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Author Topic: Deep brain stimulator - Walking/Gait  (Read 92676 times)
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dennis100
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« on: November 06, 2013, 12:43:21 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 07/08/2010
Event Type  Injury   Patient Outcome  Other
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.
 
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872749

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« Reply #1 on: November 06, 2013, 12:43:43 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.
 
Event Description

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229

« Last Edit: February 04, 2014, 03:38:39 AM by dennis100 » Logged
dennis100
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« Reply #2 on: November 06, 2013, 12:44:04 AM »

Model Number IPGNEURO
Device Problems Fracture; High impedance; Migration of device or device component; Device operates differently than expected; Device-device incompatibility; Unintended movement
Event Date 10/01/2009
Event Type  Injury   Patient Outcome  Death,Other,Hospitalization,Life Threatening,Required Intervention
Event Description

Literature: morishita t, foote kd, burdick ap, et al. Identification and management of deep brain stimulation intra- and postoperative urgencies and emergencies. Parkinsonism relat disord. 2010; 16(3):153-162. Summary: this article reviewed, identified, and suggested management strategies for both intra- and postoperative urgencies and emergencies in deep brain stimulation (dbs) pts, and separated the scenarios into surgery/procedure related; hardware related; stimulation-induced difficulties; and others. Ten case studies were included for illustrative purposes. Complications with dbs-specific manifestations were selected and a search was performed on each issue. The case examples were taken from a database between (b)(6) 2002 to (b)(6) 2009. An unspecified number of pts with parkinson's disease or dystonia experienced a returned of non-motor symptoms upon battery "failure," including depression and suicidal ideation. An unspecified number of pts with parkinson's disease and dystonia experienced a return of motor symptoms with battery "failure," including tremor, gait problems, and stiff legs. The source literature did not specify which device models were used. The pt info provided in section a is the average for all pts. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.
 
Manufacturer Narrative

(b)(4). This report is being submitted late due to a delay by a manufacturer employee. A process improvement plan and training are in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103904
« Last Edit: January 04, 2014, 01:12:16 PM by dennis100 » Logged
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« Reply #3 on: November 06, 2013, 12:44:22 AM »

Model Number NEU_INS_STIMULATOR
Device Problem Malposition of device
Event Date 01/01/2012
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
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. Continued concomitant medical products: neurostimulator model unknown serial# unknown implanted: unknown explanted: unknown; lead model unknown lot# unknown implanted: unknown explanted: unknown; lead model unknown lot# unknown implanted: unknown explanted: unknown. (b)(6).
 
Event Description

Literature: ullman, michael, vinata vedam-mai, andrew s. Resnick, anthony t. Yachnis, nikolaus r. Mcfarland, stacy merritt, pamela z eilman, kelly d. Foote, and michael s. Okun. "deep brain stimulation response in pathologically confirmed cases of multiple system atrophy. " parkinsonism and related disorders 18 (2012): 86-88. Print. Summary: deep brain stimulation is a treatment for select cases of medication refractory movement disorders including parkinson's disease. Deep brain stimulation has not been recommended for treatment in multiple system atrophy patients. However, the paucity of literature documenting the effects of deep brain stimulation in multiple system atrophy patients and the revelation of a levodopa responsive subtype of multiple system atrophy suggests further investigation is necessary. This study summarizes the positive and negative effects of deep brain stimulation treatment in two pathologically confirmed multiple system atrophy patients from the (b)(6) deep brain stimulation-brain tissue network. Clinical diagnosis for the two patient cases did not match the neuropathological diagnosis. We noted that in both pathologically confirmed multiple system atrophy patients, death occurred as a result of myocardial infarction. Importantly, there was reported transient benefit in levodopa responsive features that indicate deep brain stimulation may be an option for select multiple system atrophy patients. Reported events: the patient underwent a dbs implantation on the left side in the globus pallidus internus (gpi) in (b)(6) 2004. The measured lead tip location for the left lead was -24. 6, -0. 5, -3. 6 (x,y,z), and was felt to be lateral to the optimal position. Following surgery the patient developed expressive aphasia which resolved over several weeks with therapy. The patient later developed a worsening gait. A brain mri revealed a lacunar infarct in the pallidum/internal capsule region. The left gpi_dbs and stroke reportedly improved his right hemibody parkinsonian symptoms. Although the dbs lead was sub-optimally placed, the infarct may have offered a beneficial lesion effect. The patient underwent right gpi-dbs implantation and repositioning of his left dbs lead in (b)(6) 2005. The measured lead tip location for the right lead was 22. 19, 4. 79, -2. 5 (x,y,z), and the measured lead tip location for the revised left lead was -20. 69, 7. 2, 11. 5 (x,y,z). The left lead was dorsally placed anterior and shallow to the optimal location, but the patient reported satisfactory improvement in his symptoms. Complications after the second dbs procedure included worsening of his speech intelligibility and pronounced sialorrhea. It was unclear from the dbs-btn notes whether this was direct result of surgery, or due to natural disease progression. The patient expired at the (b)(6) from a myocardial infarction. He showed no early cardiac problems, but pathologic evaluation revealed arterial/arteriolar sclerosis. 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=2484883


« Last Edit: January 04, 2014, 01:14:25 PM by dennis100 » Logged
dennis100
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« Reply #4 on: November 06, 2013, 12:44:44 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Malfunction  
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 2. The patient had bilateral stimulation of the subthalamic nucleus (stn). The left lead had a short circuit with electrodes 0-3. Impedance measurements were less than 50 ohms. During the 5 years before the short circuit was identified, the patient experienced wearing off of therapeutic effect and freezing and propulsive gait during the off phase of medication, causing him to visit the hospital. Gait freezing may have resulted from a limited potential field due to the 2 anodes being involved in the short circuit. The patient also exhibited marked dysarthria and drooling. The patient's left implant delivered bipolar stimulation using contact 1 as a cathode and contact 3 as an anode. Therapy impedance was 794 ohms. Examination of system impedance revealed a short between contacts 3 and 0. Contact 0 was 6. 5mm under the midcommissural plane, suggesting a location in the ventral area of the stn. Altering the electrode setting to a unipolar stimulation using contacts 1 and 2 as cathodes led to the subjective alleviation of freezing and propulsion, but the sense of wearing off was not subjectively altered. These findings suggested that a short circuit between contacts 3 and 0 unexpectedly had limited the spread of the therapeutic potential field around contact 1. Short circuits were not suggested in radiographic examinations and were associated with no open circuits in a unipolar configuration. The cause of the short circuit was not identified.
 
Manufacturer Narrative

Product id: neu_unknown_lead, serial#: unknown, product type: lead; product id: neu_unknown_lead, serial#: unknown, product type: lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator: model 7424 or 7426 and lead model: 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860888
« Last Edit: January 04, 2014, 01:16:51 PM by dennis100 » Logged
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« Reply #5 on: November 06, 2013, 12:45:18 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Death   Patient Outcome  Death
Event Description

Yun, j. Y. , jeon, b. S. , kim, h. J. , kim, y. E. , lee, j. Y. , paek, s. H. Musculoskeletal problems need more attention in deep brain stimulation for parkinson's disease. Neurology asia. 2013;18(1):53-58. Summary: this study aimed to examine factors of poor outcome by analyzing the outcomes of bilateral subthalamic deep brain stimulation in parkinson¿s disease after 3 years. We assumed that patients who could not manage independent life in their best stimulation/medication-on condition after a defined period might not have been a good surgical candidate. A poor outcome is defined as a failure to maintain functional independence at three years during a stimulation-on/medication-on state. Results: a total of (b)(4) patients underwent bilateral subthalamic deep brain stimulation and all were followed up for 3 years. We excluded one patient who had intracranial hemorrhage. (b)(4) patients of the (b)(4) patients could not keep up independent life even during their best condition for the following reasons: freezing in (b)(4) patients, dementia in (b)(4), depression in (b)(4), musculoskeletal problems in (b)(4), and cancer in (b)(4) patient. Reported events: (b)(4) patient had depression and apathy, and committed suicide. (b)(4) patient had a gait disturbance due to freezing, depression and apathy, l-spine compression fracture, and a suboptimally placed electrode dorsomedially in the right side. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had dementia and apathy, and a suboptimally placed electrode anterior ventrolaterally in the left side. (b)(4) patient had dementia and apathy, depression, and a suboptimally placed electrode dorsomedially in the right side. (b)(4) patient had a gait disturbance due to freezing, dementia and apathy, l-spine compression fracture. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had a gait disturbance due to freezing, dementia and apathy, and a suboptimally placed electrode dorsomedially in the right and left side. (b)(4) patient had a gait disturbance due to freezing, a femur fracture due to a fall, and a suboptimally placed electrode posterior dorsomedially in the left side. (b)(4) patient had a gait disturbance due to freezing, and a l-spine compression fracture. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had a gait disturbance due to freezing, a l-spine compression fracture, and a suboptimally placed electrode dorsomedially in the right side. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had a gait disturbance due to freezing; severe autonomic dysfunction with multiple system atrophy; and a suboptimally placed electrode ventrolaterally in the left sided. (b)(4) patient had a gait disturbance due to freezing and a shoulder dislocation due to a fall. (b)(4) patient had dementia and apathy, and a suboptimally placed electrode dorsomedially in the right side. Further information has been requested; a supplemental report will be submitted if additional information is received. See attached literature article.
 
Manufacturer Narrative

Date of death is an estimate only. 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, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead. Lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# 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, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3163570
« Last Edit: February 04, 2014, 03:40:23 AM by dennis100 » Logged
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« Reply #6 on: November 06, 2013, 12:46:11 AM »

Device Problem No Known Device Problem
Event Date 04/13/2010
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: lai sc, jung sm, grattan-smith p, et al. Neuronal intranuclear inclusion disease: two cases of dopa-responsive juvenile parkinsonism with drug-induced dyskinesia. Mov disord. Jul 15 2010;25(9):1274-1279. Summary: this article described two children with neuronal intranuclear inclusion disease (niid) who presented with dopa-responsive juvenile parkinsonism, and who had initial good levodopa response that was complicated by disabling dopa-induced dyskinesia. Both patients died within 10 years of symptom onset. The article discussed differential diagnosis of clinical symptoms and neuropathological finds. Event: one female who underwent subthalamic nucleus deep brain stimulation (dbs) experienced a return of symptoms 6 months post surgery after initial improvement of tremor and bradykinesia, and depression and labile emotion one year after surgery. Subsequently, the patient experienced recurrent infections and died due to aspiration pneumonia approximately two years after surgery. The authors indicate that the patient's widespread pathology probably accounted for the lack of sustained response to dbs. The patient's motor symptoms prior to surgery had progressed rapidly and her cognitive function had declined. The patient had demonstrated severe gait ataxia, dysarthria, dysphagia, saccadic pursuit and nystagmus, blepharospasm and focal dystonia in distal limbs.
 
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. At this time no additional information was available, additional information has been requested. A copy of this article can be accessed at www. Interscience. Wiley. Com.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2143015

« Last Edit: January 04, 2014, 07:24:44 PM by dennis100 » Logged
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« Reply #7 on: November 06, 2013, 07:03:19 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/12/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: ferraye mu, debu b, fraix v, et al. Effects of pedunculopontine nucleus area stimulation on gait disorders in parkinson's disease. Brain. Jan;133(pt 1):205-214. Summary: the study looked at the effects of stimulating the pedunculopontine nucleus (ppn) area in six pts with severe freezing of gait due to parkinson's disease (pd). The pts had been unresponsive to levodopa and subthalamic nucleus (stn) stimulation. Event: one pt experienced a worsening in parkinsonism after surgically disconnecting the neurostimulator connected to the stn so a pre-operative mri could be performed. The pt suffered greatly from the arrest of the stn stimulation at the time of surgery and could no longer sustain it afterwards. At one-year f/u, stn stimulation arrest caused him severe akinesia, breathing difficulties and gait was impossible for several days afterwards, resulting in missing data. The symptoms were so severe, disconnection was not done for the remaining pts. The pt fully recovered.
 
Manufacturer Narrative

(b) (4) - used for akinesia and gait disturbance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658302
« Last Edit: January 04, 2014, 07:26:04 PM by dennis100 » Logged
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« Reply #8 on: November 06, 2013, 11:05:22 AM »

Device Problem Malposition of device
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: richardson rm, ostrom jl, starr pa. Surgical repositioning of misplaced subthalamic electrodes in parkinson's disease: location of effective and ineffective leads. Stereotact funct neurosurg. 2009;87(5):297-303. Summary: this article reports a retrospective analysis of 8 pts with idiopathic parkinson's disease who underwent surgical lead revision of deep brain stimulation (dbs) leads placed in the subthalamic nucleus (stn) to gain insight into the boundaries for dbs lead position targeting for effective and ineffective stimulation. Reportable event: the pt experienced improved tremor, rigidity, bradykinesia, and dyskinesia but persistent freezing of gait on one side and no improvement of symptoms on the other side following initial lead placement. The leads were determined to not be optimally placed. Following bilateral lead revision the pt experienced improved freezing of gait on the side where it had been persistent and no adverse effects on either side. See literature with mfr report #3007566237-2009-08911.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562484
« Last Edit: January 04, 2014, 07:26:38 PM by dennis100 » Logged
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« Reply #9 on: November 06, 2013, 11:05:49 AM »

Device Problem Malposition of device
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: richardson rm, ostrom jl, starr pa. Surgical repositioning of misplaced subthalamic electrodes in parkinson's disease: location of effective and ineffective leads. Stereotact funct neurosurg. 2009; 87(5): 297-303. Summary: this article reports a retrospective analysis of 8 pts with idiopathic parkinson's disease who underwent surgical lead revision of deep brain stimulation (dbs) leads placed in the subthalamic nucleus (stn) to gain insight into the boundaries for dbs lead position targeting for effective and ineffective stimulation. Reportable event: the pt experienced improved tremor, but persistent bradykinesia and freezing of gait. The lead was determined to not be optimally placed. Following unilateral lead revision, the pt had improved tremor, rigidity, and freezing of gait and no adverse effects. See literature article with mfr report #3007566237200908911.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562474

« Last Edit: January 04, 2014, 07:27:07 PM by dennis100 » Logged
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« Reply #10 on: November 06, 2013, 11:06:09 AM »

Device Problem Malposition of device
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: richardson rm, ostrom jl, starr pa. Surgical repositioning of misplaced subthalamic electrodes in parkinson's disease: location of effective and ineffective leads. Stereotact funct neurosurg. 2009;87(5):297-303. Summary: this article reports a retrospective analysis of 8 pts with idiopathic parkinson's disease who underwent surgical lead revision of deep brain stimulation (dbs) leads placed in the subthalamic nucleus (stn) to gain insight into the boundaries for dbs lead position targeting for effective and ineffective stimulation. Reportable event: the pt experienced improved tremor and rigidity, but persistent gait imbalance and adverse effects of hand dystonia and diplopia. The lead was determined to not be optimally placed. Following unilateral lead revision, the pt had improved gait imbalance and no adverse effects.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562476
« Last Edit: January 04, 2014, 07:27:41 PM by dennis100 » Logged
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« Reply #11 on: November 09, 2013, 02:52:46 AM »

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

Literature: farris sm, giroux ml. Gait changes after deep brain stimulation for parkinson's disease in a pt with cervical myelopathy. Neurorehabilitation. 2008;23(3):263-265. We present a male pt with significant gait problems due to parkinson's disease who underwent stn dbs. Gait worsened after surgery despite significant improvements in parkinsonian signs, due to underlying spasticity previously overshadowed by his parkinsonian motor symptoms. This case illustrates an emergence of dysfunction in gait in a pt with otherwise improved function and reinforces the need for an interdisciplinary approach to the care of these pts. Reportable event: one month after implant the pt had moderate to severe bradykinesia, rest tremor and rigidity, postural instability and gait worsening with falls. Eight months later after 6 months of extensive physical therapy his gait and balance significantly improved; he was able to walk without a ambulatory aid.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161219
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« Reply #12 on: November 10, 2013, 02:38:46 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2009
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative

 
Event Description

Literature: van nuenen bk, esselink ra, munneke m, speelman jd, va laar t, bloem br. Postoperative gait deterioration after bilateral subthalamic nucleus stimulation in parkinson's disease. Mov disord. 2008; 23(16): 2404-2406. Summary: the aim of this study was to evaluate the effects of subthalamic nucleus (stn) stimulation on gait relative to global outcome in a group of consecutively operated pts who had received stn stimulation between 2001 and 2004 in two major neurosurgical centers. All pts had the clinical diagnosis of parkinson's disease. A questionaire was sent to a total consecutive pts. A delayed worsening of gait after bilateral stn stimulation was experienced by a considerable proportion of pts (42% of subjects, for gait in the off phase), and this was apparently relatively selective because their global outcome scores continued to be improved. These findings highlight the presence of a hitherto poorly recognized long-term complication of bilateral stn stimulation. Event: one pt died. The cause was unk at the time of this report and f/u has been initiated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1422461

« Last Edit: February 04, 2014, 03:40:42 AM by dennis100 » Logged
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« Reply #13 on: December 06, 2013, 12:29:34 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that a week prior to the date of this report, the patient had a hard time moving his legs and arms. The patient was currently bedridden and unable to move. The patient would like to have the device reprogrammed. It was noted that the patient was currently hospitalized. It was later reported that the patient outcome was unknown. It was suggested that the patient to have programming done in the hospital but the result was unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447058
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« Reply #14 on: December 06, 2013, 12:30:17 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that after implantation of the stimulators, the patient¿s speech slowly began to worsen to the point where he was severely hypophonic and bradyphrenic at times when he attempted to speak. It was noted that over the prior few years, the patient had increasing stiffness and worsening posture and also had significant bradykinesia which increased when he walked. The patient underwent a revision of deep brain stimulation (dbs) leads a few years ago and at that time, it was noted that the leads dropped down the right side of his neck with the wires of both leads coming in contact with each other before they diverged into their respective generators in the bilateral chest.

 
Manufacturer Narrative
Product id 3389-40 lot# v005943, implanted: 2006 (b)(6); product type lead product id 3389-40, v005943, implanted: 2006 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 7436, serial# (b)(4), implanted: 2006 (b)(6); product type programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3459430
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« Reply #15 on: December 06, 2013, 12:31:04 PM »

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

 
Manufacturer Narrative
Concomitant medical products : product id: 3387-40, lot# v004533, implanted: (b)(6) 2006, product type: lead. Product id: 3387-40, lot# v004533, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3473120
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« Reply #16 on: December 07, 2013, 07:17:59 AM »


Model Number 3389S-40
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there was post-operative inflammation. It was noted that the patient was transient symptomatic post-operative with non-infectious hypo-density around the electrode. It was noted that approximately six days after implant the patient presented to the emergency room with confusion, nausea and vomiting. It was noted that the patient had severe gait and imbalance issues. It was noted that the patient had declined cognitive function along with confusion. It was noted that stealth with contrast head ct was performed to confirm diagnosis. It was noted that keppra and steroids were used to treat. It was noted that the issue resolved in 3 to 7 days. It was noted that another ct was performed on (b)(6) 2013 and the edema around the lead was resolved. It was noted that blood work was also performed. It was noted that there was no action required as a result of the event. It was noted that the patient was alive with no injury at the time of this report. It was noted that the battery had not been implanted yet. Additional information received reported that the lead was on the left side and there was swelling. It was noted that the patient had a complete right side system. Additional information received reported that the health care professionals (hcps) in the case were not saying the lead caused the issue. It was noted that the cause of the issue was unknown.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3474770
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« Reply #17 on: December 09, 2013, 06:09:47 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 04, 2014, 03:40:59 AM by dennis100 » Logged
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« Reply #18 on: December 09, 2013, 06:11:36 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 04, 2014, 03:41:12 AM by dennis100 » Logged
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« Reply #19 on: December 10, 2013, 05:25:31 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 04, 2014, 03:41:24 AM by dennis100 » Logged
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« Reply #20 on: December 10, 2013, 05:27:03 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
« Last Edit: February 04, 2014, 03:41:35 AM by dennis100 » Logged
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« Reply #21 on: December 10, 2013, 05:27:47 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
« Last Edit: February 04, 2014, 03:41:48 AM by dennis100 » Logged
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« Reply #22 on: December 10, 2013, 05:29:06 AM »

Model Number 7426
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 01/01/2007
Event Type  Death   Patient Outcome  Death,Required Intervention
Event Description
The pt experienced a warm feeling and burning sensation where his deep brain stimulator batteries were located. Movement and palpation caused stimulation changes. When he was resting, the pt was 'okay'; when walking it started to burn. The pt was seen by his general doctor and was put on 'nerve pills' which would work for a little while. Device registration system indicates the pt expired. Multiple requests for info have been made without success. A follow-up report will be submitted if additional info becomes available. Please refer to mfg. Report# 3004209178200803711.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069226
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« Reply #23 on: December 29, 2013, 04:20:32 AM »

Model Number 7426
Event Date 10/21/2001
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Pt underwent unilateral right sided implant of deep brain stimulator for parkinson's disease. Initial programming attempted after surgery but not completed due to pt fatigue. Pt was able to ambulate short distances without problems. According to a family member, while at home pt arose from a chair without assistance, fell and fractured their hip. Rptr believes there is no relationship of this incident to surgery or programming.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=360798
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« Reply #24 on: January 01, 2014, 04:31:22 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 #25 on: January 01, 2014, 04:32:51 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Date 08/16/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Information received via a clinical study report indicates the patient was implanted with bilateral deep brain stimulation leads and pulse generator in 2006. The patient recovered and all wounds (chest and scalp) healed well. The patient returned for a follow up visit one month later and had a tiny amount of drainage to the right edge of the scalp wound. The surgeon examined the wound and a cleansing regimine was recommended along with an oral antibiotic (augmentin) twice a day for 10 days. This initially helped, but a month later, the patient reported the small area of concern was larger and swollen. The patient was examined and the scalp wound was found to be infected. The patient was admitted to the hospital one month later. The patient will undergo exploratory surgery and will undergo either debridement of the frontal scalp wound or removal of the entire device necessary. Concomitant medications taken at the time of the adverse event include: sinemet, entacapone, amanatadine, zoloft, hdroclorothiazide, and asa. 10/2/2006 additional information received via clinical study report indicates that patient is now presenting with increased rigidity due to undermedication since explant of the dbs system. Since being discharged from the hospital the patient has removed some medications (including long action sinemet and comtan) and has increased short acting sinemet (to about every three hours). The medicine regimen is at odds with the discharge summary from the hospital. The patient's rigidity has increased over the last few days unitl finally the patient became so rigid he could not walk. The hcp reports the patient has no evidence of active infection, no fever, and surgical site is clean. The main issue will be to adjust the oral medication to match the patient's narrow therapeutic window. The patient was examined and treated with full medication as recommended in hospital discharge instructions. The patient is to continue antibiotics and will have replacement of dbs in the near future. The patient recovered well and was discharged home.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=772098
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« Reply #26 on: January 01, 2014, 04:34:35 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 #27 on: January 02, 2014, 03:01:28 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 #28 on: January 03, 2014, 12:49:03 AM »

Model Number LEAD
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
The patient reported that following dbs system placement; symptoms of tremor were adequately controlled, but the patient's ability to walk suddenly deteriorated. The representative re-directed the patient to report symptoms to her physician and to follow-up with the hcp regarding the patient therapy controller. Additional information has been requested. 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=832543
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« Reply #29 on: January 03, 2014, 07:19:13 PM »

Model Number 7482
Device Problems Device remains implanted; Wire(s), breakage of
Event Type  Malfunction   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

 
Event Description
Patient reported to the mfr on (b)(6) 2006 they were diagnosed with open wire (extension), as shown by x-ray exam. The patient provided additional information to the mfr on (b)(4) 2007 regarding symptoms that included rigidity, difficulty walking, and tightness felt over the battery for the past two months. The patient also indicated they were scheduled for follow up with the hcp during (b)(6) 2007 for an internal system check because the physician is concerned that an open or short circuit is possible. The date x-ray films were obtained and prior date of consult with the physician was not reported. No report of device explantation has been received. The product was implanted in (b)(6) 2006. It is unknown if both extension products were affected. Additional information has been requested from the hcp. See mfr report number 2649622-2007-00177.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2999653
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