numbness on one side of his face including the lips 2 weeks prior to the report. The symptoms were worse in the morning but would subside if the patient pressed on the implant with his hand. Imaging was performed and impedances were checked and nothing abnormal was found. Additional information received one month later reported there was a shocking sensation at the implantable neurostimulator (ins) pocket site and a stroke symptom at the right arm. It was a gradual change in therapy/symptoms. Towards the end of the device in (b)(6) 2015, the patient felt stroke symptoms at the right side of the arm. They turned the stimulation off. When the patient received their last implant in (b)(6) 2014, that is when he noticed a strange feeling initially (not shocking) and he had reprogramming sessions; however, it kept getting worse. When the patient would turn the stimulation on in the mornings, his lips would go numb for about a minute and then it would subside. He had the same experience with the first implant. The month prior to report whenever he reached he felt shocking on the whole right side of his body. There were intermittent impedances. Impedances would change with positional changes. The patient had a replacement done in (b)(6) 2015 for normal battery replacement. When they replaced the ins and extension, they both tested well. The new ins was working with no issues. The ins replacement resolved the shocking issue. No trauma or falls were reported and there were no unrelated medical procedures. The patient recovered completely.

Manufacturer Narrative
Concomitant products: product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v140982, implanted: (b)(6) 2008, product type: lead. Product id: 3387s-40, lot# v134483, implanted: (b)(6) 2008, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4919122
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« Reply #134 on: August 08, 2015, 09:39:07 AM »

Model Number 37601
Event Date 06/12/2015
Event Type Malfunction
Event Description
Additional information reported that the patient did not have concerns with their device or therapy now. The patient received assistance from their healthcare professional or manufacturer representative on 2015 (b)(6) and their concerns were resolved.
Manufacturer Narrative
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0gvdy, implanted:(b)(6) 2014, product type: lead. Product id: 3387s-40, lot# va0gvdy, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension. (b)(4).

Event Description
It was reported the night prior to this report, the patient started feeling a vibration in their right arm at the inside of their elbow every ten seconds. The patient¿s pain level was a three on a scale of 1-10. 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=4882932
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« Reply #135 on: August 08, 2015, 09:39:51 AM »

Model Number 37612
Event Date 06/10/2015
Event Type Malfunction
Event Description
It was reported the patient programmer was not powering on and the recharger displayed a ¿call your doctor¿ icon and a 375 antenna failure error code. New batteries were tried in the programmer, but the issue was not resolved. The new batteries were brand new and the patient confirmed they were positioned correctly. The patient was not able to recharge the implantable neurostimulator (ins). When the patient tried to recharge the ins, they saw the ¿call your doctor¿ icon. Normally, the patient recharged just about every day. The patient was having a return of symptoms and their arm was shaking terribly since the day prior to this report. Upon device return, analysis of the patient programmer found the antenna jack was resoldered as a preventative measure. Upon device return, analysis of the recharger found the recharge antenna failed. 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
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v181305, implanted: (b)(6) 2009, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: neu_unknown, serial# unknown, product type: unknown. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4882203
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« Reply #136 on: August 08, 2015, 09:40:41 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 #137 on: September 07, 2015, 07:36:05 AM »

Model Number 37612
Device Problems Failure to deliver energy; Communication or transmission issue
Event Type Malfunction
Manufacturer Narrative
Product id 37651, serial# (b)(4); product type recharger product id 3387-40, lot# v000198, implanted: 2005 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2004 (b)(6); product type extension product id 37651, serial# (b)(4); product type recharger. (b)(4).

Event Description
A consumer reported that they did not think their recharger was working to charge the implantable neurostimulator (ins) because their tremor came back suddenly and was very bad. The patient had poor telemetry or no telemetry when recharging and they were having difficulty recharging. The patient was told to charge for 20 minutes a day and they had been doing that. After positioning the antenna over the ins, the patient was able to get 6-8 coupling bars and the ins was charging up to about a quarter full. The recharger was working normally and the patient was able to charge successfully. The ins was confirmed to be off at the time of this report, but the patient was able to turn the ins back on. Initially the patient felt an uncomfortable tingling sensation down their arm, but the sensation dissipated during the call. The patient's tremor had also gone away. The patient's indication for use is parkinson's dual and movement disorders. Troubleshooting had resolved the issue and the patient was going to follow up with their health care provider if they continued to have symptoms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5031373
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« Reply #138 on: September 07, 2015, 07:36:49 AM »

Model Number 37602
Event Date 07/11/2015
Event Type Injury
Event Description
It was reported the patient was admitted to the emergency room due to a loss of therapeutic benefit. The patient first noticed the loss of deep brain stimulation (dbs) benefit last night and today, the patient¿s arms and legs were moving wildly. The patient was brought to the emergency room by ambulance. Both of the patient¿s implantable neurostimulators (ins) were checked using the patient programmer and they were both on and at 3. 4v. Impedances were not checked. The patient indicated that prior to being taken to the emergency room, a nurse at their assisted living center may have made changes to their therapy, but they did not know what changes were made. The last reprogramming session was 3-4 months ago. The patient had no falls or trauma and had not been had any recent medical tests or environmental exposure. The reporter wanted to know if a manufacturing representative could check the inss. 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
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389-40, lot# v000631, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient. Product id: 3389-40, lot# j0537580v, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4961817
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« Reply #139 on: September 07, 2015, 07:37:37 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6). Product type lead. (b)(4).

Event Description
The health care professional (hcp) reported via a manufacturer representative (rep) that there was troubleshooting needed for an imp edance issue. The patient related to the event had severe intractable bilateral essential tremor of the upper extremities, head, trunk, and voice tremor. The indication for use was essential tremor. The patient had a bilateral ventrointermediate nucleus deep brain stimulation (dbs) implanted in (b)(6) 2014. The consumer reported improvement of her symptoms since the dbs had been instituted, however, she did recall that ever since the very first programming session she was noted to have a high sensitivity and low side effect threshold. Over the last month, the patient had worsening head tremor and also had an electrical shock painful sensation when she tapped her scalp over the parietal connectors on the left side. This seemed to indicate a break in the insulation that was experienced when the lead was stressed. They would probably need to replace this lead to resolve the issue. X-rays were done to see if there was a disconnection or obvious circuitry probable over the left connector. Even if the x-rays were normal, they may benefit to revising the connection leads to insulate them better to see if this can avoid the electrical phenomenon. This would not be like ly to effect her tremor control or side effect stimulation thresholds. There was a skull x-ray showing the area that the surgeon was concerned about. It was on the left side, which matched where the patient felt the shocks, but it was a more frontal location than the surgeon was expecting. Coiling could be seen very faintly if zoomed in on the lead pictures. When they ran impedances initially on the left at the default 0. 7 volts, they had out of range impedances. Then they re-ran the impedances at 1. 5 volts and the impedances were in range. This made the hcp think that there was either an intermittent issue or the impedances were greater than 10000 ohms. Impedance testing did not reveal any major abnormalities. There were two contacts with a high impedance on the left that returned to normal impedance when tested at a 1. 5 volt testing threshold, which would indicate a normal impedance profile. The patient's scalp incision sites were clean, dry, and intact. She appeared to have a duel extension lead tunnel to the left. There was an implantable pulse generator (ipg) in the left intraclavicular position with a small amount of swelling with no erythema or tenderness. However, she had tenderness and a pulse-like shock sensation when tapped over the connector sites. This sensation disappeared when the device was turned off and it was present when the right or the left side was activated. The right side case was positive, 9 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. The left side case was positive, 3 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. There was some testing of the 0, 1, and 2 contacts on the left side, all of which produced unacceptable paresthesia and/or motor drive thresholds. It was experimented with a pulse width increased to 90 but were only able to achieve 1. 5 volts at this pulse width without developing unacceptable motor drive side effects. This side was returned to pulse width of 60, amplitude to 1. 7 volts, and monopolar stimulation to the number 9 electrode. There were two problems being experienced by the patient. She had very low side effect thresholds with stimulation. This was not a new phenomenon and was present since the initial program ing. It was possible that she was developing some tolerance and tremor breakthrough, and since higher voltages are being required she was unable to tolerate these due to the low thresholds. This was most likely due to initial lead placement and cannot be easily co rrected. The second problems was a shock-like painful sensation. After follow-up with the rep, the patient had worsening of tremor and would have a revision. The date of the revision was not yet scheduled. No outcome or intervention was reported regarding this event. 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=4976727
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« Reply #140 on: September 07, 2015, 07:38:52 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 #141 on: September 07, 2015, 07:39:40 AM »

Model Number 37601
Device Problem High impedance
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 748251, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 748251, serial# (b)(4), product type: extension. Product id 64002, product type: adapter. Product id 3550-29, product type: accessory. (b)(4). Device evaluation: analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 23. 2 cm from the distal end. ¿ analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 47. 0 cm from the distal end. ¿ analysis of extensions (b)(4) and (b)(4) and the pocket adapter found no anomalies.

Event Description
The patient's physician reported the patient "felt electrifying pain near the implantable neurostimulator (ins) and toward poor in the right side. " it was noted this had occurred following an ins replacement with an ins and pocket adapter, though initially following the replacement "everything was ok. " the patient reported they felt increasing electrical pain in the area of the ins with the pain radiating into their arm following the replacement. Initial impedance testing performed after the implant of the ins and adapter found "normal" impedances. Impedance testing performed at the time of report found the impedances were "too high" to be measured. The patient's physician performed troubleshooting through a revision procedure as a result. First, the physician changed the patient's pocket adapter, with "no improvement of the impedances. " the physician then changed the patient's extensions ((b)(4) and (b)(4)), "but with the new extensions the impedances were not measureable, so the physician changed the new extensions ((b)(4) and (b)(4)) again with two new extensions. " the impedances for contacts 0 and 8 reportedly remained not measurable at that time. It was reported the second pair of replacement extensions remained implanted at the time of report and the patient was "well" and "got an effective therapy" from their device. The physician was to be followed-up with a week after initial report. A supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004520
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« Reply #142 on: September 07, 2015, 07:40:24 AM »

Model Number 37603
Event Date 07/29/2015
Event Type Injury
Event Description
The healthcare professional reported that patient experienced a sudden upper extremity weakness bilaterally and was being admitted to the hospital. This event occurred during product use and the indication for use was movement disorders. No outcome regarding this event was reported. Further follow- up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Please see manufacturer report #3004209178-2015-16134 for information on the patient's concomitant system.

Manufacturer Narrative
Concomitant medical products: 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# va05cbr, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va04smb, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5008038
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« Reply #143 on: September 19, 2015, 02:42:19 AM »

Model Number 7428
Event Date 08/11/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The consumer via a manufacturer representative reported that the patient was implanted on (b)(6) 2013 due to parkinson's disease. On (b)(6) 2015, the patient's limbs felt rigid and it was difficult for them to walk. The patient suspected that the implantable neurostimulator (ins) was shut down. The patient requested a reprogramming on (b)(6) 2015. No troubleshooting was done and the event cause was not determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5043176
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« Reply #144 on: September 19, 2015, 02:43:09 AM »

Model Number 37601
Event Date 07/01/2015
Event Type Malfunction
Event Description
The friends/family of the patient reported that the patient had felt shocking/jolting in the arm, left shoulder and head since implant ((b)(6) 2015). The indications for use (ifus) were essential tremor and movement disorders. Further follow-up is being conducted to obtain information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 64002, lot# n434139 , implanted: (b)(6) 2015, product type: adapter. Product id: 3387s-40, lot# v120700, implanted: (b)(6) 2008, product type: lead. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027535
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