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Author Topic: Deep brain stimulator - Swallowing  (Read 13855 times)
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dennis100
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« on: November 09, 2013, 02:02:29 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury  
Patient Outcome  Other
Event Description
Journal reference: morgan jc, sthi kd. A single-blind trial of bilateral globus pallidus internus deep brain stimulation in medically refractory cervical dystonia. Curr neurol neurosci rep. 2008;8(4):279-280. The purpose of this study was to evaluate the efficacy and safety of bilateral gpi dbs in the treatment of medication-resistant cervical dystonia. This was a 1-year, multicenter, prospective, single-blind study of bilateral gpi dbs in 10 patients with medication-refractory cervical dystonia. Reportable event: one patient experienced dysphagia that persisted at 1 year. See mfg report 2182207200805918.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1168087
« Last Edit: September 19, 2015, 01:25:51 AM by dennis100 » Logged
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« Reply #1 on: November 09, 2013, 02:02:50 AM »

Model Number 3387
Device Problem Device remains implanted
Event Date 11/20/2006
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
The patient's wife called the manufacturer on 12/01/2006 to report the patient had product implanted in 2006. The system was then programmed on 11/20/2006. Subsequent to programming the patient experienced symptoms related to neurological deficit; speech and swallowing abilities reportedly were affected. The patient has also experienced heavy eyelids. The hcp was contacted and the patient was scheduled for follow-up on 12/05/2006. The physician advised the patient to turn off the devices prior to exam. The patient shut off the first ipg on 11/28/2006 and reportedly turned off the second ipg on 11/30/2006. The patient's spouse called the manufacturer the following day to ask how long it would take for the patient's speech to return. No report of device explantation. Additional information has been requested. A follow up report will be sent if additional information is received. See also mfr report number 2182207-2006-02428.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=800771
« Last Edit: September 19, 2015, 01:26:24 AM by dennis100 » Logged
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« Reply #2 on: November 09, 2013, 02:03:40 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury  
Patient Outcome  Other
Event Description
Journal reference: morgan jc, sthi kd. A single-blind trial of bilateral globus pallidus internus deep brain stimulation in medically refractory cervical dystonia. Curr neurol neurosci rep. 2008;8(4):279-280. The purpose of this study was to evaluate the efficacy and safety of bilateral gpi dbs in the treatment of medication-resistant cervical dystonia. This was a 1-year, multicenter, prospective, single-blind study of bilateral gpi dbs in 10 patients with medication-refractory cervical dystonia. Reportable event: two patients had mild difficulties with swallowing. See mfg report 2182207200805918.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1168090
« Last Edit: September 19, 2015, 01:27:47 AM by dennis100 » Logged
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« Reply #3 on: December 06, 2013, 12:20:26 PM »

Model Number 7428
Event Type  Injury  
Patient Outcome  Hospitalization
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id 3389, lot # unknown, product type lead; product id 3389, lot # unknown, product type lead. (b)(4).

Event Description
Amtage, f. , lambeck, j. , rutsch, s. , prokop, t. , pinsker, m. , rijntjes, m. Behind the screen: pseudobulbar symptoms after deep brain stimulation. In: nikkhah g, pinsker m, eds. Stereotactic and functional neurosurgery. Vol 117: springer vienna; 2013:43-46. Summary: thalamotomy was formerly used to treat different tremor syndromes. Nowadays deep brain stimulation has become an established technique to treat different movement disorders. The combination of these two stereotactic interventions is rare. We present a patient which a right-sided tremor syndrome with and underlying pathology of combined essential tremor and parkinsonian tremor was successfully treated initially with bilateral deep brain stimulation in the subthalamic nucleus resulted in hemidystonia pathological laughing and crying, dysarthria and dysphagia, all due to dislocation of the stimulation electrode contacting the internal capsule. After discontinuation of the high-frequency stimulation these side-effects disappeared, but were then reactivated by an lcd television in stand-by mode. In this report we discuss the pathophysiology of pseudobulbar symptoms and pathological laughing and crying in context of thalamotomy and dislocated dbs electrodes. Furthermore, we report on the occurrence that magnetic fields in the household have an impact on deep brain stimulation, even if they are in stand-by mode. Reported event: one (b)(6) female patient with a history of right-sided tremor syndrome which was treated by a left-sided thalamotomy had a deep brain stimulation (dbs) implantable neurostimulator (ins) implanted in the subthalamic nucleus (stn) for her emerging parkinson¿s disease (pd). Postoperatively, the patient complained of slight dysarthria and dystonia in the right leg when using stimulation. Several years later, the patient reportedly displayed right-sided hemidystonia and aggravation of the dysarthria, in combination with pseudobulbar signs such as dysphagia and pathological laughing and crying (plc) when the amplitude was increased. Seven years after implant, the patient admitted herself to the hospital and had a cranial ct scan taken. The ct scan revealed a dislocation of the left-sided electrode, leading to a stimulation of the medial parts of the internal capsule with the two uppermost contacts. The reporter stated that the right-sided electrode was placed in a pronounced dorsolateral position, stimulating the internal capsule at low amplitude at the second proximal contact. The reporter stated that testing of the remaining contacts for therapeutic effect reportedly showed no benefit to the pd symptoms. The ins was then switched off and the dysarthria, dysphagia, plc and right-sided hemidystonia disappeared completely; the patient was then discharged from the hospital. The patient denied a revision of the electrodes, as she was experiencing well-being under medication. The reporter stated that the patient¿s pseudobulbar symptoms were due to dislocation of both dbs stimulation leads into the internal capsule and the hemidystonic syndrome was provoked by the high-frequency stimulation of the cortico-spinal tract within the left internal capsule. The reporter suggested that there was a concomitant vulnerability of the circuit due to the left-sided thalamotomy. The reporter stated that the left-sided thalamotomy was not able to provoke plc by itself, only additional high-frequency stimulation of the internal capsule resulted in plc and other pseudobulbar symptoms. It was noted that the right-sided stimulation of the internal capsule did not produce a clinically-apparent dystonia, but rather spasticity of the left leg, since stimulation of only a small amplitude was applied. The reporter stated that switching off the right-sided stimulation yielded no benefit with respect to the plc, suggesting that bilateral pathology was therefore not mandatory to provoke plc. One month later, the patient reported a reappearance of the pseudobulbar symptoms during housework. The patient reportedly presented with right-sided hemidystonia and showed identical pseudobulbar symptoms as previously, including dysarthria, dysphagia and plc. The reporter stated that an assessment of the ins revealed that the high-frequency stimulation was again provoking the symptoms. The patient stated that stimulation had not been restarted by herself or a physician. The patient stated that the symptoms had suddenly reappeared while leaning over the television screen, which was in stand-by mode. The reporter stated that the magnetic field of the television interfered with the stimulator and switched it on again. It was noted that the magnetic switch of the stimulator had not been inactivated and the amplitude of the left-sided stimulation parameters had not been set to zero when stimulation had been turned off. It was noted that the amplitude of the right stimulation contact was still set to zero. The reporter stated that after deactivating the stimulator, the pseudobulbar signs promptly disappeared again. 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=3466513
« Last Edit: September 19, 2015, 01:29:43 AM by dennis100 » Logged
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« Reply #4 on: December 06, 2013, 12:21:06 PM »

Model Number 7428
Event Date 10/17/2013
Event Type  Injury  
Patient Outcome  Hospitalization
Event Description
It was reported that the patient experienced a loss of therapeutic effect. It was noted that the patient had been in the hospital since (b)(6) 2013. It was further noted that the patient had a ¿parkinsonian episode on (b)(6) 2013, where the patient couldn¿t walk, swallow or eat and the patient had a drooping of the left side of her face and slurred speech. ¿ it was noted that the patient was taking her usual medications on that day, so they were unsure why the patient was having these symptoms. It was unclear what the status of the patient¿s stimulation was at that time. It was noted that this was a sudden change for the patient. It was noted that the patient had seen the physician within the month prior to the report and was doing fine. It was noted that they did tests and ruled out a stroke and all other testing that was done was negative. It was noted that ¿a short while after the patient arrived, the symptoms resolved and the patient returned to her usual baseline status. ¿ it was noted that the patient had not had any falls. It was not clear when the symptoms resolved. It was unknown if the stimulation had been turned off or if the patient¿s system was involved in any way.

Manufacturer Narrative
Concomitant medical products : product id: 3387-40, lot# v004533, implanted: (b)(6) 2006, product type: lead. Product id: 3387-40, lot# v004533, implanted: (b)(6) 2006, product type: lead. 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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3473120
« Last Edit: September 19, 2015, 01:31:04 AM by dennis100 » Logged
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« Reply #5 on: December 08, 2013, 04:44:54 AM »

Model Number 37601
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Product id 3387s-40, v515921, implanted: 2010 (b)(6); product type lead product id 3387s-40, v515921, implanted: 2010 (b)(6); product type lead product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6); product type extension. (b)(4).

Event Description
It was reported that with stimulation turned on images were distorted during a sleep study. Patient was having trouble swallowing and speaking. Sometimes her speech was very clear but as the day went on she gets tired and her voice gets softer and she couldn¿t annunciate. Patient did not have these issues before implantation. Issues started at the (b)(6) 2013. Patient¿s health care professional has not been able to make adjustments to help her speaking and swallowing issues. Speaking issues will come and go. The patient will be good for 1-1. 5 months after an adjustment and then their speech and swallowing issue would return. Patient had to eat very slowly. Patient had a barium swallow study done which showed food goes into her lungs. Patient could only eat food with a pudding like consistency. Patient said, she fell and continued to fall because she had balance problems. Adjustments to stimulation had been made to stop the falling issue. Falling issue had been fixed. Patient¿s health care professional wanted to do an mri to look at her device or therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3456405
« Last Edit: September 19, 2015, 01:32:31 AM by dennis100 » Logged
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« Reply #6 on: December 09, 2013, 05:27:24 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/24/2013
Event Type  Death   
Patient Outcome  Death
Manufacturer Narrative
(b)(4).

Manufacturer Narrative
The actual date of death was not provided. This date is based on the date of publication of the article. 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. Concomitant products: product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id 3387-40, lot# unknown, product type lead; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id 3387-40, lot# unknown, product type lead; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator. (b)(4).

Event Description
Li, d. , cao, c. , zhang, j. , zhan, s. , chen, s. , sun, b. Subthalamic nucleus deep brain stimulation for parkinson's disease: 8 yearsof follow-up. Translational neurodegeneration. 2013;2(1):11. Doi: 10. 1186/2047-9158-2-11. Summary: the short-term benefits of bilateral stimulation of the subthalamic nucleus (stn) in patients with advanced parkinson¿s disease (pd) are well documented, but long-term benefits are still uncertain. The aim of this study is to evaluate the outcome of 8 years of bilateral stn stimulation to pd patients. In this study, 31 consecutive pd patients were treated with bilateral stn stimulation. Their functional status was measured using the activities of daily living section of the unified parkinson¿s disease rating scale (updrs-adl) at drug on (with medication) and drug off (without medication) states preoperatively and at 1, 5, and 8 years postoperatively. In addition, levodopa equivalent doses and stimulation parameters were also assessed. After 8 years of stn stimulation, the updrs-adl scores were improved by 4% at drug off status (p > 0. 05) and 22% at drug on status (p <(><<)> 0. 05) compared with baseline; the levodopa daily doses were reduced by 28% = (p <(><<)> 0. 05) compared with baseline; the stimulation voltage and pulse width w ere not changed, but the stimulation frequency was decreased remarkably compared with the 5 years of follow-up. Adverse events were observed in 6 patients, including misplacement of the electrode and skin erosion requiring further surgery. All events were resolved without permanent sequelae. 2 patients died of aspiration pneumonia 6 and 7 years after surgery. The marked improvement in updrs-adl scores were still observed after 8 years of bilateral stn stimulation with medication. Reported events: two patients had skin erosion in pocket site. The stimulators were repositioned. All events were resolved without permanent sequelae. Four patients had malposition of the electrodes, which was revealed by ineffectiveness of stimulation and mri. The electrodes were adjusted to alleviate the symptoms. All events were resolved without permanent sequelae. One patient died of aspiration pneumonia due to swallow disorders 6 years after surgery. One patient died of aspiration pneumonia due to swallow disorders 7 years after surgery. Unidentified number of patients developed axial symptoms suchas swallow, speech and gait disorders. As a result, the stimulation was reduced further to improve balance and speech functions, especially in some bradykinesia or rigidity dominated patients. 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=3202457
« Last Edit: September 19, 2015, 01:34:10 AM by dennis100 » Logged
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« Reply #7 on: December 10, 2013, 07:15:07 AM »

Model Number 7426
Event Date 04/18/2012
Event Type  Death   
Patient Outcome  Death,Required Intervention
Manufacturer Narrative
 
Manufacturer Narrative
(b)(4).

Event Description
Additional information received reported that the heath care professional (hcp) never had seen seizure symptoms with device. It was unknown if the symptoms were related to the device, therapy, or advancement of parkinsons disease as the seizure-like symptoms were observed in the er setting. Hcp did not know cause of seizure-like symptoms or cause of patient death. No intervention was reported.

Event Description
Additional information received reported that the patient saw a physician on (b)(6) 2012. At that time, both devices were dead (eol - end of life) and couldn't read them. It had been over a year since the devices were last checked, as the patient had not seen the physician for over one year. On (b)(6) the physician sent a referral to get the patient's batteries replaced, but not sure if this was ever done. At that time, the patient was in a nursing home and doing poorly. The patient's death had not been reported to the physician's office. If additional information is received, a supplemental report will be filed.

Manufacturer Narrative
 
Manufacturer Narrative
Product id 748295 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ extension product id 748251 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ extension product id 7438 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ programmer, patient product id 3387-40 lot# v001105 serial# implanted: 2005-(b)(6) explanted: product typ lead product id 3387-40 lot# v001105 serial# implanted: 2005-(b)(6) explanted: product typ lead. Product id 7426 (b)(4) implanted 2009-(b)(6) explanted: product typ: neurostimulator. (b)(4).

Event Description
It was reported that the patient was having seizure activity. The patient was going to the emergency room for a ct scan. They did not bring the programmer to the er. Additional reporting noted seizure-like symptoms. Ct scan came back within normal limits. The patient was "admitted" to er. There was no known accident or incident related to this issue. The patient had not been seen by managing health care professional since 2008. If additional information is received, a follow up report will be sent.

Event Description
Additional information was reported that the patient had died. The cause of death was advanced parkinson's disease. The patient had trouble swallowing and eating and it got progressively worse. The patient chose not to have a feeding tube. The patient had a urinary tract infection about a week before he passed. The caller was able to turn off one internal neurostimulator (ins) but not the other ins. In (b)(6), an ins was replaced. About a month before replacement the patient had difficulty swallowing and lost therapeutic effect. The caller did not know when the ins depleted. Device information could not be obtained. 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=2563223
« Last Edit: September 19, 2015, 01:36:40 AM by dennis100 » Logged
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« Reply #8 on: December 10, 2013, 07:18:00 AM »

Model Number 7426
Event Type  Death  
Patient Outcome  Death,Hospitalization,Required Intervention
Event Description
Additional information stated that "there was no mention of the medical device being the cause of death in the death report. " no further information was available regarding the cause of death.

Manufacturer Narrative
 
Event Description
Additional information received reported that the patient had died. The reporter stated that the patient's death was 'indirectly' related to the stimulator. In (b)(6) 2012 the patient had an infection at the implantable neurostimulator (ins) site in the right chest area. It was stated that there was a 'little blue line that looked like a vein' on the patient's chest that appeared in early (b)(6). Then the line got 'much bigger. ' the patient was taken to the hospital and given intravenous (iv) antibiotics 'for a while,' then the doctor decided to remove the device due to infection by the end of (b)(6). When the battery was removed, 'it was such a shock to the patient's system that his mouth would not close,' and he could not eat. Nine days after surgery the patient was given a feeding tube. It was stated that the patient had pulled out his first two feeding tubes. The patient had difficulties with swallowing, and all of his food or drink was 'thickened. ' the third feeding tube was put in the patient's stomach. It was stated that a ct scan was performed in (b)(6). It was not clear if the scan showed anything. It was reported that around (b)(6) of 2012 ((b)(6) 2012) the patient had a brown-ish oozing fluid around his feeding tube. The home nurse was notified about the brown fluid, and stated that it was 'normal. ' on (b)(6) 2012 the patient had 'terrible stomach pain' and 'terrible leaking' at the site of the feeding tube. That patient was brought to the hospital on (b)(6) 2012. The doctors did discover a 'hole' in the patient's stomach. It was also noted that the week prior to going to the hospital the patient was in pain and he 'was not feeling good. ' there was an infection in the patient's stomach from the feeding tube. The patient died on (b)(6) 2012. No further information about the event was reported. Refer to manufacturer report #3004209178-2012-06182 for more information on the first infection and removal.

Manufacturer Narrative
(b)(4).

Manufacturer Narrative
Product id 7482a51, lot#, serial# (b)(4), implanted: 2012 (b)(6), explanted: product typ extension, product id 7438, lot#, serial# (b)(4), implanted: 2006 (b)(6), explanted: product typ programmer, patient product id 3387-40, lot# v000284, serial#, implanted: 2005 (b)(6), explanted: product typ lead. (b)(4).

Event Description
It was reported that, following a device replacement, the patient experienced cognitive changes. It was stated the patient's device was put at lower settings than their previous device. The patient then had an unrelated surgery, and was in a rehab facility. After that, the patient was reprogrammed, and his settings were increased slightly. After this visit, the patient was "thrashing" at his wife and daily helper he has had for six years. The patient was also pulling at his catheter and feeding tube. The reporter stated "this is how he gets if he's too medicated," but the patient's medication had not changed in "years. " 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=2671456
« Last Edit: September 19, 2015, 01:38:22 AM by dennis100 » Logged
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« Reply #9 on: December 10, 2013, 07:19:48 AM »

Model Number 7428
Device Problem Device or device fragments location unknown
Event Type  Death  
Patient Outcome  Death
Event Description
Pt's husband reports; in 2006, the pt passed away after prolonged troubleshooting during which time there was intermittent episodes of neurological impairment which the husband attributes to the activa dbs therapy. The pt was implanted with the dbs system in 2004. The pt reportedly had several neurological defecits immediately following, including obtundation, difficulty swallowing, paranoia, low voice volume and dementia which appeared to worsen when the therapy was on and would lessen when the therapy was off. The electrodes were eventually removed, however, the pt's condition continued to deteriorate. The pt eventually passed away at a nursing home while asleep. The mfr was unable to confirm the events, or the death, despite contact with doctor two different d a copy of the letter received from the pt's husband is attached. A follow up report will be sent if add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=752334
« Last Edit: September 19, 2015, 01:39:18 AM by dennis100 » Logged
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« Reply #10 on: December 10, 2013, 07:20:33 AM »

Model Number 37602
Event Type  Death   
Patient Outcome  Death,Required Intervention
Manufacturer Narrative
(b)(4).

Event Description
Additional information received reported that the patient was in hospice care and dying prior to the event and had not been receiving any therapeutic benefit from the implantable neurostimulator (ins). It was also noted that the patient had fallen at some point and that the device was checked to determine if it was working in an effort to keep the patient as comfortable as possible in their last days. It was during the device check that it was determined that there was a "break" in the ins system. It was reported that the increase in the patient's symptoms was the result of the fall that caused a "break" in the device system. It was also reported that the device did not contribute to the patient's death (no cause of death was reported). The neurologist then recommended that it be turned off and that the patient be made comfortable with medications. It was believed that the device system remained in the patient. If additional information is received, a follow up report will be sent.

Event Description
It was reported the device got an out of regulation (oor) message. Symptoms reported included that he could not move or swallow, was drooling, and had difficulty talking. The symptoms were present prior, but got worse 3 days prior to report. Three days later it was reported the patient was in hospice care and was not doing well. The patient had fallen. Upon interrogation of the device with a clinician programmer, a message read "delivered amplitude will be less than expected. " therapy measurement read "high. " three days later it was reported the patient passed away due to natural causes. It was reported that it was not related to the device that the reporter was aware of. Although death was attributed to natural causes, it is not clear if the device event, including loss of therapy, was related to the death.

Manufacturer Narrative
Product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 748251, serial# (b)(4), product type: extension. Product id 3387-40, lot# j0313910v, implanted: (b)(6) 2003, product type: lead. Product id 3387-40, lot# j0313910v. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2806465
« Last Edit: September 19, 2015, 01:40:23 AM by dennis100 » Logged
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« Reply #11 on: December 30, 2013, 07:30:21 AM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury  
Patient Outcome  Disability,Hospitalization
Event Description
Hcp reported right thalamic hemorrhage after dbs lead implant. Patient tolerated implant procedure well, however, postoperatively it was noted that the pt had some left-sided paralysis. Patient was unable to speak or form words, however, was able to vocalize. Patient also had left-sided facial droop. A post-op ct of the head was performed and it was noted that the patient had right thalamic and intracranial hemorrhage. Patient was evaluated by speech pathology and deemed high risk for aspiration due to oropharyngeal dysphagia. A dobbhoff tube was placed for nutrition, and the patient underwent physical and occupational therapy. Neurology exams and consult were obtained to evaluated the cause of the patient's hemorrhage. The results of the stroke workup were that the basal ganglia bleed was an unfortunate intraoperative event. Hcp felt there was no prophylactic intervention that could be undertaken to prevent a future bleed. At the time of discharge from the hospital, the patient was in stable condition, still had left side facial droop, difficulty swallowing and swelling in the lower left extremity. Patient was transferred to a rehabilitation facility. No report of device explantation due to the patient's condition it was felt that the implantation of the generator would be deferred until the patient was in better condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=658163
« Last Edit: September 19, 2015, 01:41:12 AM by dennis100 » Logged
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« Reply #12 on: January 03, 2014, 07:13:48 PM »

Model Number LEAD
Device Problem Device remains implanted
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Hcp reported patient experienced peri-electrode edema post surgery. Hcp reported patient was implatned in the subthalamus nucleus. Surgery was routine and uneventful. About 30 hours post surgery, the pt was behaving as if in off state; probably due to under treatment of l-dopa, however, correcting for this over the next couple of days did not change anything. The pt had low grade fever which resolved spontaneously and was not associated with leucocytosis or positive cultures in urine, sputum, or feces. Csf was normal with no white cells, and normal protein and glucose. The first ct scan appeared normal, apart from some frontal subdural air, elecrodes appeared well placed. The second ct scan revealed asymmetrical peri-electrode edema after 72 hours. The patient was treated with high doses of intravenous steroids (dexamethasone) and over the next few days the pt improved, more awake, more talkative, able to take some steps and occasionally able to swallow some food. Eleven days post implant the pt is not continuing to improve. The last ct scan showed worsening of the edema, although clinically the pt was unchanged. Hcp reported the leads were not exposed. One mer electrode was used on each side due to atrophy. There was some interference in the mer signal at the beginning of the first side from a poorly grounded monitor lead, but this resolved spontaneously. There is no evidence of infection. The pt seems to be improving rather than deteriorating with steroid therapy. Hcp reports there was no evidence of the inflammation in the csf; inflammatory response is of unknown origin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=814575
« Last Edit: September 19, 2015, 01:41:48 AM by dennis100 » Logged
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« Reply #13 on: January 03, 2014, 07:23:46 PM »

Model Number 7428
Device Problems Intermittent continuity; Explanted
Event Date 08/07/2006
Event Type  Malfunction  
Patient Outcome  Hospitalization
Event Description
European manufacturer representative reported loss of stimulation in a dystonia patient, with a severe return of symptoms. The device parameters reset to factory settings. Device interrogation showed battery capacity was 45-90 percent used. Impedances were good. The hcp reported the patient felt a severe return of dystonic symptoms. The patient's programmer showed the battery was good and the stimulator was on. The patient could not change the amplitude and called the physician. The physician asked the patient to come to the clinic as soon as possible. The patient visited the out-patient service office that same evening. After re-activation of the stimulator, the patient was scheduled for replacement surgery. The device parameters reset to factory settings again the next day with subsequent return of symptoms. Severe problems with swallowing made parenteral administration of water and sugar necessary. After exchange of the device, the therapy effect returned. The device was returned to the manufacturer for analysis. A follow up report will be sent when additional information is received.

Manufacturer Narrative
H6: preliminary device analysis was not available on the date of this report. A follow up report will be sent when device analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=779134
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« Reply #14 on: January 05, 2014, 02:17:35 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Journal reference: slowinski, et al. "unilateral deep brain stimulation of the subthalamic nucleus for parkinson disease. " j neurosurg, 2007, 106:626-632. Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each pt, the devices used and the complications experienced was not provided. It is possible that each pt may have experienced one or more than one complication. See scanned pages.

Event Description
Journal reference: slowinski, et al. "unilateral deep brain stimulation of the subthalamic nucleus for parkinson disease. " j neurosurg, 2007, 106:626-632. The article describes the results from a study that involved a series of 24 pts being treated with unilateral deep drain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. Five pts received bilateral dbs systems during the study period. A number of pt side effects were noted during the study. Reportable events: six pts (lead n=6) experienced stimulation related side effects (confusion, difficult swallowing, double vision) that were resolved with parameter adjustments without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959262
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« Reply #15 on: January 08, 2014, 04:25:35 PM »

Event Type  No Answer Provided  
Event Description
Journal reference: anderson, v. C. , et al. "pallidal vs. Subthalamic nucleus disease stimulation in parkinson disease. " arch. Neurol. 2005; 62: 554-560. The article describes a randomized, blinded pilot comparison of the safety and efficacy of stn and gpi stimulation in 23 pts with advanced idiopathic parkinsons. The pts were implanted bilaterally with dbs lead (model 3382 or 3387) and neurostimulator (model itrel 2 or soletra). Reportable events: lead (n=2) - one female pt experienced unexplained severe pd progression after 6 months of dbs therapy. She was treated with antibiotics for recurrent utis. At 12 months she was severely badykinetic and rigid, unable to communicate and had difficult swallowing. Lead (n=2) - one pt experienced ischemic stroke with persistent neurologic deficit. Lead (n=2) - one pt experienced extracranial lead fracture after falling. Lead (n=2) - one pt experienced memory deficits, difficulty concentrating and apathetic mood within weeks of surgery that persisted throughout therapy. Lead (n=6) - three pts experienced delirium. Lead (n=4) - two pts experienced anxiety. Lead (n=2) - one pt had mild visual field defects. Lead (n=2) - one pt experienced hallucinations.

Manufacturer Narrative
This report is being filed under exemption.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921676
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« Reply #16 on: January 14, 2014, 10:02:00 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury  
Patient Outcome  Other
Event Description
Journal reference: morgan jc, sthi kd. A single-blind trial of bilateral globus pallidus internus deep brain stimulation in medically refractory cervical dystonia. Curr neurol neurosci rep. 2008;8(4):279-280. The purpose of this study was to evaluate the efficacy and safety of bilateral gpi dbs in the treatment of medication-resistant cervical dystonia. This was a 1-year, multicenter, prospective, single-blind study of bilateral gpi dbs in 10 patients with medication-refractory cervical dystonia. Reportable event: two patients had mild difficulties with swallowing. See mfg report 2182207200805918.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1168090
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« Reply #17 on: January 18, 2014, 02:48:34 PM »

Model Number 7428
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 04/17/2009
Event Type  Malfunction  
Manufacturer Narrative
 
Event Description
It was reported that the patient's speech problems were getting worse and the patient had pulling on their neck. The patient further reported a loss of efficacy and noted that her symptom had returned to pre-implant. The patient was having a difficult time with swallowing. The symptoms occurred after the patient went through airport security. Additional information received reported that the patient was seen and was fine. The patient was no longer having dystonia symptoms. The patient felt a tingly feeling when she tried to use a magnet with the physician's instruction, which must have turned the system on. The system was interrogated and impedances checked and all the parameters were normal. The device was on. It was felt the stimulator was turned off sometime during the patient's travelling.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1432913
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« Reply #18 on: January 20, 2014, 01:04:28 PM »

Model Number 7428
Device Problems Loss of power; Implant, reprogramming of
Event Type  Malfunction  
Event Description
It was reported that the pt experienced a loss of therapeutic effect and their jaw almost locked up and experienced speech and swallowing difficulties. Some of the pt's dystonia symptoms, specifically rigidity in their left hand returned. Add'l info rec'd reported that the pt's neurostimulator turned off and when power was restored, it was on an incorrect program. Reprogramming indicated that voltages had increased. Good results were observed with reprogramming. No injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478820
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« Reply #19 on: January 22, 2014, 08:55:26 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614528
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« Reply #20 on: January 26, 2014, 01:45:44 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death  
Patient Outcome  Death,Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.

Event Description
Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229
« Last Edit: September 19, 2015, 01:47:28 AM by dennis100 » Logged
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« Reply #21 on: January 27, 2014, 03:32:08 AM »

Model Number 7428
Event Type  Injury  
Patient Outcome  Disability
Event Description
It was reported that the patient was implanted on (b)(6) 2010 due to parkinson¿s disease. It was noted that after the operation the symptom was well controlled. The patient fell in (b)(6) 2013 and then had difficulty walking gradually. Patient was reprogrammed on (b)(6) 2013 and after the programming the symptom improved. One month later the patient appeared to have difficulty walking, swallowing and could not care for himself. Patient was now taking pills. Patient was told the ¿product could remain to use although the product used faster. ¿ additional information received reported the effect of programming was good but one month later the symptom existed. It was unobtainable as to whether any malfunctions were see or cause of issues determined. It was unobtainable whether interventions were taken or planned. Patient walking difficulty was aggravated, had difficulty swallowing, constipation and could not take care of himself.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3519346
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« Reply #22 on: April 10, 2014, 05:54:22 AM »

Model Number 37612
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v297034, implanted: (b)(6) 2009, product type: lead; product id 37601, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v222841, implanted: (b)(6) 2009, product type: lead; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37651, serial# (b)(4), product type: recharger; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead. (b)(4).

Event Description
It was reported that the patient had a globus pallidus lead hooked up the right clavicular rechargeable device and a subthalamic nucleus lead hooked up to the left clavicular primary cell device. The patient was seen due to routine programming. There was poor globus pallidus outcome. The globus pallidus therapy was turned off due to side effects. It was noted that the patient still needed to recharge if the device was off. It was noted that the subthalamic nucleus was fine with no issues. (b)(6) 2014 lfc (hcp): additional information received reported the cause of the event was a misplaced globus pallidus lead or right brain. The lead was not in target, the right globus pallidus was planned. Patient had a brain mri in (b)(6) 2013 that showed the lead on the right was misplaced. The subthalamic nucleus was reprogrammed to optimize therapy and globus pallidus was turned off, (b)(6) 2013. Signs and symptoms associated with the event were slurred speech, severe muscle spasms, imbalance, and swallowing problems. The patient had not required hospitalization. Patient outcome was serious injury/ illness, recovered without sequelae. The patient had bilateral subthalamic nucleus that were effective stimulation. Side effects resolved when turned off the right lead and reprogramming the subthalamic to optimize therapy results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3690537
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« Reply #23 on: September 06, 2014, 01:58:59 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 #24 on: October 12, 2014, 06:22:33 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v526048, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2011, product type: extension. (b)(4).

Event Description
It was reported that a patient was hospitalized for 6 months because her lungs/diaphragm stopped working. One was frozen and the other wasn¿t moving at all. After the patient had the deep brain stimulator (dbs) put in, she started having trouble swallowing, her voice changed, and she was choking all the time. While the patient was in the intensive care unit (icu) her dbs batteries went out. A couple of weeks after the battery went out, her throat started getting better- everyone said ¿you sound wonderful¿. The patient wondered ¿if the dbs affected her throat, could it also have affected her diaphragm¿. The patient was breathing out of the top 1-2 inches of her lungs. After about 3 minutes of standing, the patient would be gasping for air. She is on oxygen ¿24/7¿. The patient had organizing pneumonia and within 2 weeks it was ¿so acute¿. A biopsy was attempted, but it was unknown what the patient had, how she got it, or how to fix it and they haven¿t been able to help her at all. The patient¿s tremors were ¿so bad now¿. When the patient¿s dbs devices were put in, they were affecting her thoughts and she was having trouble saying the right words. When the patient would want to say (b)(6) it would come out (b)(6). When her thoughts would come out, they weren¿t organized. Since the batteries went dead, she can think and say the right words. No interventions or outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. A follow-up report will be submitted when more information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4096816
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« Reply #25 on: October 13, 2014, 01:52:00 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# j0120726v, implanted: (b)(6) 2001, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0333858v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported the patient had a loss of therapeutic effect. The patient did have benefit from the deep brain stimulator (dbs) after implant. They had an issue with their patient programmer back in (b)(6). The patient had been ¿inpatient¿ since the beginning of (b)(6). Prior to that, the patient was an inpatient at another hospital since early (b)(6). They wanted the dbs systems checked as the patient didn¿t seem to get any benefit from the systems at the time of report. Over the past 2-3 months, the patient had stopped ambulating and had a slow decline. They did not have any big falls and they were not aware of any falls. The patient had gotten really sick and had a urinary tract infection that started a couple of weeks prior to report. While they had been an inpatient at the current hospital, they had a dramatic decline with breathing and swallowing difficulties so that they had a percutaneous endoscopic gastrostomy (peg) tube and tracheostomy. Additional information received reported it was unknown if the patient had a 50% or greater symptom reduction. The cause of the event was not determined, it was not device related and no reprogramming was needed. An mri was performed. The patient had not recovered and their symptoms were still ongoing. 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=4078072
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« Reply #26 on: April 19, 2015, 02:56:49 AM »

Model Number 7426
Event Date 02/07/2015
Event Type Injury
Event Description
It was reported, the patient had a loss of efficacy starting saturday. The patient had some tremor issues during the day on monday that started to progress. By monday night, the patient was tremoring heavily and they were spasming. The patient went to the hospital monday night. At the hospital, the implantable neurostimulator (ins) was turned off. The patient had experienced issues swallowing. An electrocardiogram, ct, and chest x-ray was done and a stroke was ruled out. When the patient was taken home from the hospital their tremor was minimal at that point. No tremor was visible when the patient lied down, but tremor was visible with movement. Prior to monday the patient was fine and they were receiving effective therapy. The patient had no falls or trauma, but they had blacked out while on the couch before the tremors started. Stimulation was verified to be on at the time of this report. The patient¿s healthcare professional (hcp) checked their medication and then increased the medication. The patient was to be monitored for two weeks and then be reevaluated. 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. Refer to manufacturer report #3004209178-2015-04127.

Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2007 (b)(6); product type implantable neurostimulator product id 748266, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0219953v, implanted: 2002 (b)(6); product type lead product id 748266, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0124596v, implanted: 2002 (b)(6); product type lead product id neu_ptm_prog, serial# unknown; product type programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570286
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« Reply #27 on: May 09, 2015, 02:36:36 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient had started going downhill in (b)(6) 2014. The patient had started falling a lot in (b)(6) 2014 which was why the patient had to be put into a nursing home on (b)(6) 2015. It was noted that after one of the patient¿s falls onto the floor the patient was placed in a hospital but it was unknown when the patient was admitted or when the fall was. The patient was released from the hospital on (b)(6) 2015 and was then admitted to the nursing care facility. The patient had fallen through the shower door, by the shower and a couple of times by the bed. The healthcare professional had done x-rays and everything was fine. The patient had very low blood pressure and took medication to bring the blood pressure up. It was noted that there were also times where he got up right away and he should not be doing that. The patient was in a wheelchair and does not walk with his walker. Starting in (b)(6) 2014 the patient had also been having trouble swallowing anything. The patient coughed a lot when he ate and even when he drank water. One day the patient had coughed really badly for a quite a while. The patient¿s wife pureed the food for patient and added thickening for liquids. On (b)(6) 2015 they had done a swallowing/aspiration test and it was pretty bad. The patient might get a g-tube for feeding purposes. The patient¿s last battery had lasted from 2005 to 2011 and they thought this battery would last for 5 years. The patient¿s family thought the battery was getting low because the patient was having neurological and swallowing issues which were symptoms that the patient usually had when their battery was getting low. The family wanted the implantable neurostimulator (ins) checked before placing the g-tube. The healthcare professional was unsure if the patient was getting benefit from the deep brain stimulator. 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. Reference manufacturer¿s report number: 3004209178-2015-07114.

Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator. Product id: 3389s-40, lot# v010293, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 748295, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4684090
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« Reply #28 on: June 08, 2015, 06:16:07 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
It was reported the patient was going to have a revision to remove the left ¿probe¿ next thursday. The lead is being removed because the patient lost all ability to swallow and speak and they had been on a feeding tube for eight months. The reporter stated the lead was not in the wrong spot, but it just was not where the patient¿s healthcare professional (hcp) put them. A new lead was to be implanted about a month after the lead was removed. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802718
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dennis100
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« Reply #29 on: September 19, 2015, 03:10:23 AM »

Model Number 37602
Event Date 08/06/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. 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. Product id: 3389040, lot# v008653, implanted: (b)(6) 2006, product type: lead. (b)(4).

Event Description
A health care provider (hcp) reported an end of service (eos) error code was displayed. The right implantable neurostimulator (ins) said eos and the left ins was on and okay. The hcp stated the eos explained why the patient was leaning to their left more prominently. A day prior to this report, the patient was not swallowing as well. Usually the hcp checked the patient's inss every friday, but they were not there last friday and they were not sure if the ins were checked. The patient's indication for use is parkinson's dual and movement disorders. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5039417
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dennis100
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« Reply #30 on: September 19, 2015, 03:10:54 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type Injury
Patient Outcome Other
Event Description
Journal reference: morgan jc, sthi kd. A single-blind trial of bilateral globus pallidus internus deep brain stimulation in medically refractory cervical dystonia. Curr neurol neurosci rep. 2008;8(4):279-280. The purpose of this study was to evaluate the efficacy and safety of bilateral gpi dbs in the treatment of medication-resistant cervical dystonia. This was a 1-year, multicenter, prospective, single-blind study of bilateral gpi dbs in 10 patients with medication-refractory cervical dystonia. Reportable event: one patient experienced dysphagia that persisted at 1 year. See mfg report 2182207200805918.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1168088
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dennis100
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« Reply #31 on: September 19, 2015, 03:11:36 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/11/2010
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no additional info was available, additional info has been requested.

Event Description
Literature: blomstedt p, sandvik u, tisch s. Deep brain stimulation in the posterior subthalamic area in the treatment of essential tremor. Mov disord. Jul 30 2010; 25(10); 1350-1356. Summary: to evaluate the posterior subthalamic area (psa) as a target for deep brain stimulation (dbs) in the treatment of essential tremor (et). Twenty-one pts with et were included in this study from 2004-2007. The group consisted of seven women and 14 men; with a mean age of (b)(6) years. All pts were evaluated before and 1 year after surgery. Dbs in the psa resulted in a marked reduction of tremor. A marked microlesional effect was noticed in 83% of the pts on introduction of the electrode, and due to continued absence of tremor, the stimulation did not need to be started in 35% before discharge from the hospital. No pt had simultaneous stimulation of two ipsilateral electrodes. No severe or permanent complication occurred. No hemorrhages or infections were encountered in this series. Reportable event: four pts experienced mild dysphasia that regressed. These four received an additional ipsilateral electrode (two stn, one vim, and one psa) in the psa due to suspected sub-optimal positioning of the first electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888957
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dennis100
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« Reply #32 on: September 19, 2015, 03:12:07 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 07/08/2010
Event Type Injury
Patient Outcome Other
Event Description
Literature: gruber d, kuhn aa, shoenecker t, et al. Pallidal and thalamic deep brain stimulation in myoclonus-dystonia. Mov disord. Aug 15 2010; 25(11):1733-1743. Summary: the authors investigated short- and long term effects on motor function, cognition, affective state, and quality of life (qol) of gpi- and vim-dbs in myoclonus-dystonia (md). Ten md patients were evaluated pre- and post-surgery between 1997 and 2009. Both gpi- and vim-dbs are effective. There were fewer adverse, stimulation induced events with gpi-dbs in comparison with vim-dbs. There were 18 reversible stimulation-dependent adverse events (ae) in the vim group which resolved by adaptation of parameters; these include dysarthria, dysphagia, dysgeusia, worsening dystonia, headache, gait disturbance, dysaesthesias. There were 4 events experienced by the gpi group; these were nausea and phosphene. It was unclear which patients experienced which adverse event; however, no serious long-lasting stimulation-related ae's were observed. Reportable event: patient 8 of 10 received bilateral gpi and vim-electrodes; this patient experienced a reversible intracerebral hemorrhage less than or equal to 3 month's hemiparesis. The source literature did not specify which device models were used for the different patients. See literature article with mfr report# 3007566237201007967.

Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible, several events occurred in one patient. At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872749
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dennis100
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« Reply #33 on: September 19, 2015, 03:12:34 AM »

Model Number 37603
Event Date 07/24/2013
Event Type Injury
Patient Outcome Hospitalization,Life Threatening,Disability
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0935y, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
It was reported that the clinical diagnosis was intraparenchymal hematoma. It was noted that the event was related to the procedure. It was noted that a post-op ct showed 2x1 cm intraparenchymal hemorrhage along the electrode tract. It was noted that there was mild hemiparesis/motor apraxia, dysarthria, dysphagia, and speech apraxia. It was noted that there was in-patient hospitalization. It was noted that there was prolongation of existing hospitalization. It was noted that actions taken included occupational and speech therapy. It was noted that the event resolved with sequelae on (b)(6) 2013.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3919317
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dennis100
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« Reply #34 on: September 19, 2015, 03:13:01 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va090aq, implanted: (b)(6) 2013, product type: lead; product id 3389s-40, lot# va08ytx, implanted: (b)(6) 2013, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4565375
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