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Author Topic: Deep brain stimulator - Speech  (Read 85841 times)
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dennis100
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« Reply #30 on: December 07, 2013, 06:11:19 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 #31 on: December 08, 2013, 04:47:32 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
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dennis100
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« Reply #32 on: December 09, 2013, 05:34:52 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, 03:02:36 AM by dennis100 » Logged
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« Reply #33 on: December 09, 2013, 05:37:36 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: February 03, 2014, 03:02:51 AM by dennis100 » Logged
dennis100
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« Reply #34 on: December 09, 2013, 05:39:15 AM »

Model Number 37603
Event Date 05/12/2013
Event Type  Death   Patient Outcome  Death
Event Description
It was initially reported that around (b)(6) 2013, the patient started becoming ¿very uncommunicative and was very flushed. ¿ the following day the patient was taken to the hospital by ambulance. The patient was running a temperature of 103 degrees and was dehydrated. ¿all kinds¿ of tests were run, they did a flu swab and ¿no results indicated that there were problems of any kind. ¿ two days later around 2:30 the patient was sent home with antibiotics and by 7:30 ¿everything started up again. ¿ the patient was taken back to the hospital by ambulance, a general workup was done and ¿nothing showed up. ¿ a cat scan was performed and ¿that seemed fine. ¿ a lumbar puncture was performed the morning of this report which was ¿clear but they were running cultures. ¿ it was reported very late the night of (b)(6) 2013, the patient began having tremors on his right side and he would have problems communicating. ¿it was just words that you would not normally put together in a sentence to make sense and they were so jumbled his spouse could not tell distinctly what he said. ¿ it was reported the patient¿s device was programmed and turned on (b)(6) 2013 and it seemed to help with his tremor; the patient was able to pick up a pen and write, drink a glass of water without spilling it first, and he was feeding himself. It was noted the patient had not had any falls or trauma. It was also noted the patient¿s spouse thought it was possible the ¿emotional upheaval¿ of being in the emergency room twice could have attributed to his return of tremors. The patient¿s ¿problem¿ had not been determined. The patient¿s implanting physician recommended turning the patient¿s device off. It was further reported that the cause of the issue was autonomic dysregulation. It was not attributed to the device. No abnormal impedances were noted. An xray showed no device changes. It was then stated that the patient died due to a cardiac event on an unknown date in (b)(6) 2013. Additional attempts for follow up on date of death, device relationship and clinical course of death were unsuccessful. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative
Concomitant products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type extension; product id 3389s-40, lot# va07rd0, implanted: (b)(6) 2013, product type lead; product id 37642, serial# (b)(4), product type programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3207076
« Last Edit: February 03, 2014, 03:03:04 AM by dennis100 » Logged
dennis100
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« Reply #35 on: December 09, 2013, 05:43:23 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Death   Patient Outcome  Death,Required Intervention,Disability
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. It is also possible several events occurred in one patient. The patient information provided in section a is an average for all the patients. 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: 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: neu_unknown_lead, 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: 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: 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: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_lead, 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: 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: 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: 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: 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: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

 
Event Description
Franzini, a. , cordella, r. , messina, g. , marras, c. E. , romito, l. M. , carella, f. , albanese, a. , rizzi, m. , nardocci, n. , zorzi, g. , zekay, e. , broggi, g. Deep brain stimulation for movement disorders. Considerations on 276 consecutive patients. J neural transm. 2 011;118(10):1497-1510. Doi: 10. 1007/s00702-011-0656-z. Summary: the links between stn dbs and advanced parkinson disease, and between gpi dbs and dystonia are nearly universally accepted by the neurologists and neurosurgeons. Nevertheless, in some conditions,targets such as the ventral thalamus and the zona incerta may be considered to optimize the results and avoid the side effects. Positive and negative aspects of current dbs treatments justify the research of new targets, new stimulation programs and new hardware. Since 1993, at the istituto nazionale neurologico ¿¿carlo besta¿¿ in milan, 580 deep brain electrodes were implanted in 332 patients. 276 patients were affected by movement disorders. The dbs targets included stn, gpi, voa, vop, vim, cm¿pf, czi, ic. The long-term follow-up is reported and related to the chosen target. Dbs gave a new therapeutic option to patients affected by severe movement disorders, and in some cases resolved life-threatening pathological conditions that would otherwise result in the death of the patient, such as in status dystonicus, and post-stroke hemiballism us. Nevertheless, the potential occurrence of severe complications still limit a wider use of dbs. At today, the use of dbs in severe movement disorders is strongly positive even if further investigations and studies are needed to unveil potential new applications, and to refine the selection criteria for the actual indications and targets. The experience of different targets may be useful to guide and tailor the target choice to the individual clinical condition. Reported events: 1. 2 patients had a massive brain hemorrhage with a fatal outcome. 2. 6 patients had permanent neurological deficits due to deep hemorrhage 3. 8 patients had transient neurological deficits due to deep hemorrhage. 4. 7 patients had post-operative seizures. 5. 26 patients had hardware removed due to infection. 6. 6 patients had hardware removed due to infection and had a cerebral abscess at the origin of the stereotactic trajectory. 7. 30 patients had a hardware failure. 8. 20 patients had a late electrode migration. 9. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had a brain hematoma with hemiplegia. 10. 1 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had presented an unexplained fracture of the extracranic portion of the lead. It was noted that the patient underwent a successful lead replacement. 11. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had monolateral removal of their systems due to infection. 12. 17 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had hypophonia. 13. 11 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had dysarthria. 14. 1 pediatric patient suffering from a sever from of secondary dystonia had bilateral implantation ofdeep brain stimulation (dbs) system in the globus pallidus interna (gpi) and was successfully treated for 2 years before the stimulation device on the right side became infected because of skin erosion of the head along the path of the connector. It was noted that a right pallidotomy was performed by the dbs electrode before its subsequent definitive removal. 15. 4 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had migration of the electrode. It was noted that the complication was successfully managed. 16. 2 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had breakage of the electrode. It was noted that the complication was successfully managed. 17. 5 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an infection. It was noted that the complication was successfully managed. 18. 1 patient suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an intracranial hemorrhage. 19. 4 patient suffering from parkinson¿s disease with levodopa induced dyskinesia developed severe akinesia resistant to levodopa therapy after 4 years of chronic stimulation. 20. 3 patients had bilateral thalamic implants and had speech impairment. 21. 3 patients with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and were completely invalid. It was further reported that these patients did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. 22. 1 patient with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and was completely invalid. It was further reported that this patient did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. Additionally it was noted that surgery was followed by a relapse of the demyelinating disease. 23. 19 patients affected by advanced parkinson¿s disease had bilateral implants in the pre-lemniscal radiation (raprl) and had an incident of speech impairment of 36% and depression of 18%. 24. 4 patients affected by advanced parkinson¿s disease had asymmetrical implants in the pre-lemniscal radiation (raprl) and in the causal zona incerta (czi) on the contralateral side and had an incident of speech impairment of 36% and depression of 18%. Please refer to manufactures report # 3007566237-2013-02368 for additional information on a related event. 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=3233746
« Last Edit: February 03, 2014, 03:03:17 AM by dennis100 » Logged
dennis100
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« Reply #36 on: December 10, 2013, 05:31:53 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: February 03, 2014, 03:03:31 AM by dennis100 » Logged
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« Reply #37 on: December 10, 2013, 05:32:38 AM »

Model Number 37602
Event Type  Death   Patient Outcome  Death,Other
Event Description
It was reported the patient had suffered 2 seizures on monday following a device replacement. The patient could not talk or walk, and a stroke had been ruled out. The patient was at the hospital. Per the reporter, the patient looked like he was having an electrical shock in his upper body and it brought him to the ground. The reporter had seen the patient "shudder" during programming sessions in the past, and the reporter was concerned the device was related to the problem. The patient's health care professional did not think the devices were working, but this was not confirmed and the devices had not been turned off. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

 
Manufacturer Narrative
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 37642, serial # (b)(4), product type programmer, product id 3387s-40, lot # v009321, implanted: (b)(6) 2006; product type lead, product id 3387-40, lot # v00200,5 implanted: (b)(6) 2006; product type lead.

 
Manufacturer Narrative
(b)(4).

 
Event Description
Additional information received reported that the patient was fine when he went into the hospital to get the neurostimulators replaced, and he walked out of the hospital fine after the replacement. The patient was completely fine for a week after the replacement, and event went dancing. His speech had been hard to understand before the replacement, and after the replacement it was stronger and the patient stated "he had never felt better". On (b)(6), the patient was walking from the living room to the bathroom to get ready to go to the hospital to get his stitches out, when his wife heard a fall. She found that he had slid down the bathroom door and was sitting on the floor up against the door, experiencing an electrical shock. The patient was completely awake and alert, and experienced another electrical shock. The patient stated that he didn't know what happened, but it felt funny. The patient went to the hospital to get checked out, where he was seen by his neurosurgeon and a manufacturer representative. It was reported that one side of his body was drastically weaker than the other side, and on one side his leg turned in funny. It was reported that on one neurostimulator the settings looked normal, but on the other one the settings looked really high. The reporter wasn't sure which neurostimulator had the high settings, but she thought it was the left, and the settings were lowered. By (b)(6), the patient was in a semi-coma. While in the hospital, he was violent, was like in a "twilight sleep" and would lash out, wasn't talking, was barely eating and couldn't open his eyes. He was given a cat scan that ruled out a stroke, and blood and urine tests came back normal. It was noted that the patient had a urinary tract infection, but it wasn't bad. (b)(6) days later, the patient went to rehab for four to five days, because he was so aggressive and his eyes couldn't open, like they were stuck shut. The patient got worse in rehab, but it was noted that the hcp never shut off the neurostimulators because he believed it would make the patient's shakes really bad. The patient was taken on his levodopa, and he shook a little. (b)(6) weeks later, he was put into the psych ward and put on psych drugs because he was so aggressive in his sleep. The patient fell on floor a couple times and was then weaned off the psych drugs to make sure he wasn't having a reaction. He was then transferred to a hospice with the plan to transfer him to a home health or nursing home setting once he got better, however the patient died in the hospice. The death certificate listed the cause of death as failure to thrive and advanced parkinson's. Refer to mfr. Rep. # 3004209178-2012-03327.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2575695
« Last Edit: February 03, 2014, 03:03:43 AM by dennis100 » Logged
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« Reply #38 on: December 10, 2013, 05:34:06 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: February 03, 2014, 03:04:00 AM by dennis100 » Logged
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« Reply #39 on: December 10, 2013, 05:34:46 AM »

Model Number KINETRA
Event Type  Death   Patient Outcome  Death
Event Description
The neurosurgeon reported the patient had a device whose battery expired. The hcp "believes that the device fulfilled it's expected battery longevity and did not expire prematurely. " the patient was admitted to the emergency department unable to speak and dystonic. Their wild dystonic movement meant that pt tore their face to pieces and pt was wrpmg;u doagmpsed as status epilepticus. It was some time before the truth was discovered during which time pt developed severe infections after a battery replacement and dying after several months in intensive care through renal failure. " the coroner reported the cause of death as renal failure, septicemia, and dystonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=620213
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« Reply #40 on: December 10, 2013, 05:36:25 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Event Description
It was reported that the patient committed suicide as a result of complications and side effects from his implant surgery. The patient symptoms and side effects were: confusion, attention problems, choking, speech slurring, trouble forming words, weakness, increase in existing depression and sounds or sound sensation on the patient's left side of his head. He was active before the surgery, and after implant, he was never able to walk again. The patient's wife was unable to understand anything the patient would say. He often had a blank stare on his face for long periods of time. The day he committed suicide, he experienced sounds in his head, a whooshing sound on the left side of his head. It was noted that the patient had some depression before the surgery. Further information is being requested from the hcp.

 
Manufacturer Narrative
Slurred speech.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1468877
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« Reply #41 on: December 10, 2013, 05:37:14 AM »

Model Number 7426
Event Type  Death   Patient Outcome  Death,Disability
Manufacturer Narrative
(b)(4).

 
Manufacturer Narrative
Extension: model 748251, serial# (b)(4), implanted: (b)(6) 2003, explanted:; lead: model 3387-40, lot# j0306915v, implanted: (b)(6) 2003, explanted:. (b)(4). Date of death: the exact date of the month was unknown, therefore the first of the month was chosen.

 
Event Description
The patient passed away one month ago due to complications from the dbs surgery. The first surgery on one side was done (b)(6) 2003 and he had a slight bleed. He went to therapy for speech and memory and was fine. His second surgery was (b)(6) 2003; 45 minutes before the surgery of 6 to 7 hours he had a massive hemorrhage. He was put on a feeding tube, bedridden, could not speak, sit or walk. He had to be flown home from the hospital. For almost 9 years, he was "locked in his body" and his wife cared for him. It was noted that the had no follow up doctor. Additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2547617
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« Reply #42 on: December 10, 2013, 05:38:08 AM »

Model Number 7426
Event Type  Death   Patient Outcome  Death
Event Description
It was reported that the patient passed away in (b)(6) 2011. It was noted that since the patient received the implant, his speech was affected and for the last two years of his life he could not communicate at all. Subsequent information received reported that the patient's cause of death was parkinson's disease. It was unknown whether the device was related to the patient's passing. Further information received reported that the patient's passing was not device related and the device remained in the patient. If additional information is received, a supplemental report will be submitted.

 
Manufacturer Narrative
Product id neu_unknown_ext, serial# (b)(4), implanted: 2002 (b)(6), product type extension, product id neu_unknown_ext, serial# (b)(4), implanted: 2002 (b)(6), product type extension, product id 3387-40, lot# j0216861v, implanted: 2002 (b)(6), product type lead, product id 3387-40, lot# j0216861v, implanted: 2002 (b)(6), product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816205
« Last Edit: February 03, 2014, 03:04:39 AM by dennis100 » Logged
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« Reply #43 on: December 29, 2013, 04:14:39 AM »

Event Date 06/26/2000
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Disability
Event Description
The pt, with severe, medically refractory parkinson's disease, was in the process of undergoing surgery to implant a medtronic deep brain stimulating -dbs- lead into the left globus pallidus -gpi- in 2001. Pt had rec'd the first implant, on the right side, in 1999 without incident; due to progression of symptoms, the pt now elected to undergo contralateral dbs implantation. Microelectrode mapping -3 tracks- proceeded smoothly, with clear identification of motor gpi and optic tract. The pt was fully awake and cooperative. At the end of microelectrode mapping, the pt was noted to be slightly more hypophonic and slower in verbal responses, but had no motor deficit. The dbs lead was inserted superficially, 2omm above target, and the pt was reexamined. The pt had rapidly become obtunded, weakly following commands on the right side but not left. The procedure was immediately aborted, the scalp closed rapidly, and the headframe removed; the pt was intubated. During and before the onset of the deficit all vital signs had been stable, with systolic blood pressure = 120 mmhg; after the deficit became apparent, the pt briefly had increased blood pressure - systolic blood pressure = 170 mmhg, rapidly treated with labetalol. The pt rec'd an emergent head ct scan, which showed a 3 x 3 x 2. 5 cm - approx 12cc volume - hemorrhage in the left basal ganglia, without intraventricular or subarachnoid extension. Within a few hrs after the event, the pt followed commands more briskly on the left side, had some motion of the right leg, but could not move the right arm. Follow-up ct 8 hrs after the first showed no change in the hematoma. Pt is currently being treated with ventilatory support, mild hyperventilation, mild diuresis, and control of blood pressure. This event likely occurred at the end of microelectrode mapping. There were no warning signs of this event, no untoward events in surgery prior to the hemorrhage, no technical problems with surgery, and no special risk factors in pt's case. The pt's platelets and coagulation factors were normal the day prior to surgery. Intracerebral hemorrhage is a known risk of stereotactic brain surgery and is discussed fully in the study consent form.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=340641
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« Reply #44 on: December 30, 2013, 06:51:13 AM »

Model Number 7426
Device Problem Device remains implanted
Event Type  Malfunction   Patient Outcome  Other
Event Description
Patient experienced blurred vision, difficulty speaking and loss of symptom control while leaning over price scanner. Patient was reaching over scanner for items in cart and had to have help being removed from the scanner. Patients spouse was called and both devices were shut off. Emergency reprogramming was performed and device checked out. Patient is doing ok without residual effects. Patient cautioned not to get too close to price scanner and not to get the handheld screener close to the area. Physician will monitor patient. No report of device explantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=720319
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« Reply #45 on: December 30, 2013, 06:52:20 AM »

Model Number 3389
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Hcp reported intracerebral hemorrhage resulting in hemiparesis and aphasia. The pt underwent physical therapy. Minor cognitive difficulties resulted. No report of device explantation. A follow-up report will be sent if additional info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=543841
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« Reply #46 on: December 30, 2013, 06:54:17 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
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« Reply #47 on: January 01, 2014, 04:43:12 AM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Date 11/01/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Info rec'd by the mfr from a pt indicates the hcp performed a lead adjustment on the pt 1 week ago. Subsequent to the device revision the pt experienced symptoms of dizziness, difficulty walking and speech loss. The pt also provided they have experienced symptoms similar to the flu. The rep reviewed possible adverse effects with the pt and redirected the pt to follow up with their health care provider to report symptoms and be seen for medical eval. Add'l info has been requested from the hcp regarding the reported event. A follow up mdr will be sent if add'l info becomes available. See mfr report 2649622200602269.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=797254
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« Reply #48 on: January 01, 2014, 04:46:19 AM »

Model Number 3387
Device Problem Device remains implanted
Event Date 05/17/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Manufacturer is attempting to clarify written statements from the healthcare provider. A follow up report will be sent if these statements have been clarified.

 
Event Description
The patient's son reported the second lead was implanted in 2006. Within 24 hours, the patient exhibited signs of loss of function. Caller stated a ct scan showed fluid accumulation around the lead wire. The patient was partially paralyzed and unable to speak. Hcp reported patient symptoms included confusion, disorientation, difficulty finding words and inattentiveness after surgery. No weakness, fever, disability or hemiparesis was reported that day during non-focal motor exam. The event occurred eight hours post placement of the left stn deep brain stimulation electrode. The right electrode had been placed a month prior without incident. Ct scan showed air pockets and no edema after surgery. A ct scan performed two days later showed vasotonic edema in the cortex. A subsequent ct scan the next week revealed persistent vasotonic edema. The patient was readmitted to the hospital the day after the left electrode was placed and then sent to rehabilitation. During hospitalization, the patient's left leg became more stiff and dystonic. Hcp reported this was possibly due to lack of use and was partially present before stn deep brain stimulation placement. No surgical intervention performed. The patient's status returned to baseline over one month. The patient's motor exam returned to pre op by two months. Left leg dystonia was substantially improved with stimulation. Hcp reported by october or november 2006, the patient had no residual motor or cognitive side effect, and remarkable impact on parkinson's symptoms as the hcp adjusted the deep brain stimulation electrodes. Therapy is working well and the patient's thinking cleared.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=796262
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« Reply #49 on: January 01, 2014, 04:48:37 AM »

Model Number 7426
Device Problems Device remains implanted; Inappropriate shock
Event Date 09/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Info provided by the pt to the hcp shows that since november 2005 they experienced shocks on the left and right sides when the ins is adjusted. Pt reported symptoms of increased numbness on the left side of the face and mouth, and difficulty talking and eating. The hcp indicated the date of onset of the reported event was october 2005. The physician indicated a diagnosis of essential tremor and pt symptoms of tremor with action and posture. The physician reported changing product electrode settings and using different amplitudes for the pt. No report has been received by the mfr of device explant and the product has not been received for analysis. The pt has reportedly recovered without sequela. The hcp also stated the pt has not been seen for several months and currently symptoms are unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=786422
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« Reply #50 on: January 01, 2014, 04:50:33 AM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Manufacturer representative reports a patient having difficulty with ambulation and speech since implant in 2005. The patient was seen in clinic for troubleshooting. Lead impedance readings were all in normal range. The battery was at 2. 89 volts. The battery was nearing a low point but would not account for the complaints. Further follow up with the patient's hcp has not been possible. A follow up report will be sent when additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=772446
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« Reply #51 on: January 02, 2014, 02:47:48 AM »

Model Number 7426
Device Problems Device remains activated; Device remains implanted
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reports patient presented in 2006 with complaints of slurred speech neck and knee aches, and an inability to walk. The hcp saw the patient in clinic and performed troubleshooting for these events. The patient is medicated and has severe tremor in the left hand with moderate to severe tremor in the right hand. Speech is mildly slurred. During troubleshooting of the ipg was determined that the patient is experiencing neurodegenerative difficulty accounting for the unsteady gait a walker was recommended. The aching neck and knees are likely related to underlying arthritis and not related to the tremor. The slurred speech may be related to the tremor and improved with lower settings of the ipg, however, with lower settings the tremor worsened. The device remains implanted. The patient will see the hcp for follow up as needed. A follow up report will be sent if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=682007
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« Reply #52 on: January 03, 2014, 12:36:42 AM »

Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
The pt's sister reported the pt's speech was getting lower (softer) from the dbs therapy. The representative redirected the family member to report the pt symptoms to the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=873801
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« Reply #53 on: January 03, 2014, 12:40:25 AM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
The patient's husband reported, the patient is having difficulty in the right arm, she has experienced a difference in temperature; her right hand feels colder than the other hand. The patient also experienced tingling symptoms, located on the outside of the arm and extending to the thumb. The spouse reports the patient is having a very difficult time speaking. Additional information has been requested from the physician. A follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=831179
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« Reply #54 on: January 03, 2014, 07:02:19 PM »

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
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« Reply #55 on: January 03, 2014, 07:04:27 PM »

Model Number 7426
Device Problem Explanted
Event Date 01/18/2006
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
Final device analysis results revealed no anomaly found, normal device function.

 
Event Description
Hcp reported patient experienced unusual episodes of severe pain with dystonia on the right side of the face which would unpredictably appear. The device was explanted, replaced and returned to the manufacturer for analysis. The initial settings of the new device showed the unit was off completely. Hcp tried to use the prior settings from the old neurostimulator and the patient had severe dystonia and pain with speech arrest. Hcp adjusted the settings to 170 hz, pulse width 60 and overall voltage 0. 7 volts. The patient began to have significant symptoms with pulling in the right side of the face and hand. The patient felt the settings were very good. At the time of discharge, the patient had no additional problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=836834
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« Reply #56 on: January 03, 2014, 07:06:18 PM »

Model Number 3389
Device Problem Device remains implanted
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The patient's wife reported to the manufacturer in 2007 that the patient was at a hospital for treatment of symptoms of slurred speech and balance concerns. The spouse indicated they did not have a dbs therapy controller available to reprogram the unit. The patient's wife also indicated that they only live for four months each year and also have another residence in the state of wisconsin. The representative re-directed the patient to also attempt to obtain follow-up from the physician. Additional information has been requested by the manufacturer from the physician. No report of device explant has been received. A follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=819988
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« Reply #57 on: January 03, 2014, 07:08:53 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 #58 on: January 04, 2014, 03:28:04 AM »

Model Number 3387
Device Problem Device remains implanted
Event Date 09/01/2007
Event Type  Injury   Patient Outcome  Other
Event Description
The patient reported a loss therapeutic effect; they had experienced symptoms of speech problems and "a fast tippy-toe walk" and indicated their current condition was fair. The patient was redirected to report symptoms to the hcp and for medical evaluation. Additional information has been requested from the physician. Refer to mfr report #6000153-2007-04672.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971388
« Last Edit: January 04, 2014, 03:32:40 AM by dennis100 » Logged
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« Reply #59 on: January 05, 2014, 02:07:47 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Date 11/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient reported difficulty speaking and was wondering if the stimulator may need to be replaced. Additional information has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if additional information is received. Reference mfr report #6000153-2007-04270.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959284
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