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Author Topic: Deep brain stimulator - Stroke  (Read 28574 times)
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dennis100
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« on: November 09, 2013, 02:18:50 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

 
Event Description

Journal reference: papavassiliou e, rau g, heath s, et al. Thalamic deep brain stimulation for essential tremor; relation of lead location to outcome. Neurosurgery. 2008; 62(suppl. 2): 1120-1130. Thalamic deep brain stimulation (dbs) is commonly used to treat essential tremor, but the optimal lead location within the thalamus has not been systematically evaluated. We examined the relation of lead location to clinical outcome in a series of essential tremor patients treated by thalamic dbs. Fifty-seven leads in patients were studied. Reportable event: in one patient the lead was not evaluated, due to the patient having a stroke 4 months after implantation. See mfg report #218220720087354.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1229682

« Last Edit: February 03, 2014, 02:45:42 AM by dennis100 » Logged
dennis100
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« Reply #1 on: November 09, 2013, 12:27:49 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description

During implant, the surgeon woke the pt up and told her to touch her nose with her right hand. The pt was unable to talk and tell the surgeon that she couldn't reach her nose; she couldn't move it. It was determined that the pt had a stroke on the operating table. The pt spent 4 days in the hospital following the stroke. The pt completed speech and physical therapy. The pt long term effects were that now she needed to write things down because she forgot and "cognitive things are hard". The pt was also depressed. The pt thought the surgery was going to change her life for the better, but it "ruined it".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1543921
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dennis100
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« Reply #2 on: December 06, 2013, 12:16:40 PM »

Model Number 7428
Event Date 11/07/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that the patient was implanted on (b)(6) 2013 with a deep brain stimulator. It was noted that during the hospitalization the patient had a cerebral infarction. The patient received an emergency treatment from the doctor and the patient¿s life was no longer in danger. The patient was then sent to a local hospital for treatment and recuperation. The doctor¿s opinion was that the patient had serious diabetes and a narrow neck vessel. The patient¿s brain was under long term hyperglycemia and ischemia situation. The blood vessels were very fragile. The cerebral infarction had happened after the operation. Both the doctor and the patient thought there was no problem with the product.

 
Manufacturer Narrative
Concomitant products: product id 7482-51, serial # (b)(4), product type extension; product id 7482-51, serial # (b)(4), product type extension; product id 3389s-40, lot # va097pq, product type lead; product id 3389s-40; lot # va0aaas; product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3487870
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dennis100
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« Reply #3 on: December 06, 2013, 12:17:32 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 64001, lot# n301003, implanted: (b)(6) 2012, product type: adapter; product id 3387s-40, lot# v591417, implanted: (b)(6) 2012, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389-40, lot# j0220169v, implanted: (b)(6) 2002, product type: lead; product id 7495-51, serial# (b)(4), implanted: (b)(6) 1999, product type: extension. (b)(4).

 
Event Description
The patient had a stroke and needs an mri. It was thought that the stroke was unrelated to the device. It was unknown when the stroke occurred. The company representative confirmed on (b)(6) 2013 that the left hemisphere has one gpi and one lead connected to the ins which was not activated with stimulation. The impedance measurements were greater than 40,000 ohms with all combinations, which disqualified him for an mri. The other side impedance measurements were greater than 2,000 ohms on all combinations except 0 and c which were within range. This side was only tested at 1. 5v and not tested to 3. 0v. No cause was determined. The patient had regular stroke management and the device was not touched. It was noted that no comments were made about the device not being effective and nothing has or will be explanted. Reference manufacturer report# 3004209178-2013-20751.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3467749
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dennis100
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« Reply #4 on: December 06, 2013, 12:18:11 PM »

Model Number 7426
Event Date 11/04/2008
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that a patient was told that ¿the electrode may be in the wrong place¿ since she had surgery in 2008 or 2009. It was stated that one doctor thought she had a stroke. It was noted that the area being stimulated ¿might be the wrong area,¿ thus the patient was going to have an mri to determine if that was the case. The patient reportedly never had a tremor before the surgery and ¿since she got the device put in her whole right side was affected but it was inconsistent. ¿ a supplemental report will be sent if any additional information is received.

 
Manufacturer Narrative
Concomitant products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2008, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v236672, implanted: (b)(4) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462533
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dennis100
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« Reply #5 on: December 07, 2013, 06:06:11 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
The patient had a stroke and needs an mri. It was thought that the stroke was unrelated to the device. It was unknown when the stroke occurred. The company representative confirmed on (b)(4) 2013 that the left hemisphere has one gpi and one lead connected to the ins which was not activated with stimulation. The impedance measurements were greater than 40,000 ohms with all combinations, which disqualified him for an mri. The other side impedance measurements were greater than 2,000 ohms on all combinations except 0 and c which were within range. This side was only tested at 1. 5v and not tested to 3. 0v. No cause was determined. The patient had regular stroke management and the device was not touched. It was noted that no comments were made about the device not being effective and nothing has or will be explanted.

 
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2008 (b)(6); product type implantable neurostimulator product id 64001 lot# n301003, implanted: 2012 (b)(6); product type adapter product id 3387s-40 lot# v591417, implanted: 2012 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 3389-40, lot# j0220169v, implanted: 2002 (b)(6); product type lead product id 7495-51, serial# (b)(4), implanted: 1999 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3455595

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dennis100
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« Reply #6 on: December 07, 2013, 06:06:48 AM »

Model Number 37603
Event Date 08/24/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that there was inflammation around the tip of the lead. It was reported that the patient presented to the er on 2013 (b)(6) with stroke like symptoms, right facial droop, difficulty speaking and weakness in the right leg. It was noted that explant was a required action. It was noted that multiple ct scans were performed between 2013 (b)(6) and 2013 (b)(6) and an mri was also performed. It was noted that the patient was doing well after the lead and battery were placed at the original implant. It was noted that upon examination of the ct it was noted that the patient had a well-defined area of hypo-density surrounding the end of the lead. It was noted that the health care professional (hcp) did not believe it was an infection. It was noted that the patient had come back several times with the same complaints and it was ultimately decided to take the system out. It was noted that the patient was implanted in the left ventral intermediate nucleus. It was noted that the patient was given plavix, antibiotics and steroids during the process of at least two other hospitalizations. It was noted that the hcps did not believe it was an infection and were examining t heir procedures.

 
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2013 (b)(6), explanted: 2013 (b)(6); product type extension product id 3389s-40 lot# va09s07, implanted: 2013 (b)(6), explanted: 2013 (b)(6); product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479243
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dennis100
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« Reply #7 on: December 07, 2013, 06:07:39 AM »

Model Number 3389S-40
Event Date 10/31/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that there was unexplained edema surrounding the lead. It was noted that an explant of the lead was planned for (b)(6) 2013. It was noted that the patient had one complete left deep brain stimulation system implanted last year. It was noted that the patient was then implanted with a lead on the right side. It was noted that approximately 1 to 2 weeks later the patient was presented to the er with seizures. It was noted that a ct of the lead noted a non-infectious swelling surrounding the end of the lead. It was noted that the surgeon was convinced that it was not an abscess or infection. It was noted that they were not certain if the issue was the product, procedure or patient related. It was noted that the lead was being removed. It was noted that the patient was hospitalized and the reporter was unsure of what medical intervention was done. It was noted that multiple ct scans were performed. Additional information received reported that the patient did not have seizures but had more symptoms that resembled a stroke.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479050
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dennis100
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« Reply #8 on: December 09, 2013, 05:11:53 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/10/2013
Event Type  Death   Patient Outcome  Death
Event Description
Weintraub, d. , duda, j. E. , carlson, k. , luo, p. , sagher, o. , stern, m. , follett, k. A. , reda, d. , weaver, f. A. Suicide ideation and behaviours after stn and gpi dbs surgery for parkinson's disease: results from a randomised, controlled trial. Journal of neurology, neurosurgery, and psychiatry. 2013;84(10):1113-1118. Summary: the risk of suicide behaviours post¿deep brain stimulation (dbs) surgery in parkinson¿s disease (pd) remains controversial. We assessed if suicide ideation and behaviours are more common in pd patients (1) randomised to dbs surgery versus best medical therapy (bmt); and (2) randomised to subthalamic nucleus (stn) versus globus pallidus interna (gpi) dbs surgery. In phase 1 of the (b)(4) study, 255 pd patients were randomised to dbs surgery (n=121) or 6 months of bmt (n=134). For phase 2, a total of 299 patients were randomised to stn (n=147) or gpi (n=152) dbs surgery. Patients were assessed serially with the unified parkinson¿s disease rating scale part i depression item, which queries for suicide ideation; additionally, both suicide behaviour adverse event data and proxy symptoms of increased suicide risk from the parkinson¿s disease questionnaire (pdq-39) and the short form health survey (sf-36) were collected. In phase 1, no suicide behaviours were reported, and new-onset suicide ideation was rare (1. 9% for dbs vs 0. 9% for bmt; fisher¿s exact p=0. 61). Proxy symptoms of relevance to suicide ideation were similar in the two groups. Rates of suicide ideation at 6 months were similar for patients randomised to stn versus gpi dbs (1. 5% vs 0. 7%; fisher¿s exact p=0. 61), but several proxy symptoms were worse in the stn group. Results from the randomised, controlled phase of a dbs surgery in pd patients do not support a direct association between dbs surgery and an increased risk for suicide ideation and behaviours. Reported event: one male patient with globus pallidus interna (gpi) deep brain stimulation (dbs) committed suicide 10 months post-surgery. This patient was originally randomized to the best medical therapy (bmt) group, but 3 months later was re-randomized into the gpi dbs group. On the first night following dbs surgery, the patient had experienced a left hemisphere cerebrovascular accident secondary to an intracranial hemorrhage lateral to the left dbs lead, with expressive aphasia and right-sided weakness. The patient was hospitalized for six weeks and experienced some memory problems, word finding difficulties, depressive symptoms and emotional lability. The patient was then started on an antidepressant. Approximately one month later, the patient¿s cognitive and psychiatric symptoms had improved. At the patient¿s six month study assessment, the patient¿s motor score in the on-medication/on-stimulation state had worsened from the baseline by five points. At the six month assessment, the patient also expressed worsening depressive symptoms and suicide ideation; the patient was then hospitalized psychiatrically for approximately one month and had an adjustment to antidepressant medication in addition to receiving psychosocial treatment. It was noted that the patient had felt much improved on discharge. The patient committed suicide four months later. The suicide was attributed to situational depression and overall physical decline, given the postoperative time course, self-reported financial hardships, and extensive medical complications postoperatively and stability of the dbs settings prior to the suicide. 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. Concomitant products: product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_lead, lot # unknown, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3397552
« Last Edit: February 03, 2014, 02:46:01 AM by dennis100 » Logged
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« Reply #9 on: December 09, 2013, 05:13:19 AM »

Model Number NEU_INS_STIMULATOR
Event Date 02/28/2011
Event Type  Death   Patient Outcome  Death
Event Description
Hwynn, n. , hass, c. J. , zeilman, p. Romrell, j. Dai, y. , wu,s. Foote,k. , subramony, s. H. , oyama, g. ,velez-lago,f. , fernandez,h. , resnick,a. , malaty,i. , okun,m. Steady or not following thalamic deep brain stimulation for essential tremor. J neurol. 2011;258(9):1643-1648. Doi 10. 1007/s00415-011-5986-0 summary: deep brain stimulation (dbs) has become an important option for medication-refractory essential tremor (et), but may contribute to worsened gait and falling. This study evaluates impaired gait in a cohort of patients treated with dbs with a retrospective review of et patients before and after dbs implantation. Factors examined included: age, duration of symptoms, pre-morbid gait difficulties/falls, fahn-tolosa-marin tremorrating scale (trs) scores at baseline, 6 months post-unilateral dbs implantation, and 6 or 12 months post-bilateral implantation. All implantations targeted the nucleus ventralis intermediate (vim). Thirty-eight patients (25 males, 13 females) were included. Twenty-five patients (65. 8%) underwent unilateral dbs implantation and 13 (34. 2%) bilateral. The mean age at surgery was 67. 1 years ± 11. 4 (range 34¿81). The mean disease duration was 31 years ± 18. 3 (range 6¿67). Fifty-eight percent of patients had worsened gait postoperatively. Seventy percent of patients with unilateral vim dbs experienced gait worsening while 55% of bilateral dbs patients experienced gait worsening. Patients with worsened gait post-dbs had higher baseline preoperative trs scores than those without worsened gait (43. 1 points ± 8. 4 vs. 33. 1 points ± 10. 1, p = 0. 002) (odds ratio 2. 5, p = 0. 02). Gait/balance may worsen following dbs for medication refractory et. Higher baseline trs score mayfactor into these issues, although a l arger prospective study will be required with a control population. The larger percentage of difficulties observed in unilateral versus bilateral cases likely reflected the bias to not proceed to second-sided surgery if gait/balance problems were encountered. Reported events: 1. 1 patient had postoperative dbs-unrelated death before clinic follow-up 2. 2 patients had postoperative infection resulting in leads surgically removed within 6 months post-dbs 3. 1 patient had ischemic stroke. 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. 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. Product id: 3387, 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_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: 3387, lot# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3229671
« Last Edit: February 03, 2014, 02:46:12 AM by dennis100 » Logged
dennis100
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« Reply #10 on: December 09, 2013, 05:14:19 AM »

Model Number 7426
Event Date 03/01/2013
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that the patient died on (b)(6) 2013. It was noted that the cause of death was that the patient had contracted blood clots along with his parkinson's and it caused a stroke. It was also noted that the death was not related to the device or therapy.

 
Manufacturer Narrative
Product id 7426, serial # (b)(4), implanted: (b)(6) 2006, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3389s-40, lot # v010290, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3389s-40, lot # v010290, implanted: (b)(6) 2006, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3100653
« Last Edit: February 03, 2014, 02:46:23 AM by dennis100 » Logged
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« Reply #11 on: December 10, 2013, 07:22:03 AM »

Model Number 7428
Event Date 04/15/2013
Event Type  Death   Patient Outcome  Death
Event Description
Torres, c. V. , sola, r. G. , pastor, j. , pedrosa, m. , navas, m. , garcía-navarrete, e. , ezquiaga, e. , garcía-camba, e. Long-term results of posteromedial hypothalamic deep brain stimulation for patients with resistant aggressiveness. Journal of neurosurgery. 2013;119(2):277-287. Doi: 10. 3171/2013. 4. Jns121639 summary: erethism describes severe cases of unprovoked aggressive behavior, usually associated with some degree of mental impairment and gross brain damage. The etiology can be epileptic, postencephalitic, or posttraumatic, or the condition can be caused by brain malformations or perinatal insults. Erethism is often refractory to medication, and patients must often be interned in institutions, where they are managed with major restraining measures. The hypothalamus is a crucial group of nuclei that coordinate behavioral and autonomic responses and play a central role in the control of aggressive behavior. Deep brain stimulation (dbs) of the posteromedial hypothalamus (pmh) has been proposed as a treatment for resistant erethism, although experience with this treatment around the world is scarce. The objective of this study was to examine the long-term outcome of pmh dbs in 6 patients with severe erethism treated at the authors¿ institution. Medical records of 6 patients treated with pmh dbs for intractable aggressiveness were reviewed. The therapeutic effect on behavior was assessed by the inventory for client and agency planning preoperatively and at the last follow-up visit. Two patients died during the follow-up period due to causes unrelated to the neurosurgical treatment. Five of 6 patients experienced a significant reduction in aggressiveness (the mean inventory for client and agency planning general aggressiveness score was -47 at baseline and -25 at the last follow-up; mean follow-up 3. 5 years). Similar responses were obtained with low- and high-frequency stimulation. In 4 cases, the patients¿ sleep patterns became more regular, and in 1 case, binge eating and polydipsia ceased. One of the 3 patients who had epilepsy noticed a 30% reduction in seizure frequency. Another patient experienced a marked sympathetic response with high frequency stimulation during the first stimulation trial, but this subsided when stimulation was set at low frequency. A worsening of a previous headache was noted by 1 patient. There were no other side effects. In this case series, 5 of 6 patients with pathological aggressiveness had a reduction of their outbursts of violence after pmh dbs, without significant adverse effects. Prospective controlled studies with a larger number of patients are needed to confirm these results. Reported event: a female patient died 6 months after surgery as a consequence of a stroke. 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. 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. Product id: 3389, lot# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3335291
« Last Edit: February 03, 2014, 02:46:33 AM by dennis100 » Logged
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« Reply #12 on: December 10, 2013, 07:22:32 AM »

Model Number 37601
Device Problem No Known Device Problem
Event Date 06/21/2011
Event Type  Death   Patient Outcome  Death
Event Description
On (b)(6) 2011, the pt suffered a stroke and subsequently passed away. The physician revealed that there was evidence on the mri of previous stroke and thus presumably the pt was at higher risk of stroke. The physician believes the procedure rather than the ins components caused the stroke.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2167192
« Last Edit: February 03, 2014, 02:46:43 AM by dennis100 » Logged
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« Reply #13 on: December 23, 2013, 02:34:56 AM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2007
Event Type  Death   Patient Outcome  Death
Event Description
The manufacturer representative reported placement of bilateral dbs system. Pt status post implant was initially fine with no complications noted. The patient presented to a hosp for treatment three to five days post implant and suffered a fatal stroke. The exact date the pt expired is unk. No report of lead explant has been received by the manufacturer. The representative provided the two leads implanted were from the same manufacturing lot number. The device has not been received by the manufacturer for analysis. No other information is available. Additional info has been requested from the physician. A follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=812851
« Last Edit: February 03, 2014, 02:46:55 AM by dennis100 » Logged
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« Reply #14 on: December 23, 2013, 02:36:28 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Event Description
The hcp report in 2006 the pt experienced a stroke the evening after surgery and is now experiencing worsening depression and suicidal thoughts. In 2006, the hcp reported the pt was attending out pt mental health sessions once per week and the severe depression had resolved. Additional info rec'd via dbs clinical adverse event reports dated for 5 days indicate the pt committed suicide secondary to depression. The most recent updated sae report indicates: the pt was a man with idiopathic parkinson's disease since 1983 that lived in an assisted living facility. He enrolled in the study in 2005 and had the dbs system implanted in 2005. The surgery proceeded well and without complication. However, the evening after his surgery, the pt developed acute mental status changes and right hemi paresis, with ct scan showing a hemorrhagic stroke centered in the left putamen and extending into the insular cortex. The pt ultimately largely recovered from the stroke, but had mild residual effects of dysarthria and mild cognitive impairment. His parkinsonian motor symptoms were substantially improved with dbs treatment. In 2006 the pt was seen for his six month follow up visit. During the visit, the pt expressed depression and suicidal thoughts. Psychiatry service was consulted and they recommended that the pt be admitted. The pt was hospitalized for 21 days. Treatment included antidepressant medication, as well as individual and group psychotherapy. The pt's deep brain stimulation settings were adjusted on day 3 of hospitalization in case stimulation was contributing to the pt's depression - although this was felt to be unlikely. Following treatment with antidepressant medication and psychotherapy, the pt's depression significantly improved and he was discharged to his assisted living facility. The pt continued to participate in the outpatient psychiatric treatment program for approx 43 days. Upon discharge, the pt's depression was assessed to be greatly improved and was attributed to situational issues, including financial stressors and coping with medical illness; the pt was instructed to follw up with psychiatric services closer to home. The pt was last seen at the outpatient eval and assessment sevice in 2006 and treated with ketoconazole cream and shampoo for a skin rash. Approx 2 months later, the study center was notified from the pt's assisted living facility that the pt was deceased and that he was found by a caregiver at 2:00 am with a bag over his head and a belt around the neck. The suicide appears to be due to situational depression and may also reflect progression of the pt's parkinson's disease. Give the stability of the dbs setting and the temporal course of the suicide, it seems improbable that the suicide is related to study-related procedures or treatment. Current medications at the time of the event were: sinemet 25/100, entacapone 200mg, sinemet 50/200, olanzapine 2. 5mg, trazodone 100mg, citalopgram 20mg, terazosin 2mg, omeprazole 20mg, sodium chloride 1gm, fludrocortisone 0. 1mg, senna 8. 6mg, oxybutynin 5mg, hydrocortisone cream, ducosate 250mg, bisacodyl 5mg, bodan pad, and ketoconazole 2% cream.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=794838
« Last Edit: February 03, 2014, 02:47:05 AM by dennis100 » Logged
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« Reply #15 on: January 03, 2014, 07:10:26 PM »

Device Problem Device remains implanted
Event Date 01/24/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Information received via a university hosp clinical study report indicates implantation of the dbs electrodes was uneventful in 2007, other than some pt sleepiness (somnolence) noted during the surgery. Post-operative ct scan did not show any evidence of hemorrhage or other complication. The partial dbs system placed in 2007 was reportedly a medtronic activa system. The physician reports the subject was not improved one day after the procedure and was kept in the hosp for three additional days over the course of which he improved, but had not attained his preoperative level of function as of the date of the report received five days later. A ct scan performed on 01/2007 revealed either swelling detected around the electrode, or an area of small infarct noted in the pt left basal ganglia. The physician investigator indicated the serious adverse event was likely related to the research procedures. No report has ben received by the manufacturer of device explant. Additional information was received twenty three days later from the hcp. The full dbs system has not yet been placed; only the leads were implanted on the date of event. Implantation of the ipg is anticipated next week and the final serial numbers for all products placed will be reported to the manufacturer at that time. A follow-up report will be sent when additional info becomes available. The hcp confirmed the previous report of pt symptom of sleepiness; additional symptoms reported by the hcp on 02/21/2007 included slurring of speech, difficulty finding words and the pt has reportedly been walking into walls. The hcp also reported recent confirmation from the clinic that the pt did suffer a post-operative stroke. The pt has been monitored in the hosp for five days and is currently receiving physical therapy. The pt's condition is improving daily, as reported by the spouse, but has not fully returned to pre-operative baseline. See mfr's report number 2182207-2007-00689.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=823902
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« Reply #16 on: January 03, 2014, 07:25:13 PM »

Model Number 7428
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
An er hcp reported the patient has increased tremors and stroke-like symptoms. The deep brain stimulation system was turned on a week ago. No report of device explantation. Additional information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=835871
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« Reply #17 on: January 05, 2014, 02:31:01 PM »

Model Number 3387
Device Problems Intermittent continuity; Device remains implanted; Implant, reprogramming of; Wire(s), breakage of; Suspect EMI
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
The patient reported in 2007, that his ins had been turning off and on for eight weeks; the patient had reported many falls at follow-up in the following month. The representative verified the battery status via patient programmer and redirected the patient to the hcp. The hcp reported the next month, that the patient had experienced severe balance problems prior to system placement and after dbs implant. The patient had also suffered a several myocardial infarction (date not provided), that required defibrillation five times and resulted in a partial break in the dbs lead wires. The patient then suffered a stroke subsequent to mi and an aicd system was placed. The partial lead break progressed to a complete wire fracture and the dbs system was reprogrammed from monopolar to bipolar settings to avoid interference with the aicd. The patient indicated that his dbs system had recently been turning off and on at his place of employment; the patient works with computers. The patient was deemed too much of a risk to attempt surgical revision because of his condition. Additional information has been requested. See mfr report #6000153-2007-02706.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902861
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« Reply #18 on: January 06, 2014, 09:13:33 PM »


Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: kenney, et al. "short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. " journal of neurosurgery; 2007, 106:621-625. The study describes the results of a retrospective analysis of adverse events in movement disorder pts treated with deep brain stimulation (dbs) at baylor college of medicine between 1995 and 2005 along with a comparison analysis of the medical literature. Reportable event: one pt experienced a transient ischemic attack (tia) during the intraopertive recording/electrode implant stage of the surgery. Treatment and outcome info was not provided.

 
Manufacturer Narrative
Journal reference: kenney, et al. "short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. " journal of neurosurgery; 2007, 106:621-625. 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 more than one complication. No medwatc form was received from the user facility. Therefore, info on the medwatch form 3500a was completed by medtronic with info from the article. See scanned pages.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=951335
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« Reply #19 on: January 08, 2014, 04:21:45 PM »

Model Number 3389
Device Problem Implant, removal of
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization,Disability
Manufacturer Narrative
See scanned pages.

 
Event Description
Journal reference: gan et al. "bilateral subthalamic nucleus stimulation in advanced parkinson's disease, three year follow-up", journal of neurology (2007) 254:99-106. The study objective is to assess the long-term efficacy and safety of chronic bilateral stimulation of the subthalamic nucleus (stn) in consecutive patients. The article describes results of a study involving patients being treated with bilateral -stn dbs for advanced parkinsons disease. Parkinsonian status was investigated postoperative, at 1 year and 3 year intervals. Both transient and long lasting complications were included in the article. During the dbs lead implant procedure, one patient experienced a left-sided intracerebral bleed resulting in a slight permanent aphasia. The implant was interrupted and had to be placed two months after the stroke.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=930535
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« Reply #20 on: January 08, 2014, 04:22:39 PM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Journal article reported the pt was diagnosed with parkinsons in 1992. The pt was scheduled for surgery in 2005. After a couple of delays, due to a heart attack and back problems, the pt finally underwent surgery around the end of 2005. Shortly after the surgery, the pt suffered a stroke, a possible side effect of the surgery. The pt survived the stroke and now feels the benefits of the therapy. Add'l info has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if add'l info is received. Refer to medwatch report # 6000153200702392.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=884268
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« Reply #21 on: January 08, 2014, 04:23:46 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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dennis100
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« Reply #22 on: January 09, 2014, 09:08:31 AM »

Device Problem Device remains implanted
Event Date 11/02/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The pt underwent deep brain stimulation implant; during stage one surgery in 2006, he suffered acute ischemia in the right frontal lobe, which was diagnosed as cva secondary to dbs implant. He had rehabilitation; the pt received physical and occupational therapy and returned to baseline except for slight weakness in his lower extremity, which had been attributed to cva. At follow-up with the hcp via phone on 1/9/2008, the pt's daughter reported that the pt had fallen in 2007, and subsequently experienced left hip pain with an inability to stand or walk. Exam at the emergency room had revealed a fractured left-hip five days prior. The pt was admitted to the hospital two days later for left-hip hemiarthroplasty and experienced prolonged hospitalization secondary to left-sided weakness. Post-operatively the pt was confused; the confusion had been attributed to treatment with morphine, which was discontinued. The pt had been transfused with two units of blood for a reported drop in hemoglobin (pertinent test results were not available). The following day, the pt had been discharged to a rehabilitation center and then to a nursing home.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002342
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« Reply #23 on: January 09, 2014, 05:16:20 PM »

Model Number 3387
Device Problems High impedance; Device remains implanted
Event Date 05/13/2008
Event Type  Malfunction 
Event Description
It was reported that the system was interrogated because the patient anticipated an mri exam "due to a possible strike. " findings revealed high impedance readings were obtained on all or some of the unipolar electrode pairs. There were no patient symptoms reported and no other issues were detected from the implanted system. No programming changes were noted. Additional information has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059971
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« Reply #24 on: January 09, 2014, 05:16:51 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported the patient experienced nausea and vomiting after cataract surgery. The patient was admitted to the hospital with "stroke-like symptoms". No other symptoms or outcome were provided. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059854
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« Reply #25 on: January 12, 2014, 05:17:46 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: d. Fontaine et al. "subthalamic nucleus stimulation using a fisher zd stereotactic frame mr-ct fusion guidance and preoperative orthogonal radiographs, in parkinson's disease" neurochirurgie 53 (2007) 463-469. The article describes the method and results of a technique to implant electrodes in the stn for treatment of pts with idiopathic parkinson's disease. Sixty (60) pts with motor fluctuations and/or dopa-induced dyskinesia had the stn bilateral implantation surgery. Several complications were reported as noted below. Reportable event: long-term results showed 2 cases of major cognitive worsening, one following a cva that occurred several mos after surgery and the second was without obvious explanation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015213
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« Reply #26 on: January 13, 2014, 10:22:07 AM »

Model Number 3389
Device Problems Electro-magnetic interference (EMI); Implant, reprogramming of
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, the pt lost therapeutic effect and experienced facial numbness after leaning over some amplification speakers (containing magnets). No changes in programming were found. The pt was seen by a health care professional (hcp) for reprogramming two weeks later. The hcp suspected the pt may have experienced a small stroke which might have caused the symptoms. The hcp will perform additional test. Additional info has been requested, a follow-up report will be submitted when/if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1036465
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« Reply #27 on: January 13, 2014, 10:47:08 AM »

Model Number 3387
Device Problems Performance; Device remains implanted
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that following stage 1, bilateral lead placement in 2007, "they had noted a change in the patient". The physician indicated the patient had suffered a stroke (the exact date of onset was not reported); the event had been attributed to the lead device. The patient had been seen for one post-operative visit with the surgeon (exact date was not given). The patient had hemiplegia; it was unknown which side had been affected. She had received short-term rehabilitation (dates and type of facility were not provided), and had subsequently been discharged to home. The patient's condition was non-ambulatory; she had been able to walk prior to the surgery. The patient reported in 2008, that the system had been reprogrammed in 2008. No symptoms had been provided but the patient stated that after reprogramming "it helped for a short while". There had been painful right leg spasms, that had occurred whenever she sat down. She had tried increasing her parkinson's medications and achieved symptom suppression for a few hours before spasms would return. At follow-up for programming the following month, the hcp stated that the patient had been responding well to treatment but at times does have symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1013780
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« Reply #28 on: January 18, 2014, 12:28:01 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/29/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported the pt experienced a stroke in 2009. Several days later, the pt was to have a ct scan and experienced a loss of therapeutic effect with "staring into space with hardly a response". The pt was admitted to the hosp. It was unk if the device was on or off. It was requested the manufacturer's rep check the pt's system while in the hosp. No further outcome was reported. Additional info has been requested, a f/u report will be submitted if additional info becomes available. Please see mfr. Report #3004209178200901502.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1333325
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« Reply #29 on: January 20, 2014, 01:35:29 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 06/20/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Literature: okun ms, fernandez hh, wu ss, et al. Cognition and mood in parkinson's disease in subthalamic nucleus versus globus pallidus interna deep brain stimulation: the compare trial. Ann neurol, 2009; 65(5): 586-595. Summary: the study was a single-center, prospective, randomized, patient-and rater-blind, parallel-group trial that aimed to characterize and compare the effects of unilateral stn and unilateral gpi dbs on mood and cognitive function in patients with advanced pd. All patients were recruited, and some patients did not pass initial screening. A total patients were randomized to stn or gpi dbs. Forty-five patients completed the study. Reportable event: two cases of transient ischemic attack were reported. Symptoms occurred in both implant locations (stn and gpi). No patient treatment or outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425493
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