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Author Topic: Deep brain stimulator - Seizures  (Read 49581 times)
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dennis100
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« Reply #90 on: March 29, 2014, 12:11:33 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # j0546569v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 3387-40, lot # j0546401v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 7436, serial # (b)(4), implanted: (b)(6) 2005, product type programmer, patient. (b)(4).

 
Event Description
It was reported that the patient had a loss of therapeutic effect. It was stated that the patient had deep brain stimulation (dbs) therapy for seizure control and had recently started having more seizures. It was further stated that the implantable neurostimulator (ins) was interrogated and was found to be off and, according to the device usage data, had been turned off for several months. It was stated that the ins was then turned on and the amplitude was turned down from 6. 5 volts to 3. 7 volts. It was noted that the patient¿s healthcare provider had not seen the patient in over a year. It was stated that the device had only been used for approximately 67 of the 485 days since the patient had last met with her healthcare provider. It was noted that the patient did not take care of her system, but the people at the assisted living home did. It was further noted that the patient was living at the assisted living home because she had ¿mental issues. ¿.

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dennis100
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« Reply #91 on: March 29, 2014, 12:13:30 AM »

Model Number 7428
Event Date 01/19/2014
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Concomitant medical products: product id 3391, serial# unnknown, implanted: 2013-(b)(6), product type lead. (b)(4).

 
Event Description
It was reported the patient had convulsions. It was noted the event required hospitalization. The patient was noted as being alive with no injury. Symptoms included fever and seizures. It was noted the patient¿s physicians were following up with the situation. The last follow up visit performed with the psychiatrist was done in (b)(6) 2013 and everything was okay. It was later reported the patient¿s stimulator had been off since (b)(6) 2013. It was noted this was an accidental switching off done by the physician. Until the day before the event the patient was fine. It was noted an mri had been planned but the results were not available yet. Follow up reported the patient underwent an mri exam and the results suggested an infection as consequence of sinusitis. The patient was under antibiotics and was being closely followed by the physicians. It was noted at the time the leads and stimulator were still implanted. Additional information reported the entire system was explanted (b)(6), 2014. It was noted the patient was still in the intensive care unit and was unconscious.

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dennis100
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« Reply #92 on: March 29, 2014, 12:15:38 AM »

Model Number 7428
Event Date 01/19/2014
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported the patient had an epileptic seizure (b)(6) 2014. It was noted this was a new illness, injury, or condition that was not related to the device or the procedure. It was noted the situation was evolving at the time and that the patient would see the physician in a couple of days. The severity of the event was noted as severe. The event resulted in in-patient hospitalization and prolonged existing hospitalization. It was a life threatening situation that resulted in permanent impairment of a body structure or a body function. It necessitated medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function. It was also noted it resulted in fetal distress, fetal death or a congenital abnormality or birth defect. It was noted as no serious adverse device effect. Additional information reported the patient was awake and able to spontaneously move their limbs. It was also confirmed there was no fetal distress, fetal death or a congenital abnormality or birth defect. It was not known at the time if the event resulted in permanent impairment. The leads and stimulator had been explanted and an infection was detected.

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dennis100
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« Reply #93 on: March 29, 2014, 12:21:16 AM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id 7482a51, serial# (b)(4), implanted: 2007 (b)(6); product type extension product id 3387-40, lot# j0427795v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0427795v, implanted: 2004 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7436, serial# (b)(4), implanted: 2004 (b)(6); product type programmer, patient. (b)(4). This device was being used in an clinical trial for the treatment of adult refractory epilepsy.

 
Event Description
It was initially reported that the patient had recently been having some seizures. The patient stated that the patient was a ¿study patient or lab rat if you will,¿ for epilepsy. The patient used to have 5 seizures per day and many grand mal seizures. It was reported that the patient¿s neurologist wanted to remove her implantable neurostimulator (ins), since it did not pass the ¿(b)(4) approval¿. It was noted that the patient needed to have a ¿recharge,¿ but the ins listed for the patient was not a rechargeable type. The patient was told they could have ¿two more charges and that was it. ¿ it was unclear what the patient meant by this. The patient had concerns about what was to happen to their therapy when the battery ran out. It was also noted that the patient ¿donated her memory and half of her right temporal lobe. ¿ the patient also request information on why the deep brain stimulator works so well for their seizures. It was later reported on the same date that the patient had memory loss. The patient stated that half of their right temporal lobe had been removed. The patient stated that during the ¿recharge¿ procedure, lead wires were put to their head and then plugged into the wall. It was noted that this procedure would not recharge the patient¿s implant, as their device was not rechargeable. Additional information received on (b)(6) 2013 reported that the patient had been having a few ¿b and c¿ seizures as of the last six months. The most recent seizure was a ¿c¿ seizure on the ¿(b)(6). ¿ it was unclear which month the patient was referring to. It was noted that the seizures were not as severe as the grand mal seizures they had previous to the deep brain stimulation (dbs) implant. The patient stated that the device had helped them ¿greatly¿ with their epilepsy. Further information received on the same day reported that the patient had ¿about five b or c¿ seizures in the past month. The patient thought that the implantable neurostimulator (ins) battery needed to be replaced because, they had the implant for a long time. The patient indicated that the device was helping with their epilepsy and they wanted the trial to continue. Additional information received on (b)(6) 2013 confirmed that the reported the ins device worked very well for the patient¿s seizures. The patient stated that their healthcare professional (hcp) wanted to take the device out but the patient did not want to have it taken out. Further information received on (b)(6) 2013 reported the patient¿s neurologist wanted to have the ins device removed because, ¿it¿s not working. ¿ the patient thought the ins was working, but the battery was dead but was unsure when it went dead. The patient¿s trial was over and the patient had been having more seizures which was noted as starting up again ¿years ago¿. It was reported that the patient never heard a ¿beep¿ which told them the ins was dead. The patient was told the study they were in had been shut down in was reported as not shut down but was clarified that is was not. Based on evaluations of the patient¿s seizure history over the course of the study (began in (b)(6) 2004), it was reported that their seizures have not improved with stimulation, even before her battery reached end-of-life (eol) and was the reason the hcp recommended explant for her. The hcp felt it was not ethical to continue having her undergo surgical battery replacements if she is not benefitting from the therapy. Additional information received on (b)(6) 2013 reported that the patient was diagnosed with epilepsy and had an increase in seizures since moving and thought the increase in seizures was related to stress. It was noted that the patient¿s current doctor wanted to remove the ins device. The patient did not want to have the dbs therapy removed as they thought it was helping them. It was reported, however, that their doctor was ¿not supporting of that¿. Further information received on (b)(6) 2013 reported that the patient wanted a replacement of the ins device as they felt it was effective in treating their seizures. However, the patient¿s hcp did not want to implant a new one. It was noted that when the patient had a seizure, she had a movement beyond her control, so epilepsy was a ¿movement. ¿ if additional information is received, a follow up report will be sent.

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dennis100
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« Reply #94 on: April 10, 2014, 05:21:37 AM »

Model Number 3389S-40
Event Date 02/03/2014
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0dywx, implanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 37601, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator. (b)(4).

 
Event Description
It was reported that the patient seemed confused and not herself after her surgery on (b)(6) 2014. Patient had suffered from a seizure post-surgery. Patient was alive with no injury. Patient symptoms included altered mental status. It was noted that the patient had the generator and extensions implanted on (b)(6) 2014. Programming was to occur 3-4 weeks from the date of this report. Additional information received reported patient would not have initial programming for 3-4 weeks from the date of this report.

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« Reply #95 on: April 10, 2014, 05:22:31 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v499735, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v460686, implanted: (b)(6) 2010, product type: lead. (b)(4).

 
Event Description
It was reported that the patient had 10 ultra sound treatments beforehand and 2 weeks ago had 6 procedures. It was noted that the patient had a loss of therapeutic effect. It was noted that the reporter stated that with all the patient¿s medications the patient lost their balance all the time and fell frequently. It was noted that when the patient fell they did not hit their head and fell on their elbow and broke it. It was noted that the patient also had experienced changes in mental cognitive abilities. It was noted that again it was worse. It was noted that the patient had uncontrollable movements, and made spontaneous drastic movements, with their hands and sometimes hit the wall for furniture. It was noted that the patient had gone to the health care professional (hcp) and was referred for physical therapy. It was noted that the hcp was checking the device. Additional information received reported that the patient recently had an ultrasound and was not feeling well. It was noted that the ultrasound was five days ago and the patient had a convulsion like epilepsy and was shaking. It was noted that the patient had an ultrasound because of the parkinson¿s. It was noted that the patient had hit their elbow and the elbow had a bump so the patient was referred for ultrasound. It was noted that it was therapeutic ultra sound. It was noted that patient had had this before when the weather was changing and was thinking it was maybe the ultrasound procedure. Additional information has been requested, but it was not available as of the date of this report.

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dennis100
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« Reply #96 on: April 10, 2014, 09:40:08 PM »

Model Number 7428
Event Date 08/03/2004
Event Type  Malfunction   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
Product id 3387-40, lot# j0428349v, serial# implanted: 2004 (b)(6); product type lead product id 33 87-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead. (b)(4).

 
Event Description
It was reported the device was turned on at 5 volts for contacts 1, 2, 5, and 6 and the patient had an immediate ¿panic attack. ¿ the device was turned off and restarted fifteen minutes later at the same contacts but at 1 volt. Ten minutes later the patient had a generalized tonic-clonic seizure. The event was noted as ongoing. The event involved in-patient hospitalization. Intervention also included reprogramming. It was noted there was a torqued connection at number 7 revealed by x-rays that were taken to evaluate questionable impedance values. Review of post-operative films showed it occurred at implant. It was also noted that the stimulator was turned off by the patient. The patient had a temporary discontinuation of stimulation. The event was noted as resolved without sequelae.

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dennis100
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« Reply #97 on: June 07, 2014, 11:11:49 AM »

Model Number 37603
Event Date 04/30/2014
Event Type Injury Patient Outcome Hospitalization,Other
Event Description
It was reported the patient had gone to the office the day prior to report for a reprogramming session. It was stated no programming had been done yet but the patient had a seizure or stroke in the office. It was stated they did not know if it was related to the device and it was unknown if the patient had a history of stroke or seizure. It was noted the patient was admitted to the hospital and the patient status was unknown. It was further reported the cause of the issue was not determined. It was noted the patient was currently hospitalized.

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dennis100
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« Reply #98 on: June 08, 2014, 01:44:12 PM »

Model Number 7428
Event Date 10/01/2013
Event Type Injury Patient Outcome Other Event Description
Rieu, i. , kombo, m. A. , thobois, s. , derost, p. , pollak, p. , xie, j. , pereira, b. , vidailhet, m. , burbaud, p. , lefaucheur, j. P. , lemaire, j. J. , mertens, p. , chabardes, s. , broussolle, e. , durif, f. Motor cortex stimulation does not improve dystonia secondary to a focal basal ganglia lesion. Neurology. 2014;82:156¿162. Summary: to assess the efficacy of epidural motor cortex stimulation (mcs) on dystonia, spasticity, pain, and quality of life in patients with dystonia secondary to a focal basal ganglia (bg) lesion. In this double-blind, crossover, multicenter study, 5 patients with dystonia secondary to a focal bg lesion were included. Two quadripolar leads were implanted epidurally over the primary motor (m1) and premotor cortices, contralateral to the most dystonic side. The leads were placed parallel to the central sulcus. Only the posterior lead over m1 was activated in this study. The most lateral or medial contact of the lead (depending on whether the dystonia predominated in the upper or lower limb) was selected as the anode, and the other 3 as cathodes. One month postoperatively, patients were randomly assigned to on- or off-stimulation for 3 months each, with a 1-month washout between the 2 conditions. Voltage, frequency, and pulse width were fixed at 3. 8 v, 40 hz, and 60 ms, respectively. Evaluations of dystonia (burke-fahn-marsden scale), spasticity (ashworth score), pain intensity (visual analog scale), and quality of life (36-item short form health survey) were performed before surgery and after each period of stimulation. Burke-fahn-marsden scale, ashworth score, pain intensity, and quality of life were not statistically significantly modified by mcs. Bipolar epidural mcs failed to improve any clinical feature in dystonia secondary to a focal bg lesion. Reported event: one (b)(6) female patient with dystonia secondary to focal basal ganglia lesion had a focal epileptic seizure during the surgery. It was noted that the patient had no history of seizure and had no more seizures since the surgery. The source literature included the following device specifics: ins model 7428 and lead model 3587a further information has been requested; a supplemental report will be submitted if additional information is received.
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. 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 3587a, lot# unknown, product type: lead. (b)(4).

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« Reply #99 on: July 04, 2014, 09:03:59 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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« Reply #100 on: July 05, 2014, 12:17:17 AM »

Model Number 7426
Event Type Injury Patient Outcome Other
Event Description
It was reported the patient was getting ¿zapped¿ in their head at the time of report. It was stated it had been going on for 2 years prior to report. It was noted a few weeks prior the patient started to have seizures more often and they thought the device might have contributed to that. It was stated the patient fell more often and they were losing strength in their legs.
Manufacturer Narrative
Product id: 3387-40, lot# j0104141v, implanted: (b)(6) 2001, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. (b)(4).

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« Reply #101 on: July 05, 2014, 12:18:07 AM »

Model Number 7426
Event Type Injury Patient Outcome Hospitalization,Other
Event Description
It was reported that the patient had blacked out on monday prior to the date of this report. It was noted that the patient had episodes of dystonic seizures that lasted 45-50 seconds. It was further noted that the patient had blacked out a few times since monday prior to the date of this report. It was noted that someone at the hospital thought the right implant had a short. The patient would not get the device reset or checked for 2 weeks. The patient fell 2 months prior to the date of this report but they did not think this was related to the current incident. Patient¿s status was unknown. The patient was admitted to the hospital. It was later reported that the patient was ¿having seizures because of a faulty unit. ¿ this had started monday (b)(6) 2014. Therapy was not working as expected. There was a loss of therapeutic effect. Additional information received reported the patient was still having concerns with their device or therapy but was working with their doctor or manufacturing representative. The patient had an appointment on (b)(6) 2014. Reference manufacturer¿s report number: 3004209178-2014-09986.
Manufacturer Narrative
Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387, serial# (b)(4), implanted: (b)(6) 2007, product type: lead; product id 7438, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v805902, 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. (b)(4).

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« Reply #102 on: August 11, 2014, 11:12:14 AM »

Model Number 7428
Event Type Injury Patient Outcome Hospitalization,Other
Manufacturer Narrative
Concomitant medical products: 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. Product: id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2007, product type: lead. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2007, product type: lead. (b)(4).

Event Description
It was reported that the patient had been having a problem with seizures in (b)(6) 2014. The patient was in the hospital (b)(6) 2014. The implantable neurostimulator (ins) was turned off at that time because the healthcare professional thought that it could be impacting seizures. It was noted that turning the ins off had not taken care of the issue and had not appeared to be related. Stimulation was turned off in (b)(6) and had not been turned on because the patient had not been alert enough to answer if stimulation was helping and it was too much trouble to travel to turn the ins on and set up programming.

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« Reply #103 on: September 06, 2014, 12:53:49 AM »

Model Number 37603
Event Date 01/22/2014
Event Type Injury Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported that the patient experienced seizure like episodes. It was noted that the outcome was ongoing. It was noted that diagnostic methods included ct scan with contrast showing small amounts of blood around mid-portion of left dbs electrode. It was noted that the etiology was surgery/anesthesia. It was noted that the event was not related to the device or therapy. It was noted that the event was related to the implant procedure. It was noted that during the event the patient¿s armed flexed and began expressing gurgling sounds. It was noted that the ct reveled a small amount of blood around mid-portion of left dbs electrode in basal ganglia. It was noted that the severity was severe. It was noted that the event resulted in in-patient hospitalization. Additional information received reported that the seizure like episode occurred during the operating procedure. It was noted that the entire system was removed on (b)(6) 2014. Additional information received reported that the patient was having his system replaced when the event occurred. It was noted that the patient had not had the implantable neurostimulator (ins) placed yet. Additional information received reported acute hemorrhage around the left electrode. It was noted that after recovering the patient¿s implantable neurostimulator (ins) was implanted on (b)(6) 2014. It was noted that interventions included medical or non-surgical therapy including a regular textured diet. It was noted that the medical or non-surgical intervention was pharmacological. It was noted that eeg results were negative. It was noted that a ct scan with contrast showed that the patient was stable.
Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# vaobuyn, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# vaobuyn, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead. (b)(4).

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« Reply #104 on: September 06, 2014, 01:52:28 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Event Description
It was reported that the patient had had balance issues and trouble with speech since implant. It was noted that the patient had fallen a couple of times. Initially it was thought that the patient¿s medication was off but he had been off the medication and was still having problems. Patient had been instructed to turn stimulation down and had further programming appointment scheduled for the friday following the date of this report. Patient¿s stimulation was down from 3. 30 and 4. 10 to 3. 0 and 3. 40. Patient¿s status was unknown. It was later reported that there was disappointment and dissatisfaction expressed about the therapy as far as what had been sold and presented to them prior to implant and what had happened in reality. Patient had tremors prior to the deep brain stimulator implant. Patient had been pretested and it had worked for him. Almost 2 months after implant the patient had a lot of issues. Patient¿s quality of life had not increased. Patient had an appointment scheduled for (b)(6) 2014. Patient was experiencing symptoms. It was noted that the patient had expected it to be an outpatient surgery and instead patient had spent 10 days in rehab. The patient had been told about the risk of infection and stroke but nothing else. The patient had been trained on using the patient programmer but did not know what to do with it. The patient was not very discouraged and not positive. The patient was not enjoying things in life anymore. It was noted that prior to deep brain stimulator surgery the patient had only had some tremors and had not been that advanced with parkinson¿s disease symptoms. The deep brain stimulator surgery was supposed to make the patient better but had made him worse. Patient was not able to return to his physical job. Patient¿s symptoms were change in gait, lethargy, and seizures. It was further noted that the manufacturing representative had been there when the patient had a seizure and the representative had come to rehab. The patient had had a seizure right after surgery at the hospital on the date of implant. At rehab the patient had been completely out of it and had been unresponsive. The healthcare professionals were blaming it on medications. Patient was put on 4 different seizure medications, one being dilantin. Patient no longer took seizure medication. Patient was unresponsive and was sent for a computerized tomography scan (cat scan) which had determined the patient had seizures and that was when patient was put on seizure medications. The healthcare professionals had stated ¿oh no, he should be responsive. ¿ it was noted that nobody seemed to know what was going on. They had come for physical therapy and were not able to wake him up, he had been completely out of it. An electroencephalogram (eeg) was done and had not found anything particular. Following deep brain stimulator surgery patient had the following symptoms: speech issues, gait issues, balance problems, patient had fallen several times, extremely tired, swallowing issues, patient looked at food as if he did not know how to put a fork into it, and patient looked like he had aged (b)(6). Patient used to work full time, go to ymca 3 times a week and drove a car, patient was no longer able to drive or do anything. It was hard to leave the patient alone. It was believed that symptoms were device related because patient had no chemicals in his body except some medication for parkinson¿s and it was not a lot. Healthcare professionals stated they had never seen those symptoms after a deep brain stimulator surgery. Patient was told that this kind of reaction was very common and it might take 6 months to a year to recover from the surgery. Patient had been given a limit on the patient programmer and could not go beyond ¿4 or something. ¿ patient had been adjusting therapy all the time on his own. Patient got better here and there but still had a lot of issues going on and was no longer positive. Patient was scheduled to see the healthcare professional on friday following the date of this report. Additional information received reported the patient was having some gait and speech issues related to programming. Patient had primary tremor with parkinson¿s and as the patient would get tremor control he would get some speech issues. The patient had since been reprogrammed to a bipolar setting and although he had a little bit of a breakthrough tremor his balance was better and so was his speech the last time the manufacturing representative had spoken to the patient. It was unknown if there were any other updates. The manufacturing representative had been involved with the patient through rehab. It was noted that the patient¿s family was anxious about getting the patient¿s progress and getting him programmed so he could go back to work. As of the week prior to the date of this report the patient was doing better and was planning on returning to work. Additional information received reported the alleged seizure was not the reason for rehab and all of their patient¿s go through a rehab cycle. Seizure was not confirmed and had been discussed after the fact. The patient was having some cognitive issues after the battery placement that had led the healthcare professional to believe it may have been a seizure. Patient had been placed on seizure medication and had not had any seizure activity after the first alleged one. Additional information was requested but had not been received as of the date of this report.
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. 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: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jcu8, implanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979081
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« Reply #105 on: October 12, 2014, 12:49:52 PM »

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_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id n eu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension. (b)(4). Age at time of event: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. 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.

Event Description
Tolleson, c. , stroh, j. , ehrenfeld, j. , neimat, j. , konrad, p. , phibbs, f. The factors involved in deep brain stimulation infection: a large case series. Stereotactic and functional neurosurgery. 2014;92(4):227-233. Doi: 10. 1159/000362934. Summary: deep brain stimulation (dbs) is a proven treatment for various movement disorders resistant to medical management. Complications such as postsurgical infection can negate benefits and increase patient morbidity. We sought to better define risk factors for infection. We performed a review of dbs cases at our institution from january 1996 to june 2011. Information on multiple metrics including surgical complications, procedural complications and infection were entered into a secure online database. A total of 447 patients received dbs surgery. Twenty-six (5. 82%) developed infection sometime after dbs surgery with 9 (2. 01%) developing infection within 30 days after the final staged surgery. Operating surgeon (p = 0. 012), scalp erosion (p = 0. 0001), surgical incision opening time (0. 0001) and number of individuals in the operating room (0. 0027) were significant in the cumulative infection group. The 30-day infection rate was comparably low to other published studies. Several factors were noted to be significant in the cumulative infection group, but none in the 30-day infection group. Further understanding of infection risk factors is important to optimize patient selection and standardize infection-preventative techniques. Reported events: 1. 1 patient experienced a seizure. 2. 2 patients experienced intracranial hemorrhages. 3. 1 patient had a prolonged length of stay of 48 hours; it was noted that the normal stay was overnight. 4. 1 patient required multiple revisions. The reason for revision was not noted. 5. 2 patients experienced lead migration. 6. 2 patients experienced lead and implantable neurostimulator (ins) malfunction. 7. 1 patient experienced a small hemorrhage and bilateral pulmonary embolus. 8. 4 patients experienced the extension wire tethering/retunneling. 9. 26 patients developed infection after deep brain stimulation (dbs) surgery. It was noted that these 26 patients had a total of 38 discrete infection episodes. There were 8 patients who had repeat infections; 6 patients had two episodes of infection and 2 patients had four episodes of infection. The reporter stated that 9 patients had occurrence of infection within 30 days of surgery, 4 patients had occurrence of infection between 30 and 60 days, 2 patients had occurrence of infection between 60 and 90 days, and 11 patients had occurrence of infection after 90 days post-surgery. It was noted that cultures were taken for 30 of the infections. Reportedly, there were 12 staphylococcus aureus infections, 4 methicillin-resistant staphylococcus aureus infections, 4 enterobacter, 2 pseudomonas, 1 serratia, 2 staphylococcus coagulase-negative, 2 mixed and 3 no growth infections. The reporter stated that out of the 38 instances of infection, 1 infection received only antibiotics, 7 received antibiotics plus a surgical exploration of the wound, which would include a washout and/or moving of parts of the apparatus. Reportedly, 10 of the infections received antibiotics plus total removal of the hardware and another 3 received antibiotics plus removal of an entire side of the dbs apparatus when a dual channel was used. It was noted that the other 17 had local removal of hardware. Only 1 of the 8 patients with repeat infection had only antibiotics and a washout as the first intervention. 5 patients had infection of the scalp overlying the lead, 6 patients had infection overlying the extension, 6 patients had primary infection of the implantable neurostimulator (ins), 2 patients had infection of the lead/extension, 1 patient had infection of the ins/extension, 4 patients had infection of the entire apparatus, 1 patient had infection of the bony markers, and 1 patient had infection of the lead/opposite side ins. It was noted that there were 11 infections which had a primary infection involving the ins, of these infections 6 involved kinetra model 7428, 2 involved activa pc model 37601, and 3 involved soletra model 7426. 10. 1 patient had an intracerebral abscess. 11. 1 patient experienced cancer near the burr holes. The source literature included the following device specifics: the leads were model # 3387 or 3389, and extensions were model # 7495 or 7482a-s1. 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=4090384
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« Reply #106 on: October 13, 2014, 03:39:03 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had had seizure on two separate occasions post deep brain stimulator implant. Prior to the deep brain stimulator surgery the patient had never had a history of seizures. The first seizure had occurred on (b)(6) 2014 and the patient was taken to the hospital after the seizure where a computerized axial tomography scan (cat) was performed and nothing was found. The second seizure event occurred on (b)(6); the patient had a seizure and was taken to the hospital. While the patient was in the emergency room, she had another seizure when she had gotten up to walk to the restroom. The patient had smashed her face and broke her leg which had resulted in hospitalization and surgery on the leg. The patient was in physical therapy for two weeks. The patient is now on anti-seizure medication, keppra-anti which is an epileptic drug. It was noted that since the patient had started the drug she had not had another seizure. All seizure events had occurred while the deep brain stimulator was off, the patient had never been turned on. (b)(6) 2014 was the first time, the patient had stimulation turned on. The patient had unilateral implant on the left side for a right side tremor. Following programming on the date of this report there was no visible tremor and the deep brain stimulator was working fine. There was good tremor control. The patient was scheduled for a follow up appointment in two weeks from the date of this report.

Manufacturer Narrative
Concomitant medical products: 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: 3387s-40, lot# va0jfw2, implanted: (b)(6) 2014, product type: lead. (b)(4).

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« Reply #107 on: November 08, 2014, 08:21:06 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va07ll1, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

Event Description
It was reported that the device was never really effective. The patient had gone to their healthcare professionals in (b)(6) 2013 for programming and they had been unable to get the device programmed. The patient was told that it needed to heal. In (b)(6) 2013 the patient had gone back in for programming, stimulation was turned up high to try to program the device but when they had turned it up high the patient had had a seizure and fractured his back. The patient had had the seizure because the wire had come loose and was sitting on the part of the patient¿s brain that caused seizures. The patient¿s health has prevented the patient from going back for programming. The patient¿s hands shook and he was unable to pick stuff up. No outcome was provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4145010
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« Reply #108 on: January 04, 2015, 12:14:42 AM »

Model Number 37601
Event Type Injury
Event Description
Bucurenciu, i. , staack, a. M. , hubbard, i. , rona, s. , gharabaghi, a. , steinhoff, b. J. Coincidence of non-convulsive epileptic seizures and electrical stimulation of thalamic anterior nuclei in an epileptic patient. Clinical neurophysiology: official journal of the international federation of clinical neurophysiology. 1388;2014 sep 2. Doi: 10. 1016/j. Clinph. 2014. 08. 008. Summary: a recent randomized, prospective study showed that deep brain stimulation (dbs) of anterior thalamic nuclei (ant) reduced frequency and intensity of epileptic seizures in medically refractory partial seizures, including secondarily generalized seizures ((b)(4)). Stimulation-associated transient seizures have been reported up to now in two patients ((b)(4)). In none of these cases a detailed description of the epileptic syndromes, of the electro-clinical semiology of stimulation-associated seizures and of the exact time-correlation between ant-stimulation and seizures onset and duration was provided. Therefore, mechanisms behind the effects and even the causality remain unclear. A detailed analysis of such cases might establish whether stimulation-associated seizures depend on epileptic syndromes and/or on stimulation parameters, and might give insights into the mechanism of action of dbs. We report the first case where the ant-stimulation intervals were precisely resolved and demonstrate for the first time a coincidence between on-phases of stimulation and habitual epileptic seizures, strongly suggesting a causal relationship. Reported events: one (b)(6) female patient was implanted with bilateral deep brain stimulation (dbs) of the anterior thalamic nuclei (ant) to treat non-lesional, medically refractory epilepsy of unclear etiology. The reporter stated that mutism and avolition after onset of dbs were interpreted as disappointment of the patient, since her habitual tonic-dyscognitive seizures were not improved by ant-dbs. The patient¿s scalp-eegs were closely reanalyzed towards the end of 11 months of dbs. Retrospectively and prospectively, the on-phases of stimulation cycles could be regularly identified based on amplitude reductions of qrs-complexes in electrocardiograms. The morphology of habitual bilateral fronto-centro-temporal (sharp)-slow-wave discharges in eegs was unaffected by ant-dbs. It was noted that there was a time-correlation between on-phases of stimulation cycles and habitual subclinical seizures at stimulation equal or above 3v. Repetitive bursts of sharp-slow-waves occurred 12. 6 seconds after onset of ant-dbs, which was similar to the time needed for ant-dbs to affect neocortical temporal activity. Electrical activity ceased 21. 7 seconds after the end of stimulation-on phases. In the density-spectral-array of a long-term video-eeg, several regularly-occurring periods with dominant delta frequencies, corresponding to bilateral anterior (sharp)-slow-wave series, were identified during ant-stimulation phases. In video-eeg-recordings performed when the patient was reading aloud, eeg-discharges accompanied by interruption of reading flow were reproducibly documented during on-phases of stimulation cycles. Ant-dbs was discontinued at the patient¿s request. The source literature included the following device specifics: lead model 3389 and activa pc ins model 37601 further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about patient information and additional information regarding the reported events. The device was used for an off label indication as it was implanted to treat seizures. Concomitant: product id 3389, lot# unknown, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4219411
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« Reply #109 on: January 10, 2015, 12:46:29 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
This value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. 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: product id 3389, lot# unknown, product type lead. Product id 7428, product type implantable neurostimulator. Product id 7428, product type implantable neurostimulator. Product id 7428, product type implantable neurostimulator. Product id 3389, product type lead. Product id 7428, product type implantable neurostimulator. (b)(4).

Event Description
Chiou, s. M. , lin, y. C. , lu, m. K. , tsai, c. H. Bilateral subthalamic stimulation for advanced parkinson disease: early experience at an eastern center. Neurological sciences : official journal of the italian neurological society and of the italian society of clinical neurophysiology. 2014. Doi 10. 1007/s10072-014-2008-x summary: deep brain stimulation (dbs) of the subthalamic nucleus (stn) can improve the life quality of patients with advanced parkinson disease (pd). However, previous studies have stemmed mainly from (b)(6). Present study analyzed the 6-month outcomes of bilateral stn-dbs therapy that were observed during a 9-year period at a (b)(6). We retrospectively reviewed 72 consecutive patients, whose mean disease history was 8 years when they underwent surgery. The median ¿¿drug-off¿¿ hoehn and yahr stage was 3. The stn was targeted using t2-weighted magnetic resonance imaging and electrophysiological guidance. The over-time mean differences in the unified pd rating scale (updrs) scores and daily levodopa-equivalent dose (led) were assessed using the repeated measurements anova at 3 and 6 months relative to those of presurgical drug-off baseline. At 6 months postsurgery, the mean updrs total, part ii and part iii subscores significantly decreased by 27, 30 and 25 %, respectively, with clinically high effect size. Tremors were markedly (66 %) ameliorated. Moreover, problems of akinesia, rigidity, and locomotion were significantly improved by 20 %. The mean daily led needs decreased by 25 %; thus, drug-induced dyskinesia was markedly (80 %) diminished. Stn-dbs therapy could provide similarly effective impacts to eastern and western pd patients. Preoperative optimal selection of patients and postoperative delicate programming ensure a better surgical improvement. Reported events: two patient with deep brain stimulation (dbs) for parkinson¿s disease experienced a seizure the day after implantation. It was noted that the patient subsequently exhibited a smooth treatment course. Two patients with dbs for parkinson¿s disease had malpositioned right leads, which were relocated when the implantable neurostimulator (ins) was implanted. It was noted that the patients subsequently exhibited a smooth treatment course. Two patients with deep brain stimulation (dbs) for parkinson¿s disease experienced acute psychosis for 3-4 days. It was noted that the patients subsequently exhibited a smooth treatment course. One diabetic patient with dbs for parkinson¿s disease experienced fluid accumulation in the chest ins pocket within one week; therefore, the ins was removed immediately and re-implanted four months later. It was noted that the patient subsequently exhibited a smooth treatment course. The source literature included the following device specifics: lead model 3389 and kinetra ins model 7428 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=4376136
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« Reply #110 on: January 10, 2015, 12:47:22 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had been having massive headaches that triggered seizures. This had been going on for about two years and it was getting progressively worse. The patient was having an mri of the brain and cervical spine the day after this report. The patient¿s programmer was lost, but the patient stated their healthcare professional (hcp) had a device to turn the implantable neurostimulator (ins) off. 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 3708660, serial# (b)(4), implanted: 2014-(b)(6), product type extension. Product id 3387-40, lot# j0104141v, implanted: 2001-(b)(6), product type lead. Product id neu_ptm_prog, product type programmer, patient. (b)(4).

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« Reply #111 on: January 10, 2015, 12:48:15 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v081575, implanted: (b)(6) 2008, product type: lead. Product id: 3387s-40, lot# v081575, 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) 2008, product type: extension. (b)(4).

Event Description
It was reported 4 days after implant the patient had a seizure and stopped breathing. They were different than the ones he would have before when ¿he would swallow. ¿ the patient had two other seizures on (b)(6) 2014 and (b)(6) 2014. They would see ¿bright lights like fireworks¿ and the patient had fallen out of their bed as well. They were not sure how that happened since ¿their feet were where his head should have been and they did not know how he had gotten in such a small space. ¿.

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« Reply #112 on: January 10, 2015, 12:49:11 AM »

Model Number 7426
Event Date 10/12/2014
Event Type Injury
Event Description
It was reported that ¿every time¿ the patient¿s hippocampal implantable neurostimulator (ins) was turned on, the patient ¿had seizures. ¿ the patient had reportedly been seizure free ¿for a long time,¿ however, the patient¿s seizures had recently ¿come on strong after being exposed to electromagnetic interference¿ (emi). The emi (at a security screener gate) was reported to have turned the patient¿s ins on. This event had occurred on (b)(6) 2014. The ins was turned off following the event. The patient was ¿seizure free for four weeks until (b)(6) 2014 when they had seizures again and fell. ¿ as a result, the patient ¿had to go to the hospital for assistance. ¿ it was noted that at that time ¿they thought the patient was having a stroke. ¿ the patient ¿hadn¿t had another event since (b)(6) 2014 when the hospital reprogrammed the implant to be at 0 volts, so if it came back on accidentally, it would come back on at 0 volts. ¿ the patient reportedly experienced ¿anxiety around emi because of the event¿ and ¿wanted the implant removed for peace of mind. ¿ additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Please note, this device was used for an off label indication. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4362757
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« Reply #113 on: January 10, 2015, 03:53:17 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial# (b)(4), product type programmer, patient; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 3387s-40, lot# v130906, implanted: (b)(6) 2008, product type lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id 3387s-40, lot# v130906, implanted: (b)(6) 2008, product type lead. (b)(4).

Event Description
It was reported that the patient was having seizures and it was unknown why. They had not thought that the seizures were related to the deep brain stimulator therapy. The patient was not having ¿full blown¿ seizures, only partial seizures. The patient had been having these for the past 4-5 weeks prior to the date of this report. The patient¿s healthcare professional wanted to do an electroencephalography (eeg) to see if they could find the cause of the seizures. The patient had been in the emergency room on (b)(6) 2014 and again on monday and tuesday prior to the date of this report because he had not been feeling well. No intervention or 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=4334477
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« Reply #114 on: January 10, 2015, 05:25:10 AM »

Model Number 3387S-40
Event Type Injury
Event Description
It was reported the patient experienced a seizure approximately nine days after bilateral globus pallidus internus lead implants. There were no alleged product issues and no actions were required as a result of the event. The patient status at the time of this report was alive with no injury. 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# va0nfax, implanted: (b)(6) 2014, product type: lead. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318458
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« Reply #115 on: January 10, 2015, 08:43:14 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0313854v, implanted: (b)(6) 2003, 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. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387-40, lot# j0313854v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported the patient started having symptoms of dementia in (b)(6)¿ (b)(6) and the patient had two seizures in february that accelerated the dementia. The patient recently saw a healthcare professional (hcp), but they do not work with deep brain stimulation therapy. 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.

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« Reply #116 on: January 10, 2015, 08:43:56 AM »

Model Number 37601
Event Date 11/10/2014
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6) ; product type extension product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

Event Description
It was reported, the patient had a seizure monday night post operation and again on the day of this report. The patient had swelling and edema near the site of the contacts by one of the implanted leads. The implantable neurostimulator (ins) had not been programmed or turned on after implant. Impedances were run during the operation. A ct scan was done and the cause of the event was unknown. The patient was still in the hospital and the device was not on. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4298457
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dennis100
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« Reply #117 on: May 09, 2015, 02:44:05 AM »

Model Number 3387S-40
Event Type Injury
Event Description
It was reported that the patient¿s stage 2 procedure was cancelled due to him having a seizure the day prior. His leads were implanted one week prior and he was admitted to the hospital the monday prior to the report, where had another seizure. A ct scan came back normal and the patient did not have a history of seizures. He was evaluated by neurology and there was no permanent impairment. He was doing fine and scheduled for stage 2 surgery on (b)(6) 2015.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va0s7rt, implanted: (b)(6) 2015, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4702383
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dennis100
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« Reply #118 on: June 08, 2015, 06:10:47 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had a seven year history of parkinsonism complicated by high dose use of entacapone and levodopa. The patient's implant of the system in the subthalamic nucleus was complicated by right frontal hemorrhagic stroke with bi-frontal injury evident on ct. The stroke resulted in left sided paresis and cognitive dysfunction amplified by two seizures. The patient was treated at ucsf. The patient was doing well with isolated control of parkinsonism and their health care professional (hcp) was monitoring their cognition.

Manufacturer Narrative
Concomitant products: product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4755853
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dennis100
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« Reply #119 on: June 08, 2015, 06:11:26 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v010169, implanted: (b)(6) 2006, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v010169, implanted: (b)(6) 2006, product type lead; product id 37651, serial # (b)(4), product type recharger; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

Event Description
It was reported the patient had a seizure and was in a hospital in (b)(6). A manufacturing representative later reported the patient was back in the united states and they continued to have seizures. The patient¿s healthcare professional (hcp) had not determined if the implantable neurostimulator (ins) was contributing to the seizures. The patient was scheduled for an mri next week. The patient was receiving effective therapy at the time of this report. 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=4798705
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