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Author Topic: Deep brain stimulator - Misc. Adverse Events  (Read 105340 times)
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dennis100
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« Reply #270 on: May 13, 2014, 12:29:06 AM »

Model Number 7426
Event Type Injury Patient Outcome Other
Event Description
It was reported they ¿jerry-rigged¿ the device and they had to keep the patient in isolation due to ¿being under anesthesia for over 5 years because they had the wrong parts. ¿ it was noted the anesthesia had done something to the patient¿s brain and it took 6 months of recovering for the patient to be back to normal. Additional information received corrected that the patient was under anesthesia for over 5 hours and not 5 years.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3777469
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dennis100
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« Reply #271 on: June 07, 2014, 10:35:56 AM »

Model Number 37602
Event Date 05/07/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported the patient had complained of being shocked in the chest from the device and they had a pain that would run down the left side of their body and down their left leg. It was noted the device was explanted on the day of report. It was stated a different product was used and the issue was resolved. It was noted the patient status at the time of report was alive with no injury. It was noted the patient had a burning sensation at the device pocket at the right side implant.

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dennis100
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« Reply #272 on: June 07, 2014, 10:50:38 AM »

Model Number 37602
Event Type Injury Patient Outcome Hospitalization
Event Description
It was reported that the patient had a loss of therapeutic effect. The healthcare provider (hcp) stated that ¿the patient had a loss of stimulation on the right lead. ¿ the patient was having symptoms on the left side of his body and was hospitalized due to severe left hemisphere dystonia. The issue started ¿about ten days ago¿ and the patient had been hospitalized since (b)(6) 2014 due to the loss of stimulation. No falls or trauma had been reported. The implantable neurostimulator (ins) showed that it had been on 100% of the time and ¿settings were working fine,¿ but a high impedance was seen on unipolar 0. However, the patient was not programmed using 0. The hcp tried taking impedances when the patient was in different positions, but they were not catching it not working. The hcp did not suspect an ins problem, but more of a lead problem. The hcp noted the left side impedances were fine. The hcp stated that a ct scan was performed and the lead looked roughly in place, but it was hard to tell. The ct scan did not show anything broken, but imaging was difficult since the patient was moving a lot. Further imaging was planned. Later that day it was reported that the patient could not move around for the last four days. The reporter stated that the patient was young and growing, so wondered if ¿things had moved. ¿ the reporter was going to meet with the patient and hcp and more imaging would be done. The reporter noted that the hcp could not replicate the high impedances on unipolar 0. The reporter stated that the patient may take days to react from the programming, so it was a difficult case. Further in the day it was reported that with the patient¿s head turned to the side there was no drastic change in the impedances. It was noted that the therapy change came very dramatically. The patient had not experienced any burning or shocking at any point. Two days later, it was reported that the hcp was planning to do a ct image the following day, but the reporter received no update. Additional information was requested, but was not available as of the date of this report. Refer to manufacturing report #3004209178-2014-09557 as the patient had a similar issue that resolved via lead replacement in 2011.

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dennis100
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« Reply #273 on: June 07, 2014, 10:50:59 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the patient¿s ¿cords¿ were too tight so at the revision on (b)(6) 2014 the healthcare professional (hcp) had tried to loosen them up in her neck but the hcp thought there was too much scar tissue and it had not helped. Patient was told they would assess this again in 3 months from the date of this report and at that time there may be a need to do another surgery to revise them.

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dennis100
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« Reply #274 on: June 07, 2014, 11:17:39 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported the patient had skin discoloration. It was stated they had been in the hospital for 5 days and no one could determine the cause of the red markings. It was stated the patient had gone through a surgical exploration to culture the battery and extension but found nothing. It was stated the patient experienced red marks along the length of the extension. It was stated the patient had no symptoms other than red marks on the skin. It was noted it was not itchy, not hot, and no fever was present. It was stated surgical intervention was required as an intervention. It was noted intra-operative cultures were taken to full-out infection. It was noted all of the cultures were negative. It was stated the patient status at the time of report was unobtainable. It was stated the patient had red marks on their skin at the extension location. It was further reported there was an infection. It was noted around (b)(6) 2014 the patient had started to show signs of infection. It was stated they had blotches on their skin. It was noted when they were hospitalized for 5 days no infection was found. It was stated since then the blotches had gone away. It was noted it was still ¿up in the air¿ to what had caused the blotches. It was stated the patient was going to see another doctor for a second opinion. Additional information received reported the patient was very satisfied with the therapy but was still concerned about the marks. It was noted nothing was explanted.

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dennis100
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« Reply #275 on: June 07, 2014, 11:18:52 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that there was a flipped battery. There was no alleged product issue. Action required as result of the event was a revision. The battery would be unflipped and sutured down better. No diagnostic testing or troubleshooting was required. Patient was alive with no injury. Patient symptoms associated with the event were unknown. Additional information received reported the cause of the flip was unknown. Revision surgery was performed. It was unknown how the patient was doing or if they were receiving therapy. Nothing was explanted. It was later reported that 2 months prior to (b)(6) 2014 the device flipped out of its place and the patient had to grab it and put it back in place. It was noted that the revision surgery was done on (b)(6) 2014. Additional information was requested but had not been received as of the date of this report.

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dennis100
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« Reply #276 on: July 04, 2014, 09:05:21 PM »

Model Number 37601
Event Type Injury Patient Outcome Disability,Required Intervention
Manufacturer Narrative
Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id 37601, lot# unknown, product type: implantable neurostimulator. (b)(4).
Event Description
Schmitt, f. C. , voges, j. , heinze, h. J. , zaehle, t. , holtkamp, m. , kowski, a. B. Safety and feasibility of nucleus accumbens stimulation in five patients with epilepsy. Journal of neurology. 2014. Doi: 10. 1007/s00415-014-7364-1. Summary: in five adult patients with intractable partial epilepsy, safety and feasibility of chronic bilateral electrical stimulation of the nucleus accumbens (nac) were assessed, also providing initial indications of therapeutic efficacy. Concurrent medication remained unchanged. In this phase 1 trial, clinical outcome parameters of interest were quality of life in epilepsy questionnaire (qolie-31-p), beck depression inventory, mini international neuropsychiatric interview, neuropsychological testing, and liverpool seizure severity scale. Those data were obtained after 6 months of nac stimulation and compared to the equivalent assessments made directly before implantation of electrodes. Additionally, monthly frequencies of simple partial seizures, complex partial seizures (cps), and generalised tonic¿clonic seizures (gtcs) were assessed during 3 months before electrode implantation and at the end of 6-month nac stimulation. Proportion of responders, i. E. C50 % reduction in frequency of disabling seizures (sum of cps and gtcs), was calculated. Main findings were unchanged psychiatric and neuropsychological assessment and a significant decrease in seizure severity (p = 0. 043). Qolie-31-p total score trended towards improvement (p = 0. 068). Two out of five participants were responders. The median reduction in frequency of disabling seizures was 37. 5 %. In summary,we provide initial evidence for safety and feasibility of chronic electrical stimulation of thenacin patients with intractable partial epilepsy, as indicated by largely unchanged neurocognitive function and psychiatric comorbidity. Even though our data are underpowered to reliably assess efficacy, the significant decrease in seizure severity provides an initial indication of antiictal efficacy of nac stimulation. This calls for larger and at best randomised trials to further elucidate efficacy of nac stimulation in patients with pharmacologically intractable epilepsy. Reported events: 3 patients with simple partial seizures (sps) had an increase in sps from. 27 in a 28 day period to. 50. An unknown number of patient¿s had a decrease in ¿cognitive speed¿ and ¿memory and learning functions¿ from 1 to. 97 and. 95 respectively. An unknown number of patients also had an increase in complex partial seizures from 1. 27 in a 28 day period to 2. 20; and an increase in disabling seizures from 3. 53 in a 28 day period to 3. 60. Additional information has been requested but was not available as of the date of this report.
Manufacturer Narrative
Attachments: article was not attached to the initial submission. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3874442
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dennis100
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« Reply #277 on: July 04, 2014, 09:06:01 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Event Description
Schmitt, f. C. , voges, j. , heinze, h. J. , zaehle, t. , holtkamp, m. , kowski, a. B. Safety and feasibility of nucleus accumbens stimulation in five patients with epilepsy. Journal of neurology. 2014. Doi: 10. 1007/s00415-014-7364-1 summary: in five adult patients with intractable partial epilepsy, safety and feasibility of chronic bilateral electrical stimulation of the nucleus accumbens (nac) were assessed, also providing initial indications of therapeutic efficacy. Concurrent medication remained unchanged. In this phase 1 trial, clinical outcome parameters of interest were quality of life in epilepsy questionnaire (qolie-31-p), beck depression inventory, mini international neuropsychiatric interview, neuropsychological testing, and liverpool seizure severity scale. Those data were obtained after 6 months of nac stimulation and compared to the equivalent assessments made directly before implantation of electrodes. Additionally, monthly frequencies of simple partial seizures, complex partial seizures (cps), and generalised tonic¿clonic seizures (gtcs) were assessed during 3 months before electrode implantation and at the end of 6-month nac stimulation. Proportion of responders, i. E. C50 % reduction in frequency of disabling seizures (sum of cps and gtcs), was calculated. Main findings were unchanged psychiatric and neuropsychological assessment and a significant decrease in seizure severity (p = 0. 043). Qolie-31-p total score trended towards improvement (p = 0. 068). Two out of five participants were responders. The median reduction in frequency of disabling seizures was 37. 5 %. In summary,we provide initial evidence for safety and feasibility of chronic electrical stimulation of the nacin patients with intractable partial epilepsy, as indicated by largely unchanged neurocognitive function and psychiatric comorbidity. Even though our data are underpowered to reliably assess efficacy, the significant decrease in seizure severity provides an initial indication of "antiictal" efficacy of nac stimulation. This calls for larger and at best randomised trials to further elucidate efficacy of nac stimulation in patients with pharmacologically intractable epilepsy. Reported event: a 53 year old female did not respond to stimulation of the nucleus accumbens. The patient also reportedly had an increase in total number of psychiatric conditions from 0 to 2; and included new onset generalized anxiety disorder after 6 months and major depression. Stimulation also had to be turned down in this patient due to an abrupt increase in seizure frequency. Additional information has been requested but was not available as of the date of this report.
Manufacturer Narrative
Concomitant product: product id 3387, lot# unknown, product type lead. (b)(4).

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dennis100
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« Reply #278 on: November 08, 2014, 02:00:42 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported 2-3 years prior to report the entire right side was taken out including the ins and lead wires. The doctor thought the patient had an allergy to nickel and they rejected the device. The patient rejected them. The patient went through almost a year of surgery to try to get the deep brain stimulator (dbs) therapy to work on the right side. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389s-40, lot# v563742, implanted: (b)(6) 2012, product type: lead. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2012. Product type: extension. Product id: 7438, serial# (b)(4), implanted: (b)(6) 2007, product type: programmer, patient. Product id: 3389s-40, lot# v010169, implanted: (b)(6) 2007, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. (b)(4).

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dennis100
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« Reply #279 on: November 08, 2014, 03:25:53 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_ext, serial# unknown, product type: extension. Product id: neu_unknown_prog, serial# unknown, product type: programmer, physician. (b)(4).

Event Description
It was reported that ten days after the implantable neurostimulator (ins) was implanted, it was taken out because it was defective. The patient was looking to have programming done every three months and possibly have another stimulator placed on the other side as well. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4167362
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dennis100
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« Reply #280 on: January 10, 2015, 08:15:12 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had been admitted to the hospital for "spells of involuntary posturing, convulsion," which started to occur 8 days ago. The issue had also happened 2-3 weeks prior to the report date. The patient felt a shock-like sensation and the physician was concerned about potential fracture of the deep brain stimulation (dbs) lead wires. X-rays were going to be performed to assess the integrity of the dbs system. An impedance test was performed with impedances ranging from 813 ohms to 3096 ohms on the left side and impedances ranging from 885 ohms to 1757 ohms on the right side. There were plans to do imaging with mri two days from now to look for potential tissue damage. It was noted the patient had access to increasing amplitude and voltage on the left side and right side of the implantable neurostimulator (ins). The patient could go as high as 6 volts on the left side and 5 volts on the right. The patient was currently programmed 0-, 3+ and 4-, 7+, but was to be reprogrammed 0-, 2+ on the left side to avoid contact #3 since its impedance value was 3096 ohms. The symptoms were reported to have occurred on the right side, and an attempt was made to see if palpation and if head positional changes would cause reoccurrence of symptoms. No outcome was provided with this event. Further follow up is being conducted to obtain this information. A follow up report will be sent if additional information is received.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7436, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4298508
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dennis100
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« Reply #281 on: January 10, 2015, 11:20:17 AM »

Model Number 37601
Event Date 02/19/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v639995, implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: lead. Product id: 37085-95, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37085-95, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported the patient had a dysfunctional stimulator. Examination revealed the patient had increased tremor. Intervention included explant and replacement of the stimulator and leads. The event was considered related to the device or therapy and not related to the implant procedure. The event was resolved without sequelae.

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dennis100
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« Reply #282 on: January 10, 2015, 11:20:53 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id: 3389, serial# unknown, product type: lead. Product id: neu_unknown_ext, serial# unknown, product type: extension. Product id: 64002, serial# unknown, product type: adapter. (b)(4).

Event Description
It was reported that the patient¿s implantable neurostimulator (ins) had drained prematurely to an elective replacement indicator (eri) status. The patient had been programmed to 3. 3v, 150 ¿s and 140 hz on channel 1 and 2. 6v, 120 ¿s and 140 hz on channel 2. Therapy impedances were 267 ohms and 967 ohms on the respective channels. Cycling was not enabled and electrode impedances were all within normal range. With this ins, therapy had not been quite as good as one of the patient¿s previous devices. Rerogramming had been attempted several times, but to no avail. The patient was reportedly still receiving therapy, but it was ¿diminished¿. Additionally, the patient was now feeling ¿fuzzy¿ in the head. Further troubleshooting had been planned. A replacement for (b)(6) 2014 was noted. However, it was also stated that a replacement would follow if ¿lead or extension or whatever¿ was damaged. It was stated the procedure was not scheduled yet. It was ultimately unclear if the patient¿s device had been replaced, but information suggested a surgical intervention was to occur. Additional information has been requested but was unavailable at the time of the report. A supplemental report will be made available when this information is received.

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« Reply #283 on: February 07, 2015, 06:27:00 AM »

Model Number 37601
Event Date 01/05/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37085-60, serial# (b)(4), product type: extension. Product id: 37085-60, serial# (b)(4), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# v484000, product type: lead. (b)(4).

Event Description
It was reported the patient had their battery replaced due to expected longevity, no therapy or product issues were noted. Following the replacement they checked the stimulator and were ¿getting the same results. ¿ the battery was okay but it said estimated replacement indicator (eri) and 2. 5 volts. The batteries in the programmer were taken out to reset the programmer but they still saw the eri. The programmer was returned because it would not interrogate. Analysis revealed the antenna jack was resoldered as a preventative measure. Later it was noted that during the replacement the physician removed the stimulator after doing a slight pocket revision and the depleted stimulator was accidentally put back in the pocket instead of the new stimulator. The event was related to the device or therapy and implant procedure. The patient underwent an additional surgery to replace the stimulator. Following replacement the event was considered resolved without sequelae.

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« Reply #284 on: February 07, 2015, 06:27:48 AM »

Model Number 37601
Event Date 12/07/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

Event Description
It was reported the patient felt a buzzing sensation at the right underarm. It started around 12 days prior to report. No falls or traumas were reported. The patient had good therapy with some tremor present. Palpation did not cause stimulation changes. The health care professional (hcp) could not elicit the buzzing sensation that the patient reported. Impedances for the case were higher than the bipoles and they were higher than the patient¿s last visit and those values were ¿normal¿. The bipoles were in normal range. The impedances for the case on the day of report were: c/0 6653, c/1 5888, c/2 6241, and c/3 6747 ohms on the left brain side. The patient didn¿t want to turn off the stimulation when the buzzing would occur because they had ¿significant symptoms that made it very challenging for them to do daily tasks. ¿ the right brain lead had normal impedances and no changes were made to that side. Additional information received reported x-rays were performed on (b)(6) 2014 that revealed a fracture on the left lead. The patient had been referred to the implanting surgeon for the purpose of revising the lead surgically. It was further reported the patient was in the process of scheduling the revision surgery. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4409343
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« Reply #285 on: February 07, 2015, 06:28:30 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387-40, lot# j0421698v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 3387-40, lot# j0421511v, implanted: (b)(6) 2004, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37752, serial# (b)(4), product type: recharger. (b)(4).

Event Description
It was reported that there was a shocking or jolting sensation. The patient¿s device had gotten disconnected when he had fallen and he would get a buzz or shock in his chest when he would adjust it. It was unknown when the fall was because he had fallen several times. It had been sometime in-between the implant and his replacement surgery. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4409062
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« Reply #286 on: February 07, 2015, 08:57:29 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had walked through a security device on the day of report and experienced some sort of reaction. The reaction caused her to ¿not feel good. ¿ 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 3387040, lot# v009174, implanted: (b)(6) 2007, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4394195
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« Reply #287 on: March 07, 2015, 04:04:55 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/24/2013
Event Type Injury
Manufacturer Narrative
Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. 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 patient information and additional information regarding the reported events. Concomitant product: product id neu_unknown_lead, lot # unknown, product type lead. (b)(4).

Event Description
(b)(4). Summary: (b)(6) has had parkinson¿s disease since she was (b)(6). Deeply unhappy as a result of her symptoms and the lack of effect from the medication, she chose to have deep brain stimulation surgery 10 years later. She reports on the stereotactic procedure, her initial euphoria and the variable experiences after his. How bionic does she feel now? reported events: one (b)(6) female patient underwent right side deep brain stimulation (dbs) for parkinson¿s disease in (b)(6) 2012. The patient experienced a pleasant relaxed feeling on the left side of the body immediately upon implantation. It was noted that this was due to local stimulation from among other things, the surgical fluid. Parkinson¿s disease symptoms reportedly disappeared for a short time. It was stated that the patient experienced initial euphoria following surgery. Six weeks after implant, the surgical fluid was reportedly reabsorbed, and the parkinson¿s disease symptoms returned. Stimulation was then started. Voltage was increased slightly every 4 to 6 weeks from 1. 7 to eventually 2. 2 volts. The patient stated that although the voltage was increased slightly every month, she noticed relatively little effect. The involuntary movements in the neck and shoulder had disappeared, but the patient was ¿rather stiff¿ and needed the same dose of medication as prior to surgery. Six months after the surgery, the patient felt more inhibited and unhappier than ever before. The patient was stiff and could only go about daily activities after great thought and very slowly at that. The patient stated ¿it was as if a harness was closing in¿ on her. The patient felt greatly disappointed. It was noted that the patient experienced hysteria and the parkinson¿s disease symptoms started ¿slowly taking hold¿ of the patient¿s body once more. The patient¿s health care provider (hcp) then decided to stimulate a slightly shallower contact on the electrode and to increase the voltage further at the same time. After two months, the patient had almost reached the maximum voltage of 3. 5 volts; this helped and gave the patient enough movement on the left side. Stimulation was reportedly keeping the patient¿s left side under reasonable control; however, the patient then required levodopa and benserazide to ¿slow down¿ parkinson¿s disease symptoms on the right side. Unfortunately, this led to overstimulation of the left side; the patient¿s left foot drop made walking almost impossible. Therefore, the patient¿s right side symptoms were investigated almost one year after implant. The patient was observed after 12 hours without any medication or stimulation. The patient stated that when stimulation was stopped, she became dizzy and felt strange tingling sensations in her head. The patient felt that her eyes were ¿vertically rather than horizontally aligned. ¿ an extreme tremor almost immediately developed in the left arm and leg, worse than ever before. The patient tried grabbing her left arm with her right and when she finally managed to do this, her entire body began to shake. The patient was then able to switch stimulation back on. The patient ¿limped out of the hospital with her left foot dragging on the floor,¿ but was reportedly happy. The patient¿s right side reportedly responded well to medication following the observation. 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=4527164
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« Reply #288 on: March 07, 2015, 04:05:39 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s previous system turned off the (b)(6) security door. The stimulator was turned off by the security door years prior to the date of this report. The device was replaced and it had not happened since. There was no issue with the current device. 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=4524668
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« Reply #289 on: March 07, 2015, 04:06:24 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Product id 3389s-40, lot# va0phqn, implanted: 2014 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension (b)(4).

Event Description
It was reported that the patient had had a noise, a loud buzzing in his head since 2-3 days post lead implant and prior to the implantable neurostimulator (ins) implant. The noise had not changed regardless of whether stimulation was on or off or with different programming of electrodes. The noise in the patient¿s head was daily and constant and was sometimes louder than other times. The loud constant buzzing was in the patient¿s head at the lead location. The patient had required medical intervention in the form of medication to treat the buzzing noise in his head. The medications were prescribed by his neurologist. Reprogramming was required. There was no alleged product issue. Diagnostic testing and troubleshooting had included impedance testing, reprogramming and a computerized tomography (ct) scan. No outcome was provided, further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4523941
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« Reply #290 on: April 19, 2015, 01:24:40 AM »

Model Number NEU_INS_STIMULATOR
Event Date 02/23/2015
Event Type Injury
Manufacturer Narrative
Concomitant: product id 3389, product type lead. Product id neu_unknown_ext, product type extension. Product id 3389, product type lead. Product id neu_unknown_ext, product type extension. (b)(4).

Event Description
It was reported that following the patient¿s implant procedure on (b)(6)-2015, he was not doing well and may die. The implantable neurostimulator (ins) and both leads were implanted at the procedure. The reporter noted that the case was flawless and the neurologist was there. The patient was a great candidate for the therapy and had great responses during implant. The healthcare provider (hcp) thought that when they were closing, heat may have damaged a blood vessel. The hcp did not think the patient¿s condition was related to the system. No further interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623099
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« Reply #291 on: April 19, 2015, 01:25:40 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3093-33, lot# va0qq37,implanted: (b)(6) 2015, product type: lead. Product id: 3708320, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3708320, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3093-33, lot# va0qq37, implanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
It was reported the patient never had therapeutic effect. The patient had a bowel movement whenever they urinated. Two days later, the patient¿s system was explanted due to infection. The patient was shaking and had chills, fever of 103 degrees, cellulitis at the pocket site, and drainage from the pocket site. The cause of the infection was thought to be the patient entering a hot tub when instructed not to. Following the explant, the patient still had a fever and elevated white blood cell count of twenty. Perioperative antibiotics were prescribed. Six days later, the patient was doing fine and the infection had resolved. Replacement was desired, but not yet scheduled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4585961
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« Reply #292 on: April 19, 2015, 01:26:31 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the patient¿s lead was implanted to deep causing severe brain damage. The reporter stated the patient¿s life was ruined and changed forever because of the mishap in surgery. The patient had a deep brain stimulation system on both sides of their brain. The first system was successful, but the second system was a ¿total mess. ¿ the patient looked like they had a massive stroke. 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: product id neu_unknown_lead, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4635003
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« Reply #293 on: May 09, 2015, 12:13:33 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v055604, implanted: (b)(6) 2008, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387s-40, lot# v063567, implanted: (b)(6) 2007, product type: lead; product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3387s-40, lot# v055604, implanted: (b)(6) 2008, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387s-40, lot# v063567, implanted: (b)(6) 2007, product type: lead. (b)(4).

Event Description
It was reported the patient fell in (b)(6) 2014 and had been really sick since. The patient had a bowel blockage from their parkinson¿s disease medications and was sick with diarrhea. During that time, the patient had fallen and broken a big bone in their left arm that required surgery eight weeks later. The patient was weak from being ill and they were off balance. After the surgery, the patient had physical and occupational therapy. The weekend prior to this report and the weekend before that, the patient had fallen. The patient fell when they were in a small bathroom and they lost their balance. There was no return of symptoms and the patient always had dyskinesias. The week prior to this report the patient had a kind of spasm almost like a seizure where they would jerk. After the last fall, the patient would convulse into a ball, their face would scrunch, and veins would bulge in their neck almost like an electrical shock. The patient was taken to the emergency room after the fall. X-rays and ¿stuff like that¿ were done and they found the fracture at c7. An appointment was scheduled with a surgeon on the day of this report and with their managing healthcare professional (hcp) on (b)(6) 2015. 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=4717941
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« Reply #294 on: May 09, 2015, 12:14:15 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 3389s-40, lot # v587361, implanted: (b)(6) 2011, product type lead; product id 3389s-40, lot # v568830, implanted: (b)(6) 2011, product type lead. (b)(4).

Event Description
It was reported that the patient¿s tremors were controlled and his horrible head jerking stopped, but he had no balance and was unable to stand alone. Following surgery he had complications of multiple blood clots in both lungs and legs. He could not pee, so he had to wear a catheter for nine months until he got an urologist to do prostate surgery. The patient¿s wife had to hold onto him when he transferred from his power chair to the toilet, bed, or shower and also when he used a walker. The reporter also wanted to know if the ¿shocking of the implant¿ could cause a sudden spin to the left and fall. At other times he also described his eyes crossing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4662438
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« Reply #295 on: May 09, 2015, 12:15:06 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had the deep brain stimulator surgery in (b)(6 prior to the date of this report, there was only a little bit of help and it was not worth the three bad months the caregiver went through. The patient wife was very disgusted. The patient only got maybe 30 minutes more a day when he could actually move. The reporter thought patients should be informed they will only get a little bit of help and to weigh that with the fact that the patient may have hallucinations and have rem sleep disorder problems after. 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.

Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator; product id 3389s-40, lot # va0g9lu, implanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-40, lot # va0gds4, implanted: (b)(6) 2014, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4654417
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« Reply #296 on: June 08, 2015, 06:38:02 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that there was a stimulation/therapy issue; the patient had a feeling of electrical current in his body during the recharging process. The patient also had tremor returning in his hands. The patient had had the device checked by an unknown physician but the problem had persisted. A surgical intervention was planned, the patient was going to undergo surgery on (b)(6) 2015 to diagnose the issue and possibly replace equipment. No outcome was reported, further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Product id 64001, lot# n460485, implanted: 2014 (b)(6); product type adapter product id 37642, serial# (b)(4); product type programmer, patient product id 37651, serial# (b)(4); product type recharger product id 3387s-40, lot# v821660, implanted: 2012 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4764867
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« Reply #297 on: June 08, 2015, 06:38:39 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that on 2014 (b)(6), the patient felt their ability to empty waxed and waned. On 2014 (b)(6), the patient had noticed more straining to void and decreased electrophysiological sensations. The health care provider (hcp) stressed that they did not have to feel anything specific as long as they were emptying well. The patient¿s post-void residual (pvr) had risen to between 120 and 160ccs and they were reprogrammed on 2014 (b)(6). Three days later, the patient¿s pvr was less than 100ccs and they were happy with this. The patient had a cystoscopy and endoscopy on 2014 (b)(6). The bladder was examined thoroughly and revealed some mild focal cystitis. Later the patient had an eroding sacral root pulse generator. The patient had run the gamut of more conservative therapy and ultimately it was elected to go ahead with explant on 2014 (b)(6). The area of erosion was visualized and an incision was made over the old implantable neurostimulator (ins) wound. The ins was disconnected in the appropriate fashion, as per the manufacturer. The wound was copiously irrigated with antibiotic solution and packed. The entire procedure was completed without complications. A new ins was implanted on 2014 (b)(6). No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Product id 37651, serial# (b)(4); product type recharger product id 37642, serial# (b)(4); product type programmer, patient product id 3093-33, lot# va09r0z, implanted: 2013 (b)(6); product type lead product id 3708320, serial# (b)(4), implanted: 2013 (b)(6), explanted: 2014 (b)(6); product type extension id 3093-33, lot# va091q9, implanted: 2013 (b)(6); product type lead. (b)(4). Device was used for an off label indication. The indication the device was used for was urinary control.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4765630
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« Reply #298 on: June 08, 2015, 06:39:13 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4774612
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« Reply #299 on: June 08, 2015, 06:39:54 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient was left in a nursing home, worse off. Prior to the patient getting the deep brain stimulator he could walk and talk but now he was confined to a hospital bed in a nursing home. The patient could barely feed himself. The patient had gone through the surgery wide awake ¿like a trooper. ¿ it had all gone downhill about 2 months after the deep brain stimulator surgery. The patient had good progress after the surgery for a week to a week and a half or two weeks. The patient was walking, talking, and doing exercises but after that the patient had become wheelchair bound and in a nursing home. The patient could not talk , walk or feed himself. The patient¿s system was checked two years prior to the date of this report. Patient¿s status was unknown. Reprogramming had been tried. The patient had been his healthcare professional¿s and still could not walk or talk.

Manufacturer Narrative

Event Description
It was later reported the patient had deep brain stimulator surgery 4 years prior to the date of this report and it had worked great for almost 2 years but then things had gone downhill fast. The patient could not text.

Manufacturer Narrative
Concomitant products: product id: neu_unknown_lead, serial# (b)(4), product type: lead. Product id: 3387s-40, lot# v626366, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762647
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