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Author Topic: Deep brain stimulator - Swallowing  (Read 13857 times)
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dennis100
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« Reply #30 on: September 19, 2015, 03:10:54 AM »

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

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

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

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

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

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

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

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

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

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

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

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

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

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