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Author Topic: Deep brain stimulator - Walking/Gait  (Read 88291 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

« Last Edit: January 04, 2014, 01:09:06 PM by dennis100 » Logged
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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
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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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« Reply #30 on: January 03, 2014, 07:20:17 PM »

Model Number 7428
Device Problems Intermittent continuity; Explanted
Event Date 07/07/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The neurostimulator was returned after 44 months because generator underwent a power on reset, which caused the patient to be completely immobile. The device was replaced and returned to the manufacturer for analysis.

 
Manufacturer Narrative
Preliminary analysis results were not available on the date of this report. A follow up report will be sent when final analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=814307
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« Reply #31 on: January 03, 2014, 07:21:39 PM »

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 #32 on: January 04, 2014, 03:28:47 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, 03:31:59 AM by dennis100 » Logged
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« Reply #33 on: January 04, 2014, 09:12:50 AM »

Wish I knew if the inability to walk on these people, was a temporary thing  or not.  Boy, what a frightening side effect.
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"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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« Reply #34 on: January 04, 2014, 01:07:13 PM »

Deep brain stimulation is nothing but a barbaric medical procedure that is putting a steady flow of money into the pockets of the surgeons & neurologists (at our expense). Just like vagus nerve stimulation, does more harm than good.

All those responsible for the approval of those devices should be sent to the slammer!
« Last Edit: January 28, 2014, 05:19:35 AM by dennis100 » Logged
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« Reply #35 on: January 05, 2014, 02:34:39 PM »

Model Number 3389
Device Problem Implant, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Journal reference: tommasi, et al. Freezing and hypokinesia of gait induced by stimulation of the subthalamic region. Journal of neurological sciences, 2007, 258-99-103. A patient being treated for advanced parkinson disease with bilateral deep stimulation (dbs) experienced a gait disturbance (freezing and hypokinesia) related to the stimulation of a misplaced left sided dbs electrode. Repositioning/replacement of the left side electrode resulted in complete relief of the gait disturbance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=961723
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« Reply #36 on: January 05, 2014, 02:36:29 PM »

Device Problems High impedance; Device remains implanted; Implant, reprogramming of
Event Date 11/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported high impedance. The pt is receiving some efficacy, but has some freezing and afternoon/evening gate issues. The pt's medications have been reduced by 25 percent. The mfr rep interrogated the device and reported impedances >4000 ohms at 1. 4 volts, on all or some of the unipolar pairs. The rep repeated the impedance test at 2 volts and impedances remained high on electrodes 0 and 1. The rep reported the pt experiences a funny feeling in her head and has some motor responses at higher amplitudes, so the rep is unable to conduct an impedance check at higher amplitudes. The pt has only had the device implanted for 1 month and currently receives therapy benefit using electrode 2. The pt has some dyskinesia with the neurostimulator off, but the dyskinesia goes away when the neurostimulator is on. The system appears intact for programming; evidenced by the pt's positive response to therapy. Refer to medwatch report #2182207-2007-04414.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=964217
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« Reply #37 on: January 05, 2014, 02:38:00 PM »

Model Number 3387
Device Problems Explanted; Replace; Implant, reprogramming of
Event Date 07/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt's husband reported the deep brain stimulator electrodes were placed in 2004. Two weeks after implant, the pt's condition worsened. The pt experienced ambulation difficulties and needed a walker or a wheelchair to get around. The hcp reported the pt experienced parkinsonian dyskinesia including freezing, unsteady gait and leaning forward while walking. The pt complained of legs collapsing beneath them. The pt was reprogrammed several times. The pt's voltage was increased from 1 volt to 3. 5 volts. The hcp reported the pt experienced severe dystonic leg pain. The pt's medications were adjusted. X-ray, ct and mri scans revealed no abnormalities. The pt was referred to another physician. The pt was reprogrammed again. The device voltage was reduced from 3. 5 to 2. 0 volts. In 2006, the left lead and extension were removed and the right lead was repositioned. The left lead and extension were replaced in 2007. The pt is doing well and walking again. Refer to medwatch # 6000153200702669.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=900147
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« Reply #38 on: January 05, 2014, 03:57:01 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
The patient's wife reported the device was working well for the patient and he was walking without a cane. Then, a couple of times when the md would read the patient's device the patient would get a shock/jolt and his eyes would roll back in his head. She stated that the hcp would turn the device off and it took a while for the patient's arms to come back to his side. She reported that now the patient's mouth moves constantly and he can barely walk. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=898206
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« Reply #39 on: January 06, 2014, 09:22:24 PM »

Model Number 3387 OR 3389
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal reference: kupsch, et al. "pallidal deep-brain stimulation in primary generalized or segmental dystonia. " new england journal of medicine; 2006; 355: p. 1978 - 1990. Forty patients with primary segmental or generalized dystonia received implanted deep brain stimulation and were randomly assigned to receive either neurostimulation or sham stimulation for 3 months. The comparative results were reported on. Reported event: one patient experienced a gait disorder during the extension phase of the study. The symptoms were generally improved or resolved with changes in stimulation parameters.

 
Manufacturer Narrative
No medwatch form was received from the user facility; therefore, info on the medwatch form 3500a was completed by medtronic with info from the article. "any missing or incomplete data on form 3500a are the result of info not being provided by the reporter. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949264
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« Reply #40 on: January 06, 2014, 09:23:58 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each pt, the devices used and the complications experienced was not provided. It is possible that each pt may have experienced more than one complication. [see scanned pages].

 
Event Description
Journal reference: guehl, et al. "side-effects of subthalamic stimulation in parkinson's disease: clinical evolution and predictive factors" european journal of neurology; 2006; 13; 9 p. 963-971. The article presents study results describing the evolution of side effects in a cohort of patients at 3 and 12 months. The patients, all with advanced parkinsons disease, were being treated with bilateral deep brain stimulation of the stn. A number of pt complications were reported. Reportable event(s): there were reports of freezing with occasional falls. One pt reported the symptoms at 3 months and 3 reported symptoms at 12 months. Treatment and outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949477
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« Reply #41 on: January 06, 2014, 09:25:01 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication. No medwatch form was received from the user facility; therefore, information on the medwatch form 3500a was completed by medtronic with information from the article. See scanned pages.

 
Event Description
Journal reference: deuschl et al. "a randomized trial of deep-brain stimulation for parkinson's disease" the new england journal of medicine; 2006; 355; 9; p. 896-908. The article describes the results of a randomized-pair trial of patients with advanced parkinson's disease and severe motor symptoms. The study compared neurostimulation (deep brain stimulation) with medication only. A number of neurostimulation patient complications were reported. Reportable event(s): seven patients experienced severe worsening of mobility (4 mild, 1 moderate, 2 severe) requiring outpatient treatment. Treatment and outcome information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949284
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« Reply #42 on: January 08, 2014, 05:29:37 PM »

Model Number 7428
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 05/12/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient's home care physical therapist reported the patient's motor coordination and gait have decreased dramatically since implant. Additional information was requested from the patient's physician. The physician reported increased gait disturbance. A ct scan of the head was negative. Physical and occupational evaluations were conducted, along with multiple programming adjustments. No patient improvement with the device off. The patient is depressed and rehabilitation is ongoing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=881389
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« Reply #43 on: January 08, 2014, 05:30:17 PM »

Model Number 3389
Device Problems Device remains implanted; Implant, reprogramming of; Suspect EMI
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient reported following system reprogramming in 2005, his left foot would turn in, which made his knee hurt and he turned the right-side stimulator off. In 2006, the right-side stimulator was reprogrammed and turned on. One week later, his left arm and shoulder were stiff, his balance was poor and it was difficult to walk; the toes on his left foot curled. He reported his left shoulder and arm were worse with the stimulator off; he couldn't extend the arm over his head, it pulled up his side. The pt indicated he worked near high voltage and installed dc motors and rfid equipment readers, which may have damaged the dbs device and caused false readings. The following month, he was reprogrammed because problems with his left arm/shoulder and balance made work difficult. After reprogramming one month later, the pt reported no improvement in his symptoms. Approx four months later, the company representative suspected electrode migration at follow-up. His physician said the symptoms were due to disease progression; an implanting surgeon indicated the pt would not benefit from lead repositioning. The pt indicated after re-programming in 2007, the toes on his left foot curled up, he had slurred speech and poor balance. The company representative directed the pt to continue to report symptoms to his hcp. Additional info has been requested from the physician.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=884743
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« Reply #44 on: January 08, 2014, 06:08:50 PM »

Model Number LEADMVD
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 08/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported the patient has experienced a recent loss of efficacy; the patient is unable to walk. Therapy and bipolar measurements obtained were within range; battery measurements were as expected. The rep redirected the hcp to review patient symptoms with the physician; imaging was recommended if lack of efficacy continues.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=918355
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« Reply #45 on: January 08, 2014, 06:09:26 PM »


Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication. No medwatch form was received from the user facility; therefore, information on the medwatch form 3500a was completed by medtronic with information from the article. See scanned pages.

 
Event Description
Journal reference: deuschl et al. "a randomized trial of deep-brain stimulation for parkinson's disease" the new england journal of medicine; 2006; 355; 9; p. 896-908. The article describes the results of a randomized-pair trial of patients with advanced parkinson's disease and severe motor symptoms. The study compared neurostimulation (deep brain stimulation) with medication only. A number of neurostimulation patient complications were reported. Reportable event(s): some patients experienced worsening of mobility requiring admission to hospital. Treatment and outcome information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949285
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« Reply #46 on: January 08, 2014, 06:10:05 PM »

Model Number 7426
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 10/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient's friend reported the patient has never had good therapy, except for a brief time post-implant. The patient has new symptoms since implant that plague the patient daily (except while reclining): weakness, stiff neck, can't walk, head "feels" swollen and over-all malaise. The patient has been reprogrammed several times at the doctor's office. Device interrogation did not reveal any problems, however, lead placement was never checked. Surgery is not scheduled. Additional information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=943156
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« Reply #47 on: January 09, 2014, 09:15:27 AM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported the pt experienced difficulty walking after going through the airport while traveling. The pt did not have the hand-held programmer with him. The pt did not know if the device was on or off. The mfr reviewed the basic functionality of using a magnet to turn the device on or off. The pt was instructed to contact their hcp. Additional info has ben requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to the fda if additional info is received. Refer to medwatch report # 3004209178-2008-00720.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1001684
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« Reply #48 on: January 09, 2014, 09:16:19 AM »

Model Number 3387
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported, since implant in 2004, they have not had good therapeutic effect. The pt was implanted with a dbs system to treat essential tremor in their right hand. In 2005, the pt reported tingling in the tongue and arm. Reprogramming occurred once or twice but it was unclear if there was any effect. In eleven months later, the pt was feeling tingling in the hands and toes and then in 2006, the pt reported they became unable to walk. The pt indicated she was taking medications but did not provide any further info. The pt reported following several programming sessions in 2006, she turned the stimulator off. With the stimulator off, the pt reported the tingling is "very bad" and "very painful" and that she is using a wheelchair and can't walk. The pt reported mri scans had been performed but nothing was found to be the cause of her symptoms. Additional info has been requested from the pt's hcp but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=996516
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« Reply #49 on: January 09, 2014, 09:17:32 AM »

Model Number 3387
Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: murata et al. "deep brain stimulation of the posterior subthalamic area (zi. Raprl) for intractable tremor. " no shinkei geka 2007; 35(4): 355-362. Eight cases with severe essential tremor and 18 of tremor-dominant parkinson disease were treated with unilateral dbs of the area including the zona incerta and the prelemniscal radiation (zi/raprl). Tremors have been well controlled for 24 months with almost stable stimulation parameters, and no obvious adverse effects of stimulation. Reportable event: in some patients in whom the electrode was placed in a lateral approach, or in whom needed high voltage because of severe tremor, spasticity of the lower limbs was sometime seen during walking. Exact number of patients affected is not listed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989160
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« Reply #50 on: January 09, 2014, 09:18:33 AM »

Model Number 3387
Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: ostrem, et al. "pallidal deep brain stimulation in patients with cranial-cervical dystonia (meige syndrome). " movement disorders: 2007;22(13): 1885-1891. This article reports on a study of the effect of bilateral pallidal deep brain stimulation (dbs) in a series of patients (6 males, 1 female) with pharmacoresistant idiopathic cranial-cervical dystonia (iccd). Data for 1 patient (female) were excluded from the analysis because the post-op mri showed the left dbs lead not positioned at the intended target; the lead was later repositioned. Therefore, n=6. Patients were implanted with bilateral leads, quadripolar dbs (model 3387, medtronic); dual channel pulse generator (medtronic kinetra); 40-cm lead extenders. The mean age of patients at surgery was 66. 2 years (range, 52-70), and the mean duration of disease onset was 8. 2 years (range, 2-20). Four of 6 patients reported new difficulty with coordination and slowness in motor functions that had been normal and free of dystonia preoperatively: worsening of handwriting, typing, balance, and walking. Described as mild and not evidence on objective clinical exam, the deficits disappeared when the stimulator was turned off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991650
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« Reply #51 on: January 09, 2014, 09:19:34 AM »

Model Number 3387
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Gait changes in response to subthalamic nucleus stimulation in people with parkinson disease. A case series report. J neurol phys ther. 2006; 30(4): 184-194. The article describes the results from a case series that involved patients being treated with deep drain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. The goal of the study was to evaluate the effects of unilateral and bilateral stimulation on gait following staged stimulator implants. Three pts experienced worsening gait following bilateral stimulation. A male pt (2) experienced an increase in falls and freezing in the medication on state post bilateral stimulation. Unilateral stimulation produced a gait velocity decrease. No treatment or outcome info was provided.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982849
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« Reply #52 on: January 09, 2014, 09:20:19 AM »

Model Number 3387
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: kelly ve, samii a, slimp jc, price r, goodkin r, shumway-cook a. Gait changes in response to subthalamic nucleus stimulation in people with parkinson disease: a case series report. J neurol phys ther. 2006; 30(4): 184-194. The article describes the results from a case series that involved 6 pts being treated with deep drain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. The goal of the study was to evaluate the effects of unilateral and bilateral stimulation on gait following staged stimulator implants. Three pts experienced worsening gait following bilateral stimulation. A female pt (3) experienced a post surgery (unilateral and bilateral) slightly worsening of mobility (walking difficult). Gait velocity decreased with bilateral stimulation. Treatment and outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982850
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« Reply #53 on: January 09, 2014, 09:21:09 AM »

Model Number 3387
Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: kelly ve, samii a, slimp jc, price r, goodkin r, shumway-cook a. Gait changes in response to subthalamic nucleus stimulation in people with parkinson disease: a case series report. J neurol phys ther. 2006; 30(4): 184-194. The article describes the results from a case series that involved 6 patients being treated with deep brain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. The goal of the study was to evaluate the effects of unilateral and bilateral stimulation on gait following staged stimulator implants. Three patients experienced worsening gait following bilateral stimulation. A male patient experienced worsening of his gait following unilateral stimulation and difficulty walking following bilateral stimulation. The patient deactivated one of the stimulators when walking.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982610
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« Reply #54 on: January 09, 2014, 09:21:58 AM »

Model Number 3389
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 08/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's wife reported that the reprogramming had left her husband (the patient) unable to walk or talk since implant. She further reported that the patient's lead placement was good and she believed that the poor therapy was entirely related to the programming. She included that the patient's new hcp stated that he did not understand the settings the programmer used and could see why the patient had inadequate therapy. Additional information has been requested, a follow-up report will be submitted if additional information becomes available. See manufacturer's report# 6000153200800239.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979879
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« Reply #55 on: January 09, 2014, 02:07:59 PM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description
Journal reference: zesiewicz ta, sullivan kl, hoffman m, et al. Delayed thalamic intracranial hemorrhage in essential tremor pt following deep brain stimulation. Eur neurol 2008;59(3-4):187-189. We report the case of a man with et and a history of controlled hypertension who developed a delayed thalamic intracerebral hemorrhage (ich) almost 9 weeks following dbs surgery. Reportable event: the day after his nine week eval, which was normal, the pt woke up from an afternoon nap with right-sided arm and leg weakness, slurred speech, and a right facial droop. Neurologically, the pt was lethargic, oriented to his name and disoriented to place and time. Cranial nerve examination was significant for a right facial paresis. Motor examination demonstrated right upper and lower extremity weakness. Sensory examination demonstrated right hemi-hypoesthesia, and the pt had an extensor plantar reflex on the right. Ct and mri of the brain without contrast showed a left-sided thalamic ich adjoining the distal portion of the deep brain stimulator electrode. His dsb unit was turned off. His blood pressures remained stable, and he improved clinically having normal mmse, mild dysarthria, mild right facial weakness, and right upper and lower extremity weakness in the ensuing 6 weeks. He was able to ambulate with the use of a walker.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053631
« Last Edit: January 09, 2014, 02:09:54 PM by dennis100 » Logged
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« Reply #56 on: January 09, 2014, 02:09:07 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: granziera c, pollo c, russman h, et al. Sub-acute delayed failure of subthalamic dbs in parkinson's disease: the role of micro-lesion effect. Parkinsonism relat disord 2008; 14(2):109-113. We reviewed a cohort of 56 pd pts that underwent bilateral stereotactic stn implantation and we studied a subset of five pts that, after early clinical improvement, developed a rapidly progressive neurological deterioration unresponsive to dbs. Pts presenting delayed failure (df) did not differ from the rest of the cohort by any of the pre-operative characteristics; therefore, the presence of this micro-lesioning effect might be considered as warning sign for pts that need a careful follow-up. Reportable event: some pts developed, at df time, a degree of bradykinesia, and gait disorders that negatively influenced their dependency in activities of daily living. Some presented gait ignition failure, some had difficulties for turning around and bypassing obstacles, some pts suffered from festination and freezing while walking.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053617
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« Reply #57 on: January 09, 2014, 05:29:11 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: blomstedt p, hariz mi, lees a, et al. Acute severe depression induced by intraoperative stimulation of the substantia nigra: a case report. Parkinsonism relat disord 2008; 14(3): 253-256. We present a man with parkinson's disease (pd) who underwent bilateral stimulation in the subthalamic nucleus (stn). During the intraoperative evaluation, stimulation through the lowest contact in the right stn area, induced an acute depressive state, during which the pt was crying and expressing that he did not want to live. The pt returned to his normal state of mood within seconds after the cessation of stimulation. Repeated blinded stimulations resulted in the same response immediate postoperative magnetic resonance imaging (mri) revealed that the lowest contact of the right electrode was located in the substantia nigra. Reportable event: the pt has now been followed for 5 years. During this period, no changes in mood have been noted, nor any other psychological or cognitive change. The main recent complaints have been gait and balance difficulties, freezing of gait and stuttering (freezing of speech) when on medication and on stimulation.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1057804
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« Reply #58 on: January 09, 2014, 05:29:42 PM »

Model Number 7426
Device Problems Battery failure; Replace
Event Date 08/01/2006
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that the pt experienced ambulation difficulties, return of tremor, and had difficulties completing activities of daily living. An x-ray was performed (2006), no fractures were detected in the deep brain stimulation system. There was also no response from the left neurostimulator (ins) when telemetry was attempted. The pt's left ins and extension were replaced. The pt regained therapeutic benefit. The pt recovered without sequela.

 
Manufacturer Narrative
The serial number is included in the range for the medtronic kinentra/soletra lifted bond wire recall (2007). Lifted bond wire could not be confirmed in this device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059470
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« Reply #59 on: January 09, 2014, 05:30:07 PM »

Model Number 7426
Device Problems Loss of power; Program, failure to
Event Date 04/02/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt woke up feeling fine. Forty five minutes later, the pt knew something was 'not quite right'. He started having more left-sided tremor and fell backwards, but was caught by a family member before he fell. It was also reported that the pt was unable to feel stimulation after a fall down the steps or some other trauma. The pt was unable to adjust stimulation. The pt was seen by his primary hcp the day of the incident. He had a neurology consultation approx 7 days after the original incident. There he had a pronounced increase in left arm tremor. It was harder for him to walk and he had been dragging his left leg more. Voice quality was originally alright, but later the pt noticed that he was stuttering more. He was having some drooling, greater on the right side. Facies were somewhat flat, although he could smile and laugh during the exam. He had micrographia. His last deep brain stimulator programming was four months prior to the exam. Physical exam also revealed left arm rigidity. He had +3 left arm rigidity and a 2-3 tremor, although at times it did quiet down. He had +1 increased tone and rigidity of his right hand. He was unable to do finger taps at all with his left hand and was able to do taps with his right, although he did demonstrate some bradykinesia. Hand pronation and supination again demonstrated bradykinesia bilaterally, left greater than right. He had strong hand grasp bilaterally. He did not drift with eyes closed and arms extended. He had a fine tremor, left greater than right when his arms were extended at rest. He had bilaterally increased tone and rigidity of the lower extremities. He was +2 on his right leg and +4 on his left. There was no tremor of his lower extremities at exam. Foot taps demonstrated decreased amplitude in his right more than left; both demonstrated bradykinesia. He arose independently from a chair using both arms to push up with multiple attempts. While up walking with his walker, he had some bradykinesia, but was able to pick up both of his feet and did not demonstrate any real shuffling at exam. He took a slow turn. No interrogation was possible with the device stimulating his right brain/left side of his body. Left brain neurostimulator settings and impedances were within normal limits. The hcp increased the stalevo 50 mg from 4 to 5 times a day. The pt and his wife were instructed how to increase his medications if needed to control his oral symptoms. The device had been or will be replaced.

 
Manufacturer Narrative
The report was submitted late by the mfr's rep, retraining has been conducted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1068140
« Last Edit: January 09, 2014, 05:34:52 PM by dennis100 » Logged
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« Reply #60 on: January 09, 2014, 05:36:06 PM »

Model Number 7428
Device Problem Replace
Event Date 10/31/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt underwent removal of the bilateral gpi dbs leads and implantation of stn placed leads. The pt had the dbs sys placed in 2005. The pt did not receive benefit. The pt became progressively more disabled despite implantation of dbs. The pt was evaluated prior to the revision. The pt's only new complaint was that he noted some difficulty urinating while standing although he felt he was able to fully empty his bladder while in a sitting position. He had no dysuria or other urinary tract complaints. The pt had been started on lasix 20 mg/day for peripheral edema in 2008. It had been somewhat effective in improving the edema in his hands and ankles. The pt had no shortness of breath, chest pain, or other cardiopulmonary complaints. The pt was admitted to the hosp in 2006. The pt's physical exam revealed blood pressure 112/64, heart rate 76, respirations 16, pt's weight which was decreased by two pounds since the month before. Exam was otherwise unchanged from previous exams. It was notable for an irregular cardiac rhythm, dyskinesias of the arms and legs, slow shuffling gait, and abnormal posture with the upper body held in a forward, flexed, position. There was trace to 1+ pedal edema noted. The leads were replaced. The new leads were connected to the previously implanted extensions and the generators were tested. The impedances were found to be normal. The procedure was well tolerated. The pt was discharged on two days later. Prognosis for improvement of pd motor symptoms was good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1066633
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« Reply #61 on: January 09, 2014, 05:37:27 PM »

It's criminal. F_ _ king criminal
« Last Edit: February 04, 2014, 03:44:23 AM by dennis100 » Logged
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« Reply #62 on: January 12, 2014, 05:22:54 PM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: piboolnurak et al. "levodopa response in long-term bilateral subthalamic stimulation for parkinson's disease" movement disorders/2007/22/7/990-997. This article describes a long-term follow-up of 33 pts with dbs therapy for parkinson's disease. Reportable event: there was a total of 2 adverse event reports of freezing of gait during the follow-up. No add'l info or outcomes were provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015662
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« Reply #63 on: January 12, 2014, 05:27:03 PM »

Model Number 3387
Device Problems Lead(s), breakage of; Unknown (for use when the device problem is not known)
Event Date 02/28/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported a return of tremor and freezing on the left side of the body and problems with speech. The pt was traveling when the symptoms began. F/u with the pt's hcp indicated the pt has had good outcomes from dbs therapy until recently when he lost efficacy over the left side of the body. In addition, both of the ipg devices were near battery depletion and needed replacement. The symptoms began while traveling. In the airport the pt began having increase of parkinson's symptoms on the left side. The pt began to have difficulty walking and later bothered by rigidity, tremor, and bradykinesia on the left side. The sys was interrogated and showed"breaks" on the right side. The pt was treated with sinemet to compensate for the lack of effect from the sys. On exam, the pt exhibited hypophonia, dysarthria, and, after an increase in the sinemet dose, some mental status changes (unspecified). Muscle strength was 5/5 for both upper and lower extremities, muscle tone was normal and without evidence of atrophy, cogwheeling: was moderate bilaterally, tremor: resting moderate on the left. The pt had moderate gait shuffling. An x-ray was performed and was suspicious for dbs lead breakage but was not conclusive. The hcp planned to surgically replace both ipgs. During the procedure, the right extension will be tested and replaced if necessary. If the break is localized to the dbs electrode, another surgery with stereotactic frame will be required. The pt's concommitant medications include: sinemet, metoprolol, vitamin b12 injection, carbidopa-levodopa, selegiline hcl, glucophage, lipitor, senna leaves, ocupress 1% eye drops.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022900
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« Reply #64 on: January 13, 2014, 02:44:05 AM »

Model Number 3387
Device Problems Lead(s), breakage of; Replace
Event Date 03/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that a system check ten days after pulse generator change-out revealed lower therapy impedance measurements from the new ipg; the impedance of 987 ohms, was compared to 1640 ohms for the prior ipg, and a fluid shunt was suspected. The patient was receiving adequate therapy control and the physician would monitor the system. Approximately one month later, the patient realized total system explant when x-ray exam (date not provided), revealed a fracture of the lead product subsequent to a patient fall. Telemetry data was not provided. The patient had experienced speech changes and changes in ambulation; the date of symptoms onset was unknown. After system replacement, the patient reportedly had a "full return to prior status" and has recovered without sequela. Refer to mfr report #6000153200802619.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047217
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« Reply #65 on: January 13, 2014, 08:42:56 AM »

Model Number 3389
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The spouse had reported on 11/07, there had never been therapeutic effect when stimulation therapy was turned on, the pt's symptoms had improved (he was better), with stimulation turned off. The hcp provided summary notes for pt follow-up between 2 months in 2007, timeframe. All impedance checks in 2007, has been normal (exact values were not provided), the unilateral dbs system had been reprogrammed several times without improvement. Symptoms of neurological deficit was described as "freezing. " the pt was seen in 2007, for initial reprogramming after dbs placement. Initial settings were 1-, case +, 2. 0 v, 90 unsec. When the voltage was turned up to 2. 5 v the pt had "slight skewed diploia. " subsequent settings were 2-, case +, 2. 0 v, 90 unsec, which caused a "dramatic reduction in dyskinesia. " a follow-up 3 days later, the pt had improved and his medications lasted 2. 5 to 3 hrs, versus 2 hrs. It was noted when medications wore off the pt had difficulty walking; he would freeze and would either hop from place to place, to break the freeze, or he would lean into furniture and drag his legs behind him. When the medications worked, he had dyskinesia. The pt omitted levodopa prior to exam; he had no dyskinesia, his speech was clear and he had not seemed distractible or inattentive. There was mild upper extremity and mild to moderate lower extremity rigidity; he had obvious freezing upon initiating and maintaining gait. The pt could not walk effectively for more than a few feet. During reprogramming, setting were 2-, case +, and the voltage was increased from 2. 0 to 3. 0 v, initially keeping the pulse width at 90 usec with no change seen in tone, bradykinesia, or freezing. When the pulse width was widened to 120 usec, the pt's speech became muffled; he had appeared less attentive while conversing and the pulse width was returned to 90 usec. The pt took his medications, which then showed mild right-sided and moderate to severe left-sided dyskinesia, his gait had been normal with good stride length and balance, with stimulation on. At follow-up on 09/21/07, the pt had suffered a fall that required sutures (no details were provided). Settings at 2-, case +, 3. 0 v, showed some on freezing, his gait became worse when off. Settings of 2-, case +, 3. 5 v, still showed on freezing with improvement. Additional settings of 1+,2-, 2. 0 v, 90 usec, and 185 hz showed no obvious on freezing, there was some residual freezing but his medications appeared to be effective for a longer period of time. The pt would discontinue comtan. Approx 2 weeks later, the pt was seen for "further dbs titration"; symptoms of moderate left-sided and mild right-side dyskinesia were noted. Upon initiating gait, there was slowness to move the right-foot and slight freezing in the right lower extremity (rle). When settings changed from 2. 0 to 2. 5 v, the pt showed significant freezing of the rle upon walking. The voltage was increased to 3. 0 v, and the freezing became worse; subsequently the voltage was decreased to zero and freezing appeared to improve. The anode and cathodes were reversed to (1-, 2+), at a setting of 2. 0 v, and 90 usec, which showed improved gait. The pt was discharged at 2. 0 v, and was referred to physical therapy. A follow-up about 2 weeks later, the pt continued to have difficult freezing, which occurred prominently between doses of levodopa, but had also occurred while on levodopa medication. The symptoms were deemed to be a "side effect of dbs off freezing," which had been less prominent pre-operatively, the on freezing was new. On exam he had moderately severe left-sided and mild right-side dyskinesia; freezing was noted upon gait initiation. His speech was normal. Dbs therapy was inactivated; voltage was set to 0 v and the device was turned off. The pt anticipated travel in the following month. Refer to mr report #3004209178200704569.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006019
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« Reply #66 on: January 13, 2014, 10:32:31 AM »

Model Number LEADMVD
Device Problems High impedance; Device remains implanted; Implant, reprogramming of
Event Date 12/14/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that prior to implant the pt's tremors were interfering with his ability to work as a music director and organist. He was requiring significant amounts of alcohol in order to control his tremors and the alcohol was a problem for him. In late 2007, it was noted that the pt had returned 3 days after his last visit for follow-up of essential tremor. His last adjustments to the dbs devices were not satisfactory. By the next day, when he tried to write, he was having writing difficultly, his walking was not good, and his speech was slurred. He had some tenseness in his fingers at times when was playing keyboards. During impedance checks, the impedance on electrode 3 was greater than 4000 ohms. Reprogramming was done and the pt was satisfied with the decrease in symptoms, although they were not completely gone. In early 2008, the pt was having difficulty controlling his hands on the keyboards such that he was unable to play. He had increased tremor and decreased dexterity. He was not drinking alcohol lately and did not want to go back to it for control of the tremor. He tried taking primidone without benefit and stopped it. Impedance readings on electrode 3 were greater than 4000 ohms. Reprogramming was done. The pt was able to play scales on the keyboard more fluidly. He still had significant postural tremor, but was overall improved. On the following month, the pt came in with the stimulator off. He was concerned because he had to take a cut in pay from work because of his difficulty with using the keyboard. He had a very mild voice tremor, a mild wing-beating tremor (left greater than right), and he could not drink water. Reprogramming was done; the pt was pleased; the pt's symptoms improved, but were not completely gone. On the next month, the pt was still having suboptimal control of his tremors such that he had to stop playing the organ. He had transient benefit from the previous reprogramming, but he stated that by the time he went home, he was not having benefit from the adjustments. He tried to increase and decrease the dbs power, but without noticing any benefit when he turned the device on and off. The impedance measurement on electrode 3 was greater than 4000 ohms. The pt was being scheduled for an mri to check lead placement. The pt outcome was reported as "non-serious injury/illness".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045101
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« Reply #67 on: January 13, 2014, 10:33:12 AM »

Model Number 3387
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 02/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient had a loss of therapeutic effect following the most recent programming session. The patient's symptoms were reported as ambulation changes, neurological deficit of akinesia, and speech changes. The patient's device was reprogrammed and the patient experienced improved motor function. The patient recovered without sequela. Please see mfr. Report #600015320082378.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1037633
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« Reply #68 on: January 13, 2014, 10:52:15 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1013780
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« Reply #69 on: January 14, 2014, 11:51:31 AM »

Model Number 7428
Device Problems Loss of power; Replace; Implant, reprogramming of; Low battery
Event Date 08/13/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The pt experienced acute hypokinesis and a sudden worsening of parkinson disease symptoms. He was hospitalized about a week later when he was no longer able to walk or perform activities of daily living. The deep brain stimulator was interrogated and found to be off. Stimulation parameters were changed and the pt improved. The pt required increased medication dosages. The generator battery was at end of svc. Device registration sys indicates the deep brain stimulator was replaced. The hcp/study investigator reported that the adverse event was also possibly related to parkinson medication therapy, parkinson disease progression, and a low serum potassium (not specified) and hematocrit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1180198
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« Reply #70 on: January 14, 2014, 11:52:36 AM »

Model Number 7426
Device Problems Replace; Wire(s), breakage of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal ref: farris s, vitek j, giroux ml. Deep brain stimulation hardware complications: the role of electrode impedance and current measurements. Mov disord. 2008;23(5):755-760. We present four pts with evolving dbs hardware complications that occurred during long-term follow-up, that shaped our clinical protocol for long-term care mgmt and hardware troubleshooting. Reportable event: pt 4 is a woman with pd for 40 yrs and bilateral stn dbs and soletra ipgs for 4 yrs, with sustained improvement in her symptoms for 2 yrs. Right stn settings were 3. 1 v, 60 microseconds, 185 hz, cathode electrode 1, and anode electrode 2. Her motor symptoms were stable until after she underwent bilateral ipg replacement. No impedance checks were performed before or after ipg replacement. Shortly after surgery, tremor, rigidity, gait freezing, dyskinesia, and falls began to worsen. She did not regain control of motor symptoms and medication changes were limited by cognition and dyskinesia. Sixteen months later, she had an abrupt increase in tremor associated with discomfort around the right ipg. Her skull x-ray showing a break in the extension wire with a single wire remaining intact without wire insulation. Extension wire replacement improved her tremor and dyskinesia over the next 9 months. See mfg report 2182207200803754. (see scanned pages).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069474
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« Reply #71 on: January 14, 2014, 11:53:08 AM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 08/23/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt had a return of symptoms that was not controlled by the stimulator system. The pt had a difficult time walking and fell on a saturday and sunday. The pt did not land on her device side. The pt felt tingling when the stimulator was turned on. The tingling occurred in both her fingers and her feet. The pt was at home at the time of the report; the pt status was undetermined. The pt was directed to contact the physician. Add'l info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1178927
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« Reply #72 on: January 14, 2014, 01:24:37 PM »

Model Number 7426
Device Problems Explanted; Program, failure to
Event Date 06/10/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient was implanted with 2 deep brain stimulation (dbs) devices in 2008. The stimulators had been programmed 2 times successfully since implant. At the third programming session, the left device failed to program; 2 programmers were used, the device could not be detected by the programmer. The device was explanted. In the process of communicating with the pt and asking in detail about the family situation and other treatments the following was obtained. The pt was unable to walk; it was unclear if the pt's inability to walk was before the explant of the device or after it. The pt was recuperating at home; watching television. The pt denied other treatment history and denied a history of wrestling. The pt denied contact with a special magnetic. The pt traveled from shandong and shanghai via long-distance sleeper cars. The pt lived in rural shandong qingzhou in a cottage that was not hear a power line substation or steel plant.

 
Manufacturer Narrative
The device has been returned to the mfr for analysis, which is not complete as of the date of this report. A follow-up report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1075491
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« Reply #73 on: January 14, 2014, 01:25:07 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The health care professional reported that postoperatively, the pt experienced seizures and had difficulty with gait and speech. The pt spent a month in rehabilitation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1080746
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« Reply #74 on: January 14, 2014, 01:25:49 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient was hit in the head with a rock and experienced a loss of therapeutic effect and a return of tremors. The patient was unable to walk one morning. The patient had not fallen. Her status was reported as fair. Approximately 3 weeks later the patient experienced muscle and joint soreness when stimulation was turned on. The patient contacted the hcp office and was told it was probably a viral infection. Additional information has been requested a follow-up report will be submitted if additional information becomes available. Please see mfr. Report # 3004209178-2008-05272.

 
Manufacturer Narrative
The patient has bilateral deep brain stimulation systems. It is unknown which device to attribute the adverse event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1138734
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« Reply #75 on: January 14, 2014, 01:45:19 PM »

Model Number 3387
Device Problem Device remains implanted
Event Date 11/27/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported the patient status one-day post dbs revision; interrogation of the left-sided system had revealed one impedance value remained less than 50 ohms. The interrogation numbers obtained were: electrode impedance 646, 654, 850, 789, <50, 1076, 1058; other values were deemed to be within normal limits. The left-battery impedance was 927 with current of 29, and battery voltage was 3. 74, the battery "was reading ok. " the patient electrode settings were 3+, 0-, amplitude was 1. 8, pulse width was 90, and pulse rate was 130. When the hcp "tried to go higher on his amplitude the right-side of his face went numb, and his ability to speak decreased. " the pulse width and pulse rate were turned down to the settings listed above, but they "could not go any higher on the amplitude without getting side effects. " the patient stated he was comfortable at the prior settings and his right arm tremor was gone. He had not taken any medications since the previous evening and the patient was discharged to home (nursing home), in 2007. At follow-up the following month, the patient reported he felt "the same" and was tired; he had continued to work with physical therapy and had felt stronger. The patient could "walk about 5 steps before his legs give out. " there had been no falls or syncope symptoms subsequent to hospital discharge. The patient had turned dbs therapy off; he attributed increased weakness and diarrhea, including the loss of bowel control to the devices. He had the onset of gastrointestinal upset and diarrhea within 2-3 hours when stimulation is turned on that resolved when therapy is turned off. The patient had "repeated this scenario with consistent results, unable to use dbs implant," the patient had left stimulation off to avoid the affects of diarrhea. On the same day, (visit notes continued): the patient continued with right-sided tremor, symptoms were greater in the right-hand than the leg; the patient reported "trouble turning in at night. " he was eating and drinking well and had used lortab for right-hip and back pain with good relief. Results of physical exam had shown the patient was well-groomed, well-nourished in no acute distress; his attention span and concentration were normal and in no acute distress; his attention span and concentration were normal and appropriate for his age and education level. The patient's speech had been clear, his smile was deemed symmetrical and intact. There was right-upper extremity resting tremor, they were unable to test gait. The patient would continue with current medications, he would take rozerem every night. At follow-up five days later, the dbs therapy had remained off due to uncomfortable bowel movements. The patient had indicated that he had not experienced uncontrollable bowel movements subsequent to turning off stimulation therapy. It was also "noted that before this battery change he was up and walking, but is now in a wheelchair, and he stated that his legs felt like rubber. " the hcp indicated that the patient had been programmed until right-facial pulling was detected and the patient reported tingling in his right-hand and right-foot; "it was very difficult to turn up any of the controls because he would get right facial pull and tingling in his right hand and foot. " system adjustments were reported as: electrode settings, 3+, 0-, amplitude 1. 6, pulse with 90, pulse rate 100. Impedance readings were 868, 881, 1022, 1049, <50, 1227, 1424, 1227, 1441, 1239. Battery impedance was 1132, current 25, battery voltage was 3. 75, the reading was "ok. " the sinemet cr 50/200 medication was increased to twelve tablets daily; all other medications remained unchanged. The next day, the patient was seen at the clinic for suture removal from the scalp post-replacement of the left-sided extension; the incision had been well-healed, the sutures had been removed without difficulty. The patient was seen for follow-up the following month, visit notes had been unavailable. The patient would be referred for further evaluation of the dbs system and would be referred to the neurosurgeon, if needed. The patient outcome had been reported as non-serious illness or injury related to gi symptoms of diarrhea. Refer to mfr reports #6000153200704467, #2182207200800451, #2182207200800452, #6000153200800453, #2182207200800454.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989147
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« Reply #76 on: January 14, 2014, 08:19:17 PM »

Model Number 7426
Device Problems Device remains implanted; Malfunction
Event Date 09/29/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a sudden loss of therapeutic effect on one side (unspecified) of the dual dbs system. The status of one dbs system was checked with the patient programmer and was fine. The other side was unable to be checked with the patient programmer. When attempting to verify programming there was no action only the battery light. The patient had not seen their physician for a couple of months but was scheduled to see them next month and had contacted the physicians office about the problem. The symptoms started all of a sudden in 2008. The patient had a return of symptoms, couldn't walk, feet would point out in opposite directions, was sweating, thirsty, and had increased pain. It was unknown if it was the right or left dbs system that was indicated in the event. The patient remained at home in fair condition. Additional information has been requested, but was not available on the date of this report. See mfr report #3004209178200807008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216402
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« Reply #77 on: January 14, 2014, 08:59:45 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 08/21/2008
Event Type  Injury 
Event Description
The patient was in an auto accident in which the left side of his body was impacted. Afterward, he experienced a shocking, jolting, and surging on his left side when turning the deep brain stimulator on and off. The left extension and bilateral deep brain stimulators were replaced in 2008, (please reference manufacturer's report # 3004209178200805581). The patient experienced initial improvement and then further exacerbation of shocking sensation. When the new neurostimulators were turned four days later, the patient felt a shock with the 'beeper' at first. He then felt shocking with the 'beeper' off. The patient's walking was poor when the device was on; when it was off, there were no problems. The patient had no tremor. A skull x-ray was taken the following month, (results not reported). The hcp planned to replace the left lead the following month. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1213296
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« Reply #78 on: January 14, 2014, 10:48:47 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: morgan jc, sthi kd. A single-blind trial of bilateral globus pallidus internus deep brain stimulation in medically refractory cervical dystonia. Curr neurol neurosci rep. 2008;8(4):279-280. The purpose of this study was to evaluate the efficacy and safety of bilateral gpi dbs in the treatment of medication-resistant cervical dystonia. This was a 1-year, multicenter, prospective, single-blind study of bilateral gpi dbs in 10 patients with medication-refractory cervical dystonia. Reportable event: one patient had multiple adverse events. This patient suffered left ophthalmic division shingles, a small subdural hematoma, and a subtle hemiparesis evidence with ambulation, which resolved within 1 year of follow-up. See mfg report 2182207200805918.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1168092
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« Reply #79 on: January 14, 2014, 10:49:53 PM »

Model Number 7424
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: shuurman pr, bosch da, merkus mp, speelman jd. Long-term follow-up of thalamic stimulation versus thalamotomy for tremor suppression. Mov disord. 2008; 23(8 ): 1146-1153. Thalamic stimulation and thalamotomy for treatment of tremor due to parkinson's disease, essential tremor, and multiple sclerosis were compared in a randomized trial. The symptomatic and functional outcome was studied after 5 years of follow-up. Sixty-eight patients were treated (45 pd, 13 et, 10 ms) by thalamotomy (n = 34) or thalamic stimulation (n = 34). After 5 years, 48 patients were available for follow-up. Reportable event: five stimulation patients experienced gait and balance disturbance. See mfg report 2182207200805826.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1163555
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« Reply #80 on: January 14, 2014, 10:52:01 PM »

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 #81 on: January 16, 2014, 01:11:28 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: york mk, dulay m, macias a, et al. Cognitive declines following bilateral subthalamic nucleus deep brain stimulation for the treatment of parkinson's disease. J neurol neurosurg psychiatry. 2008;79(7):789-795. We investigated the cognitive, and psychiatric outcome 6 months after bilateral subthalamic nucleus deep brain stimulation (dbs) for the treatment of parkinson's disease (pd) using a disease control group. A total pts who underwent dbs were compared with medically treated pts with pd at baseline, and at 6 months for neuropsychological measures. Reportable event: one of the pts who underwent dbs converted to dementia over 6 months compared with none of the pd controls. This pt was a male who had been diagnosed with pd for 13 years. His wife reported confusion post-dbs that resolved after 2 wks and hallucinations that resolved after 8 wks. Six months following surgery, he experienced a marked improvement in his dyskinesias. While his "off" medication motor updrs score improved from 60 to 57 following surgery, his "on" score declined. He continued to experience freezing, and he had "drop attacks". Heis mmse score declined to 23/30. Memory, initiation, perseveration, fluency and both verbal and visual memory declined significantly. Mood remained consistent. See mfg report 218220705638.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159082
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« Reply #82 on: January 16, 2014, 01:12:24 AM »

Model Number 7428
Device Problems Implant, reprogramming of; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 06/04/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The health care professional indicated to the patient's spouse that there was a "disruption" when reading the ekg. After the ekg, the patient experienced a loss of therapeutic effect. The spouse stated the patient "could hardly walk after the ekg". The patient's stimulation was verified to be on. The next day, the patient was doing better. The patient was at home. The patient was encouraged to follow-up with his health care professional. In 2008, the patient reported that he visited his health care professional. His device was reprogrammed and his programmer was replaced. The patient was still having problems with his system. He was unsure if he would need surgery to fix the problem. He was also unsure if the problems were related to the implanted system. Additional information has been requested, 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=1159256
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« Reply #83 on: January 16, 2014, 01:13:06 AM »

Model Number 7428
Device Problems Device remains activated; Device remains implanted
Event Date 11/21/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, about twelve days prior, the patient detected a scab near the scar on top of their head and went to the physician to have it checked. The physician did an mri. The mri did not detect an infection, however, did show swelling. The patient was put on antibiotics for 12 days. In late 2008, the patient woke up unable to walk. The patient remained at home. The patient checked the device and it remained on. Additional information has been requested, but was not available on the date of this report.

 
Manufacturer Narrative
Product id 3389s-40, lot# v057193, implanted: 2008-(b)(6), product type lead.

 
Event Description
Additional information received reported the patient had surgery on 'bubble' in 2011. It was stated that there was a 'persistent anxiety' of infection; therefore a flap was surgically placed. No further information was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1276537
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« Reply #84 on: January 16, 2014, 01:13:54 AM »

Model Number 7426
Device Problems Implant, reprogramming of; Malposition of device
Event Date 06/13/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
The pt had an intracranial hemorrhage (ich) when the deep brain stimulator was initially placed. The pt had multifactoral gait instability secondary to the ich, neuropathy, and parkinson's disease. Please see mfg report # 3004209178200808571. The pt had a fall with loss of consciousness and broke his hip. The pt had hip surgery. A computerized tomography scan in 2008, showed that the right lead was out of place. The device could not be revised due to the ich. The left lead was in place. The pt was living in a nursing home. Multiple stimulation therapy adjustments were made without benefit. The pt had a similar response to therapy before the fall. The pt was getting tremor relief. The hcp attributed the fall to the ich and parkinson's disease and not to deep brain stimulation therapy. The hcp reported the pt outcome as serious injury - recovered with sequela. Please see mfg report # 3004209178200808575.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1273918
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« Reply #85 on: January 16, 2014, 01:15:24 AM »

Model Number 7426
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 10/01/2008
Event Type  Injury 
Event Description
It was reported the pt experienced a loss of efficacy and therapeutic effect. The symptoms started about one month prior to the report. The pt had difficulty walking. The pt was seen by the physician; it was determined that the device settings were not set right. The pt was reprogrammed but the pt still did not feel better. The pt was taking some oral medications. X-rays found no issues. A mri was scheduled for 2008. It was also reported the pt has increased weight at the time of the report, but was losing weight. The patient was at home at the time of the report and redirected to contact the physician. Additional info had been requested from the hcp, but was not available as of the date of this report. This event was also reported under mfr report # 3004209178-2008-08241.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1263304
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« Reply #86 on: January 16, 2014, 01:16:03 AM »

Model Number 7426
Device Problem Device remains implanted
Event Date 10/02/2006
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The pt had an intracranial hemorrhage (ich) when the deep brain stimulator was initially placed. The pt had multifactoral gait instability secondary to the ich, neuropathy and parkinson's disease. The pt had a fall with loss of consciousness and broke his hip. Please see mfg report # 3004209178200808572 and 3004209178200808575. The hcp attributed the fall to the ich and parkinson's disease and not to deep brain stimulation therapy. The hcp reported the pt outcome as a serious injury - recovered with sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1273922
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« Reply #87 on: January 16, 2014, 02:14:27 PM »

Model Number 7428
Device Problems Replace; Implant, reprogramming of; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 04/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt was scanned with a security wand at an airport. His deep brain stimulator was 'zapped'. The pt immediately became dizzy, felt sick to his stomach, and fell to his knees. Two hours later, he had recovered and flew home. Several days later, the dystonia muscle spasms treated by the device gradually returned. Two months later, the deep brain stimulator was interrogated. The tests showed that the stimulator, battery, and electrodes were fine. There was no power on reset reading or out-of-range impedances. The pt's health became worse. He was unable to go for long walks, had difficulty sleeping and eating. The neck muscle spasms were periodically getting worse. The pt increased the device output with his pt programmer but became worse afterward. There were no symptoms changes if the deep brain stimulator was on or off. The hcp tested the implantable system again several months later. The diagnostic tests showed that the device was working correctly. Two months later, the pt 'could barely function'. The hcp turned the device off and the pt felt better for a couple of days. While the device off, the dystonia symptoms were not as severe as they were prior to deep brain stimulation. Head and neck x-rays taken one month later showed that no wires were broken and that the connections were intact. The pt was having difficulty walking or doing any other activities. About 4 months later (one year after the airport incident), the deep brain stimulator was replaced. The pt felt much better afterward. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1248090
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« Reply #88 on: January 16, 2014, 02:16:51 PM »

Model Number 7426
Device Problem High impedance
Event Type  Malfunction 
Event Description
It was reported the pt had been experiencing a gradual loss of therapeutic effect (tremor control) on the left side and a change in gait. There was no known event related to the onset of the symptoms. The pt was seen in the clinic. Impedance readings were normal on the left side. The right side gave readings of >2000 omhs (0/case = 2000; 1/case = >2000; 2/case = >2000; 3/case = >2000; 1/2 = 1686; 1/3 = >2000). The pt was programmed at 2 volts, 120 pulse width, rate 185 and case 0. Reprogramming was attempted with one and two electrodes, but the symptoms worsened. An x-ray was being considered. Additional info has been requested, but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1278107
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« Reply #89 on: January 16, 2014, 02:19:17 PM »

Model Number 7426
Device Problems Replace; Low battery
Event Date 07/20/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted late due to a delay by a manufacturer employee. A process improvement plan and training are in place.

 
Event Description
The patient experienced no stimulation, a gradual return of tremor, freezing gait, and a fall while walking. The green neurostimulator battery light of the patient programmer was not lit. The patient was seen by his hcp. The right deep brain stimulator was replaced. The hcp reported the patient outcome as 'no injury'.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1250384
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« Reply #90 on: January 17, 2014, 11:57:28 AM »

Model Number 7426
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 11/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a lack of effect, shuffling gait and shoulder pain after a fall two weeks ago. The pt had add'l falls since the event. It was also reported the pt had a possible torn rotator cuff. The left shoulder felt pulling, left side of the face felt pulling, and pain in her left eye for the last two days. The pt was unable to adjust the stimulation. When the status lights were assessed, both batteries appeared good (lights on). The pain in the shoulder was described as acute pain. The ambulation difficulties included increased shuffling of her feet. The left part of the pt's face felt numb. It was also reported the pt had chest pains and an asthma attack while driving home the day before. The pt went to the er for the symptoms. An x-ray of the pt's shoulder was done. An ekg was performed. The physician had turned the device off to perform the ekg reading. A magnet was used to turn the device off, and back on following the ekg. The pt had reported a lessening of symptoms but the physician was unsure if the device was on. The pt was unable to ascertain if the left ipg felt better on or off. The pt's numbness and pulling on the left side of the face and pain over the eye, was reportedly worse when the device was on. The er physician planned to turn the left ipg off and leave it off until the pt could see their following physician. Add'l info has been requested. See also mfr report # 3004209178-2009-00057.


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« Reply #91 on: January 17, 2014, 01:13:04 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 01/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient had difficulty walking, leg weakness and paresthesias. The patient complained that after her most recent programming session her speech became like a whispering and she had fallen nine times. The patient was directed to contact to physician for a reprogramming consultation. Additional information has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer report # 3004209178200900227.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287241
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« Reply #92 on: January 17, 2014, 08:22:53 PM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease, experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1): 26-35. Summary: this study evaluated 42 patients from 2005 - 2006, to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. Patient underwent re-operation to reposition the electrodes, which were too medially located near or in the red nucleus. It was confirmed by the fused image of pre- and post- operative mri taken at 6 months after stn dbs. Patient had not experienced any improvement of symptoms with dysarthia and gait difficulty. Also, his mri 5 months after surgery demonstrated that the dbs electrodes were positioned off the stns. The right sided symptoms of the patient were dramatically improved after the revision surgery. See manufacturer report number: 2182207200902211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353062
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« Reply #93 on: January 17, 2014, 08:23:47 PM »

Model Number 7426
Device Problems Dislodged; Low impedance
Event Type  Malfunction 
Event Description
It was reported the patient experienced a loss of therapeutic effect (increased difficulty walking). There was no known event related to the onset of the symptoms. The patient was seen at the clinic. The patient was in good status. Impedance values were taken. Some of the readings were low. In january group impedance values were 449 ohms. The lead/extension connection had slid down lower in the neck. It was suspected there could be damage in this area. Further troubleshooting was being considered. Additional information has been requested but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1395025
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« Reply #94 on: January 17, 2014, 08:24:56 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 10/23/2008
Event Type  Injury   Patient Outcome  Disability
Event Description
It was reported that the pt experienced no therapeutic effect and a change in gait with difficulty walking and leg weakness two days after lead implant. It was unk if the pt's symptoms were related to the implant or spinal stenosis. Additional testing was pending. Additional info has been requested, but was not available as of the date of this report. Reference mfr. Report # 3004209178200901277.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325823
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« Reply #95 on: January 17, 2014, 08:27:08 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: strecker k, meixensberger j, schwarz j, winkler d. Increase of frequency in deep brain stimulation relieves apraxia of eyelid opening in patient's with parkinson's disease: case report. Neurosurgery. 2008;63(6) e1204. A male diagnosed with idiopathic parkinson's disease, since the age of 48 years suffered from micrographia and general slowing of motion. Due to motor fluctuations, drug-induced hallucinations, and severe gait disturbance, the patient underwent implantation of a deep brain stimulator of the subthalamic nucleus in 2000 with a routine exchange 2003. The patient was seen at the clinic in 2004, admitted for recurred gait disturbance and freezing. He also had hypokinesia, moderate rigidity (more on left side), hypomimia, severe dysarthria including hypophonia. Device settings were adjusted with marked improvement of hypokinesia and rigidity and speech. Gait disturbance showed some response, but occasional starting hesitation still occurred. Although, the positive effect on speech was transitory, improvement of hypokinesia and rigidity persisted. Over the next year, the patient developed apraxia of eyelid opening (aeo) that gradually worsened. Attempts to reduce the amplitude caused a worsened hypokinesia and gait disturbance. However, an increase of the stimulation frequency to 180 hz resulted in a prompt and persistent relief of aeo. Paresthesia in both hands was noticed after the adjustment of frequency, but it resolved within minutes. Dysarthria was also partially ameliorated. To test whether this would persist with lower frequencies, we set the frequency to 160 hz. The patient was still able to open his eyes, but only with considerable effort. When the frequency was changed back to 180 hz, this symptom resolved.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324326
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« Reply #96 on: January 17, 2014, 08:28:08 PM »

Model Number 7426
Device Problem Replace
Event Date 02/19/2007
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
The patient experienced increased parkinsons symptoms and episodes of freezing. The deep brain stimulator battery voltage was changing, but not enough to merit a battery changeout. The voltage was around 3. 69 volts. The patient received information from a chat room that other patients had the device changed when the voltage got to this value and requested the change from the hcp. This was not the normal procedure for the physician, but as the voltage was changing the devices were replaced in 2007. The patient got better and the freezing episodes stopped. Please see mfr. Report 3004209718200901108.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1316335
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« Reply #97 on: January 18, 2014, 05:05:07 AM »

Model Number 7426
Device Problem Loss of power
Event Type  Malfunction  
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a loss of therapeutic effect. The patient stated they were more forgetful, could not walk very well, and that balance was bad. The patient experienced double vision and reported feeling like they were in a bubble. The patient reported that the implantable neurostimulator battery was at 35% and they were having "major problems". The patient also reported problem with the patient programmer. The patient noted that the implantable neurostimulator (ins) was turning on and off without warning. The patient stated they went to the er and the implantable neurostimulator was turned back on there, then it turned off again when the pt went home. The patient's physician informed the patient that their ins had been off for two weeks but the patient stated that the patient programmer never indicated this. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458868
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« Reply #98 on: January 18, 2014, 05:06:59 AM »

Model Number 7426
Device Problem Loss of power
Event Date 03/01/2009
Event Type  Malfunction 
Event Description
It was reported the patient was not able to adjust stimulation on the left device. The right side is not working, but there is no response on the left. Additional information received from the hcp noted the patient experienced ambulation changes. It was also noted the left device was "dead" after only 1 1/2 years at moderate settings. The left side device was scheduled to be replaced in 2009.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1424363
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« Reply #99 on: January 18, 2014, 05:08:39 AM »

Model Number 7426
Device Problem Loss of power
Event Type  Malfunction 
Event Description
It was reported that the pt experienced walking difficulty, speech difficulty, and a "dropped" mood. The pt's physician indicated during an office visit that the implantable neurostimulator had been off for approximately 2 weeks. Additional info has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425039
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« Reply #100 on: January 18, 2014, 05:10:33 AM »

Model Number 7428
Device Problems Extraneous radiofrequency wave transmission; Replace; Inappropriate shock; Implant, reprogramming of
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced worsened tremor. The deep brain stimulator was replaced due to battery depletion. At the clinic visit 1 week after device replacement, the pt experienced improved gait and slightly improved tremor control. The pulse width was increased resulting in complete tremor control to the left side of body. Mild to moderate tremor persisted in the right upper limb and occasionally right leg. The patient experienced right shoulder pain. The patient was treated with ropinirole xl and sinemet. At a clinic visit approximately 1 month later, the patient felt shocking when the device was turned on at an amplitude of 4. 0 volts. Impedances were greater than 4000 ohms on electrode combinations involving electrode #3. The tremor was well controlled at 4. 8 volts, but the patient had deteriorated, slurred speech. Therapy amplitude of 5. 7 volts controlled tremor, but caused right-sided tingling and increased slurring of speech. The pt experienced slight right-sided tingling at 4. 7 volts. At 5. 2 volts, the patient felt slight numbness to the left leg. The ropinirole caused facial dyskinesias. The device was reprogrammed to previous settings (as they were prior to generator replacement). The patient had better tremor control on the right body side on lower settings. The patient's postural stability was similar to that before increasing the settings. The patient's speech was less slurred, but slow at times. The patient ambulated with slow, small steps. The patient's condition was not able to be stabilized with reprogramming. The deep brain stimulator was replaced (b)(6) 2009. The patient was doing well with the new stimulator at the original settings. The nurse mentioned that there was.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370871
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« Reply #101 on: January 18, 2014, 02:55:26 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/30/2009
Event Type  Malfunction 
Event Description
See mfr # 3004209178200903232. It was reported that since the pt fell on his hands and knees; he has experienced difficulty walking and a return to more dyskinesias. The pt was at home in fair condition. Further info is being requested from the hcp.

 
Manufacturer Narrative
(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458566
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« Reply #102 on: January 18, 2014, 02:59:58 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 11/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Following a revision (see manufacturer's report # 3004209178200901474), the patient's balance was not as good and he was having problems with walking. During a follow-up visit, they discovered a "pool of blood" in his head and the patient had to have another surgery. The physician prescribed pt (physical therapy); it worked slightly and was only temporary. The patient was unable to do things that he used to do and he was unable to take care of his wife. The implantable neurostimulator (ins) had not been reprogrammed since implant. Follow-up with the patient's healthcare professional was recommended to see if reprogramming might help to improve his balance and walking issues. Additional information has been requested, 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=1376417
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« Reply #103 on: January 19, 2014, 01:11:27 AM »

Model Number 7426
Device Problem Replace
Event Date 04/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Freezing.

 
Event Description
It was reported that the patient visited their physician with "freezing. " the physician decided to replace the implantable neurostimulator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1393151
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« Reply #104 on: January 19, 2014, 01:13:46 AM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a lack of therapeutic effect since the time of the implant and felt the symptoms had gotten worse over the past month. The patient symptoms were; dizziness, balance issues, trouble with speech, walking, has stiffness/rigidity, double vision, freezing constantly, weakness, and fatigue. The patient did note that he had been dizzy for the past two years. The patient stated the tremors in the right arm were worse now than before implant. The patient reported a shocking or jolting sensation every time he turned on his "lower: ipg. This resulted in a headache and "racing of heart". The device was turned off and the symptoms were gone about 2 hours later, but the patient's tremors in his right hand returned. Multiple attempts at reprogramming had been unsuccessful and the patient was requesting the leads to be explanted. Please see mfr. Report# 3004209178200904365. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1407420
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« Reply #105 on: January 19, 2014, 01:15:45 AM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
Two days after an extension revision (see mfrs report #s 3004209178-2009-04335 and 3004209178-2009-04336), the pt had neurological deficit symptoms which included being very rigid and immobile on the left side and the pt had speech changes. The pt had no stimulation and new pain in his left neck and chest. Impedance measurements were checked and some of the bipolar pairs were reading >4000 ohms (c/4, 4/6, 4/7). The default test values were increased to 3v and impedances measurements were as follows: 4/7>4000 ohms; c/4-2815 ohms <15 ua; 4/6-2815 ohms <15ua. The pt was programmed 4+, 5-, 6-. Even with reprogramming, the pt could only open and close his hand where as before he could walk. They were going to take an x-ray to see if they could see anything wrong with the lead. A revision was being considered. The pt's outcome was reported as "no injury". See mfr's report # 3004209178-2009-04341.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1465438
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« Reply #106 on: January 19, 2014, 06:17:17 PM »

Model Number 7426
Device Problem High impedance
Event Date 01/01/2008
Event Type  Malfunction 
Event Description
It was reported that the patient had multiple falls since october of 2008. The patient experienced a loss of efficacy (which was claimed to be unrelated to stimulation therapy) and impedances >2,000 ohms. An x-ray of the lead area revealed no lead breaks. Additional information revealed that the patient experienced "fizzy" feelings of the head and double vision along with difficulty walking with electrode 1 programmed. The following impedances were measured: c0:721 ohms 74ua, c1:>2,000 ohms <7ua, c2:721 ohms 74ua, c3:714 ohms 74ua, 01:>2,000 ohms <7ua, 02:1113 ohms 55ua, 03:1109 ohms <51ua, 12:>2,000 <7ua, 13:>2,000 ohms <7ua. Additional information has been requested, but was not available as of the date of this report.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471574
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« Reply #107 on: January 19, 2014, 06:19:06 PM »

Model Number 7428
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Impedance problems - other: dystonia.

 
Event Description
It was reported that following a revision, the patient experienced a loss of therapeutic effect; dystonia was worse, cognitive changes, gait instability, and a fall. A ct scan showed no problems. Problems with impedances were reported. Channel one was ok. Channel two was questionable. Four and case, seven and case = 690 ohms with current less then 15. All bipolars = 690 ohms with current less then 15. 5 & case and 6 & case = 452 ohms with current greater than 19. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1400256
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« Reply #108 on: January 19, 2014, 06:20:39 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury 
Manufacturer Narrative
 
Event Description
See manufacturer # 3004209178-2009-05525. It was reported that right after the pt was implanted, she developed an imbalance and unsteady gait. Prior to stage 1 implant, she had no issue and did not use a walker. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1443495
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« Reply #109 on: January 19, 2014, 06:22:19 PM »

Model Number 7426
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that since implant the patient has been running when trying to walk. Following reprogramming the patient could walk for 4-5 days. But then the running returned. When the ins was turned off in 2005 the patient walked well. A lead revision was done in 2006 with no improvement. The device worked well to control the patient's tremors. It was noted that the patient fell and broke his arm and ribs (timeline not specified). Further information is being request from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1447235

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« Reply #110 on: January 20, 2014, 12:56:10 AM »

walking

Model Number 7428
Device Problem Device remains implanted
Event Date 06/03/2009
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention
Event Description
It was reported the pt experienced a sub-dural hematoma which required surgical treatment. The procedure involved drilling dual ipsilateral burr holes. No dbs product was removed. Add'l info received indicated the cause of the event was unk. The pt experienced ambulation changes, cognitive changes, and speech changes. Initial and follow up programming were done two times in 2009. The pt obtained very good bilateral tremor control with no side effects. A ct scan performed on the second day, indicated a left subdural hematoma. On the following month the pt underwent burr hole drainage. The pt did well but had a re-occurrence fluid collection but no hematoma. The pt was discharged to rehabilitation with general deconditioning. The pt status was improving. Discharge summary notes indicated the pt is a male with a history of essential tremor who underwent bilateral dbs placement two months prior. The pt initially did well, but subsequently developed difficulty with word finding and general unsteadiness. He was imaged at the time of presentation and was noted to have a large left-sided chronic subdural hematoma. The pt was taken to the or for evacuation via a burr hole. He did well and was discharged the following day. At discharge the pt was neurologically intact, speech was improved, and the wound was clean. Since that time, the pt complained of overall fatigue increasing over a few days. The pt had also had recurrence of his word finding difficulty and remained unsteady on his feet. He denied headache, weakness, fevers, or seizures. His son brought him to the er to be evaluated eleven days after burr hole drainage, where another head ct showed recurrence of the subdural hematoma and concern for mass effect causing his symptoms, as they were similar to those of his initial subdural hematoma. After further review of the ct, the pt was found to have a subdural hygroma with pneumocephalus with no evidence of recurrent hemorrhage or significant mass effect. He had no acute focal neurological deficits and had chronic generalized symptoms related to his age and deconditioning. He was admitted the same day, started on keppra for possible seizure activity, and his neurologic status was monitored closely. The pt was evaluated by the physical nad occupational therapy staff who recommended inpatient rehabilitation.

 
Manufacturer Narrative
Used for speech changes (no) and unsteadiness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1410535
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« Reply #111 on: January 20, 2014, 04:45:53 AM »

Model Number 7428
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient's battery was failing; it was at the critical failure point. The patient had "decompensated to pre-implant levels"; he was in a "very bad state". The patient underwent surgery. At follow-up, the physician attached a device to the "wires of the battery" but was unable to adjust anything. It was felt that the physician did not know how to adjust the battery. The patient had difficulty walking, sleeping, and articulating his thoughts. The patient saw another physician located over two hours away from his home and was told he would need to return every two weeks for six months to adjust the battery. The outcome is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566202
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« Reply #112 on: January 21, 2014, 04:49:35 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 rigidity, bradykinesia, dyskinesia, and tremor, but persistent 'on' dystonia, freezing of gait, and dysarthria. The lead was determined to not be optimally placed. Following unilateral lead revision the pt had improved dystonia, freezing of gait, and dysarthria and no adverse effects.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562488
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« Reply #113 on: January 21, 2014, 05:01:30 AM »

Model Number 7426
Device Problem Device operates differently than expected
Event Date 05/01/2009
Event Type  Malfunction 
Event Description
The patient had experienced several falls since having a seizure in (b) (6) 2009. Afterward, was unable to walk and talk while deep brain stimulation was on. When stimulation was turned off during a colonoscopy, he was able to speak. He was also able to walk without falling when it was off. Please see mfr report #3004209178200909121. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1563072
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« Reply #114 on: January 21, 2014, 05:06:38 AM »

Model Number 7426
Device Problem No Information
Event Date 06/29/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported the patient experienced a catatonic contraction with her head and shoulder - leaning to the right. The hcp felt that the patient experienced an element of dystonia in the neck area that was not present prior to the implant. The muscle contractions were significant enough that it was interfering with the patient's gait, and has caused her to fall several times. A botox injection improved things slightly. The patient's device was reprogrammed and had another reprogramming appointment scheduled for the following week. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1563088
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« Reply #115 on: January 22, 2014, 08:59:36 AM »

Model Number 7428
Device Problems Device operates differently than expected; Impedance issue
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, the pt was moving very slowly. There was a problem with the impedance values. The pt was referred for a consult and possible adjustment. Add'l info received indicated, the event was suspected to be attributed to the location of the lead. The cause of the event was unclear; but may be related to the programmed settings. The pt experienced cognitive changes, flat affect, and symptoms of early dementia. Reprogramming was done. A contact was deleted in the superior zona incerta region to improve the patient's gait. A prescription for galantamine was added. Office notes indicated, the pt festinated in small spaces. The pt had fallen, however, walked ok when out and about. In 2009 at the time of the visit, the pt had a good long stride, good bilateral arm swing, fair balance on pull testing. The pt was very hypophonic. Contact 7 was deleted during programming, as the pt may have had worsening of his gait from this contact. It was initially added to control stim related dyskinesias, but perhaps those had since resolved or were less bothersome. It was reported over the last 9 months, the pt had multiple falls (>15). The pt reported having difficulty moving around for quite awhile, however, it had gotten to the point his feet buckle and he can't regain balance and falls over if there is nothing to catch him. The patient denied any precipitating factors or patterns. The pt denied any lightheadedness, dizziness, palpitations, mental lapses, loss of consciousness, or feelings of weakness associated with the falls. The pt reportedly broke a ribe during one of the falls and that he temporarily lost consciousness (10 seconds) during another episode where he fell in a parking lot. The pt had no residual pain/problems related to the falls. The pt also presented with worsening cognitive decline. The pt and his wife believed his memory was declining and he got confused easily, both of which had gotten progressively worse for the last 6-8 months. The pt had a "depressive mood" which was being treated with venlafaxine, which his wife describes as a lack of motivation. The pt reported he "feels terrible" but was unable to describe the symptoms further. Along with his wife, the pt questioned if it was related to worsening pd or if this was a new problem. No functional problems were reported with the dbs unit, however, a technician had indicated the unit was not working as "efficiently as it could. " the pt's cognitive symptoms were consistent with the onset of dementia seen in pd. Given the new onset, the pt was recommended to start on galantamine and monitor for response. The pt also underwent changes to medications for the depressive symptoms. Medications: sinemet, venlafaxine, allopurinal, asa, simvastatin, lisinopril, vit b12, docusate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580214
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« Reply #116 on: January 23, 2014, 10:24:23 AM »

Model Number 7424
Device Problem High impedance
Event Date 01/01/2008
Event Type  Death   Patient Outcome  Death,Hospitalization
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: dilorenzo dj, jankovic j, simpson rk, takei h, powell sz, long-term deep brain stimulation for essential tremor: 12-year clinicopathologic f/u. Mov disord. 2010;25(2):232-238. Summary: this article describes the clinical course and postmortem pathological finding in a pt with et treated with dbs for 12 years. This (b) (6) woman had a 13 year history of progressive et prior to implantation of bilateral dbs electrodes in the region of her vim thalamic nuclei in 1996, producing immediate relief of arm tremor. Histopathological examination of the brain, performed 12 years after the initial implantation, demonstrated electrode catheter tracts rimmed by 20-25 micron sheath, with multinucleated giant cells and reactive gliosis. Lymphocytic infiltration was seen by l26 immunoreactivity with cd3 (t cells) staining predominating over cd20 (b cells). Cerebellar axonal spheroids and purkinje cell loss were found. The minimal foreign body reaction and gliosis around the electrodes 12 years after implantation supports the long-term safety of dbs. Event: the pt's most recent stimulation parameter adjustment was on (b) (6) 2008. The right side impedance values were normal. Left side impedance values were >2000, >2000, 1,400, and 1,834 ohms with respect to the case, respectively, for electrodes 0 to 3. From these last measurements, left electrodes 0 and 1 may have been fractured. Although, the pt's tremor amplitude was at least 75% lower with the dbs turned on compared to that with the dbs off, she developed postural instability which confined her to a wheelchair. In (b) (6) 2008, she was admitted for physical therapy for muscle disuse atrophy, but was discharged after 6 weeks with minimal improvement. She died in her sleep on (b) (6) 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692688
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« Reply #117 on: January 23, 2014, 10:25:25 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/01/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description
Literature: fytagoridis a, blomstedt p. Complications and side effects of deep brain stimulation in the posterior subthalamic area. Stereotact funct neurosurg. 2010;88(2):88-93. Summary: forty consecutive patients (67% men) operated with dbs in the posterior subthalamic area (psa) were analyzed for complications and side effects of the procedure. Twenty-seven patients had essential tremor, 8 had parkinson's disease, 2 had dystonic tremor, 1 had cerebellar tremor, 1 had neuropathic tremor and 1 writer's cramp. The mean age at surgery was (b) (6). The pts were followed for a mean time of 34 months (range 3-59). All procedures were performed by one surgeon during the period 2004-2008. Fifty-four dbs leads were implanted in these 40 patients, requiring a total of 57 tracks. Twenty-nine patients were operated in the left hemisphere, 7 in the right and 4 bilaterally. Four patients received an extra ipsilateral electrode in the psa due to an ambiguous response during perioperative stimulation of the original electrode. The pts were hospitalized for a mean of 7. 4 days (range 2-15). Event: a (b) (6) pt developed a mild contralateral hemiparesis after the operation. No hemorrhage or other findings of interest were seen on repeated ct scans. The hemiparesis had regressed completely at the eval after 6 months, but the pt experienced dizziness when standing up, forcing her to use a walking support when walking outside the home. The symptoms were not improved by turning the stimulation off. See literature article with mfr report #3007566237-2010-03700.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676372
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« Reply #118 on: January 23, 2014, 10:28:54 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/12/2010
Event Type  Injury   Patient Outcome  Other
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 global worsening of their parkinsonism (freezing) with ppn stimulation. See literature article with mfr report #3007566237-2010-02940.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658298
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« Reply #119 on: January 25, 2014, 03:46:29 PM »

Model Number 7426
Device Problems Electro-magnetic interference (EMI); Device operational issue
Event Date 06/01/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that a loss of therapeutic effect had occurred. It was reported that the pt's symptoms had reverted back to since before her implant, in addition to having experienced symptoms worse than ever before. Symptoms noted were stiffness/rigidity, and that the pt could barely walk. Pt believed the device was inadvertently turned off by "the fridge". It was noted that the pt "currently only uses the magnet". The pt visited her hcp for device reprogramming, and was told "that 1 device was off 55% of the time and the other device was off 60% of the time". Reference mfr report # 3004209178201005612.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766826
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« Reply #120 on: January 26, 2014, 03:09:00 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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« Reply #121 on: January 26, 2014, 03:10:19 AM »

Model Number 7428
Device Problem Connection issue
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: alcindor d, oh my, baser s, angle c. Cheng bc, whiting d. Stimulation of the globus pallidu internus in a patient with dyt1-positive primary generalized dystonia: a 10-year follow-up. Neurosurg focus. Aug 2010; 29(2):e16. Summary: in this case report, the authors describe a (b)(6) old man with dyt1-positive dystonia who underwent bilateral gpi dbs and report the 10-year safety and efficacy data. The patient had 10 left ipg changes on the more symptomatic side due to higher voltage needs and 5 ipg changes on the right over 10 years. Within 3 months of stage 1 surgery, the patient experienced a dramatic improvement; they were able to return to school and function independently. Minor symptoms experienced included mild dysarthria and a subtle rigidity while walking, none of which impedes daily activities. Reportable event: there were no significant complications, neurological deficits, infection/erosion, or system malfunctions. However, 4 years after initial ipg placement, the pt had increased rigidity and more cramping on the right side with the development of diaphoresis. In the left subclavicular ipg there were extremely high impedances, and chest radiography revealed disconnection of that generator. After revision surgery, these worsening symptoms resolved and the patient has had no further episodes of symptom recurrence.

 
Manufacturer Narrative
After 3 ipg changes in 13 months on the left side, a kinetra (7428) ipg was inserted. It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no add'l info was available, add'l info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885197
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« Reply #122 on: January 26, 2014, 03:11:53 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, 03:46:38 AM by dennis100 » Logged
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« Reply #123 on: January 27, 2014, 09:31:59 AM »

Model Number 37601
Event Date 08/09/2013
Event Type  Malfunction 

Event Description
It was reported the patient had their implantable neurostimulator (ins) replaced on the day of this report and they were shaking more than they were prior to implant. The reporter stated they were concerned that the patient¿s healthcare professional let the patient go home in that condition. The reporter further stated they were unable to use the patient programmer and did not know what needed to be done. It was noted the programmer showed 75% and ok. It was further noted the programmer showed stimulation was at 3. 09v and the patient was usually at 4. 3v and 4. 6v. Follow up information received from the healthcare professional (hcp) reported that the cause of the event was unknown and that impedances were normal. No surgical interventions had occurred and it was noted that the patient did not report any symptoms to the hcp regarding the event. It was unknown if hospitalization was required for the event. It was later reported that there was a loss of therapeutic effect. The patient was shaking and confused since the new implant was put in. It was noted that the patient was waking up in the middle of the night and asking questions about surgery that had already been discussed with the patient. The patient was scheduled for back surgery on (b)(6) 2013 and would be there for a little while. Patient was implanted but was not reprogrammed till a while later due to the patient being in and out of surgery. Patient had met with the manufacturing representative once and had some reprogramming done. The display was showing a ¿call your doctor¿ icon. There was an out of regulation (oor) condition. It was noted that when using the patient programmer to make changes was when the oor icon was showing up. Patient was unable to adjust stimulation. Additional information received reported the patient¿s battery was not turned on after battery replacement. It was noted that the manufacturing representative met with the patient and turned him back on with improvement in his tremor. Device was not related to the event. The date of the new implant was (b)(6) 2013. Patient was put back on his usual settings. Patient outcome was tremor improvement. It was noted that the date of onset was after the patient¿s rotator cuff surgery in (b)(6) 2013. Diagnostics were performed on (b)(6) 2013 and very high impedances were found at contact 1 on the left electrode. The cause of the issues was unknown though he had undergone shoulder surgery in (b)(6) 2013. Interventions taken were that the plus contact was switched from 1 to 2 on (b)(6) 2013. The patient had immediate improvement in right hand tremor and was requiring less voltage. Ins was changed in (b)(6) 2013. Patient had his l4 and l5 surgery on (b)(6) 2013 and was still recovering. Patient never had physical therapy for it and was doing arm exercises with more than the recommended 2 pounds. Since rotator cuff surgery the patient¿s right hand tremor had been worse. It was noted that the adjustment had helped some. It was noted that the patient was using a walker on (b)(6) 2013. Patient had normal facial expression, blink rate, voice volume w/mild tremor. Normal speed of gesticulations. The patient had minimal postural tremor in left hand and more prominent in the right and moderate. Trunk had some mild titubation exacerbated when standing or walking because of leg pain. Patient¿s gait with the walker was normal but had a decreased stride length and looked uncomfortable. It was noted that the night prior to this report the patient had shooting pain down his legs but no longer had that. Therapeutic impedance was high on left side. Postural tremor of right hand was minimal. Patient was able to hold a mug steady with minimal tremor after programming change. Left leg pain appeared better since the surgery on the day prior to this report. It was noted that since 2010 face/head injury and punch to abdomen and (b)(6) 2010 battery change the deep brain stimulator had never provided him with as good of relief as when initially implanted. It was noted that it was somewhat better after replacement on (b)(6) 2012. Patient felt it still was not as good as when it was initially implanted in 2006. Patient had various types of trauma that could have potentially damaged the deep brain stimulator. 0 contact was still best one after exploration of left electrode contacts. In the past the patient had some motor cramping/tightness on his left face and hand when his pulse width was increased to 90. On (b)(6) 2013 reported the patient went into the healthcare professional on (b)(6) 2013 with worsening of left leg pain. Patient had chronic back pain that had started about 10 years prior to this report. The patient had been in 5 motorcycle accidents and played hockey in high school with a number of hits and concussions. Patient also had concussions in his military years in his 20¿s. The patient¿s radiation of pain was more of a muscle spasm and cramping in the posterior and anterior thigh and had some numbness in the soles of both feet. There were no bowel or bladder problems. There was some tingling in the palms of his hands. There was no weakness in the hands or legs. The patient had some right shoulder issues felt to be the rotator cuff which had not been responsive to shots. Patient had been getting injections of l3/4 and l4/5 on the left and l5/s1 on the right and had been getting them for the past year prior to this report. Gates was mildly wide based and unsteady looking but was also painful when walking or standing. Patient was unable to relax legs. The patient had a mildly decreased vibration sense in the toes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530979
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« Reply #124 on: January 28, 2014, 04:43:12 AM »

Model Number 37602
Event Date 08/29/2012
Event Type  Death   Patient Outcome  Death,Disability
Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: 2012-(b)(4), product type implantable neurostim ulator product id 3389-40, lot# j0320077v, implanted: 2003-(b)(6), product type lead product id 748240, serial# (b)(4), implanted: 2003-(b)(6), product type extension product id 3389-40, lot# j0320077v, implanted: 2003-(b)(6), product type lead, product id 748240, serial# (b)(4), implanted: 2003-(b)(6), product type extension, product id 37642, serial# (b)(4), product type programmer, (b)(4).

 
Event Description
It was noted that the patient died. It was further noted that the healthcare professional (hcp) was concerned that the implantable neurostimulator (ins)/therapy might have exacerbated the patient¿s condition. Patient passed away in (b)(6) 2012. Additional information received reported the date of the patient death was (b)(6) 2013. Additional information received reported that device was not explanted.

 
Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3389-40, lot# j0320077v, implanted: (b)(6) 2003, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 3389-40, lot# j0320077v, implanted: (b)(6) 2003, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Event Description
It was reported that after the battery replacement the patient had deteriorated faster. The patient had needed a wheelchair following the change out whereas he was walking prior to the battery change out. It was noted that the patient¿s resting tremor was worse on the right side after the battery was changed out. Impedances greater than 40,000 ohms on left side were seen after battery change out, on (b)(6) 2012. It was noted that the patient had the same settings at the time of this report as they were prior to the change out. Therapy impedance was high and current draw was low. Patient was seen on (b)(6) 2012 again and impedances on the left side were still high. Patient was seen on (b)(6) 2012 and impedances were high on the left side. Additional information received reported no malfunctions were seen and no cause of the issue was determined. Reference manufacturer's report number: 3004209178-2013-23367 information omitted, see related pe¿s (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3513842
« Last Edit: February 04, 2014, 03:46:55 AM by dennis100 » Logged
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« Reply #125 on: January 28, 2014, 04:44:10 AM »

Model Number 7428
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient was implanted on 2010 (b)(6) and after the operation, the patient could not walk. It was noted that the patient went to the hospital on 2012 (b)(6) and the health care professional advanced the electrode target for about 6mm. It was noted, the patient could then walk and after taking pills, the symptom improved. The reporter noted that the patient went to the hospital for programming. It was noted that the product remained for about two months. It was further noted that a programming had been arranged on 2013 (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3506469
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« Reply #126 on: January 28, 2014, 04:45:20 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3519346
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« Reply #127 on: February 07, 2014, 12:18:42 AM »

Model Number 37612
Event Date 12/31/2013
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension (b)(4).

 
Event Description
It was reported, the patient had one side of the deep brain stimulator (dbs) turned on 2013 (b)(6) and the patient was doing ¿very very well¿ and they could understand when the patient talked and the patient could talk perfectly. It was stated, the patient¿s second side was turned on 9 days prior to report and ever since then the patient had problems. It was noted, the patient was stumbling and they used a walker to help them and they had an awful time navigating. It was stated, the patient would babble. It was noted it was hard to understand the patient. It was stated, the patient would babble and it ¿was like the patient had a stroke. ¿ it was stated they did not think the patient had a stroke. It was stated when the second side was turned on the patient fell at the health care professional¿s office. It was stated, the patient was weak and falling again. It was noted, the stimulation was turned down until the patient felt better and steadier on their feet and would not stumble. It was noted, the patient programmer did not have the ability to increase stimulation but only decrease. It was further reported, the cause of the event was possible effect of the programmer 1-2 weeks after the patient was seen. It was stated, the patient had fallen and tore their rotator cuff. It was noted, the patient fell 1-2 weeks after reprogramming of the dbs. It was stated, the patient was ¿all over the place¿ with movements on their right side and problems with speech, balance, and hallucinations. It was stated, the patient as seen by their family physician on 2014 (b)(6) who had questioned whether it was untoward affect from dbs and or the medication. It was stated, the patient¿s left side settings were decreased. It was noted, the patient¿s medication was also discontinued. It was stated no x-rays were performed. It was noted, the patient as to be seen on the day of report for reprogramming but it was cancelled due to poor weather. It was stated, the wife had rescheduled the appointment for 2014 (b)(6). It was noted the symptoms of jerky movement and affected speech had resolved. It was stated symptoms associated with the event were hyper-movement of left side, speech decreased, and hallucinations. It was stated, the patient sustained torn rotator cuff after fall. It was noted, the patient outcome was non-serious injury or illness. It was stated 2014 (b)(6), the patient was doing well. It was stated, the patient was able to feed themselves. It was stated the patient dressed with minimal assistance and they could put their jeans on. It was noted their speech improved and they were mentally clear. It was stated the patient had a walker that they would use inconsistently.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595012
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« Reply #128 on: February 07, 2014, 08:48:00 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative
Product id 37602, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 748351, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# unknown, implanted: 2013 (b)(6); product type lead product id 3387s-40, lot# va01mbs, implanted: 2012 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

 
Event Description
It was initially reported (b)(6) 2013 that therapy had been effective in treating the patient¿s tremors but it made walking more difficult. The patient was very disappointed with the results of deep brain stimulation therapy and since having her first implant on 2012 (b)(6). The patient has had difficulty walking without a walker and after the second implant on 2013 (b)(6) the difficulty walking got worse. The patient had 4 falls yesterday and fell almost every day. It was noted, the patient was taking less medicine and her health care provider (hcp) considered therapy a success. It was later reported on (b)(6) 2013 that the patient had ¿bad¿ results with the device therapy for parkinson¿s. She falls ¿all the time¿ and she was ¿very unstable¿. The patient wanted a list of physicians since her hospital did not seem to want to change her programming. It was further reported that the patient was still having concerns but was working with her hcp/company representative. The patient had an upcoming appointment on 2013 (b)(6). Additional information received reported the patient never had therapeutic effect. The patient was disgusted with the results of her deep brain stimulation (dbs) procedure; she was disgusted that her condition did not improve and it got worse. The patient could hardly walk, could not stand up, and her voice was bad. The patient walked into surgery and was now in a wheelchair. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3555091
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« Reply #129 on: February 07, 2014, 08:52:12 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/19/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Issar, n. M. , hedera, p. , phibbs, f. T. , konrad, p. E. , neimat, j. S. Treating post-traumatic tremor with deep brain stimulation: report of five cases. Parkinsonism <(>&<)> related disorders. 2013;19(12):1100-1105. Summary: post-traumatic tremor is one of the most common movement disorders resulting from severe head trauma. However, literature regarding successful deep brain stimulation (dbs) treatment is scarce, resulting in ambiguity regarding the optimal lead location. Most cases support the ventral intermediate nucleus, but there is evidence to defend dbs of the zona incerta, ventral oralis anterior/ posterior, and/or a combination of these targets. We report five patients with disabling posttraumatic tremor treated with dbs of the ventral intermediate nucleus and of the globus pallidus internus. Patients were referred to the vanderbilt movement disorders division, and surgical intervention was determined by a dbs multidisciplinary committee. Standard dbs procedure was followed. Patients 1e4 sustained severe diffuse axonal injuries. Patients 1e3 underwent unilateral ventral intermediate nucleus dbs for contralateral tremor, while patient 4 underwent bilateral ventral intermediate nucleus dbs. Patients 1e3 experienced good tremor reduction, while patient 4 experienced moderate tremor reduction with some dystonic posturing of the hands. Patient 5 had dystonic posturing of the right upper extremity with tremor of the left upper extremity. He was treated with bilateral dbs of the globus pallidus internus and showed good tremor reduction at follow-up. Unilateral or bilateral dbs of the ventral intermediate nucleus and bilateral dbs of the globus pallidus internus may be effective and safe treatment modalities for intractable post-traumatic tremor. Further studies are needed to clarify the optimal target for surgical treatment of post-traumatic tremor. Reported event: one (b)(6) male patient with deep brain stimulation (dbs) for post-traumatic tremor experienced moderate tremor reduction with some dystonic posturing of the hands. The reporter stated that the patient experienced stimulation-associated side effects including some dystonia movements of the upper extremities, gait instability, balance difficulties, paresthesias, ataxia while walking, and slurred speech. The reporter stated that the patient experienced decreased tremor control and increased impedance between six and 33 months after dbs implantation. It was noted that the patient underwent exploration and interrogation of the dbs system with replacement of the extension wires, which resulted in significantly improved tremor reduction. The patient reportedly continued to have some dystonic posturing of both hands while performing fine motor tasks. The reporter stated that the continued dystonic side effects may require consideration of additional leads in the globus pallidus internus (gpi) for increased tremor reduction. 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=3571891
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« Reply #130 on: March 28, 2014, 12:41:25 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id: 3389s-40, lot# va0753z, implanted: (b)(6) 2013, product type: lead. Product id: 3389s-40, lot# va0753z, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer. Patient product id: 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

 
Event Description
It was reported the patient experienced a loss of therapeutic effect; her tremors were okay but her handwriting had gotten worse which started in the last month or so. The patient¿s husband was told by the patient¿s physician that he could increase the voltage. It was noted the patient had developed lung cancer. Additional information received; approximately 2. 5 weeks later reported, the patient wanted to increase stimulation. The patient¿s husband saw ¿2. 10 then some bars and then 0. 80. ¿ he then saw 2. 99 volts after going to the navigator keypad. It was noted the patient was having problem on both sides. Additional information received reported that the patient was reprogrammed and was a lot better but were going in again to have it tweaked a bit more. The reporter noted there was no device issue. The patient was doing well. It was reported that the patient just had the device reprogrammed and wanted to know how to change groups. Basic functionality of the device was reviewed. The patient changed groups and stated out loud that there was ¿a tingling¿ in their hands. The patient wanted the manufacturing representative to stay on the line until it stopped. After a moment, the patient stated it was ¿calming down. ¿ the patient noted that they would try the setting. It was later reported that the patient had the deep brain stimulator for essential tremor and ¿it had worked great for what it was put in for. ¿ the patient was having some ¿side effects. ¿ the patient had terminal lung cancer. It was noted that the patient ¿she could not walk¿ if the implantable neurostimulator (ins) was on. If the ins was turned off and back on the patient got a shock and the patient had been told that this normally did not affect muscle control until a voltage of 6. It was noted that the patient was at 2. Several months prior to the date of this report, may be in (b)(6), the patient had reprogramming session that had taken 1. 5 hours. The patient had been absolutely exhausted after that. Patient¿s motor control had gotten worse since then. The patient had fallen 3 times on tuesday prior to the date of this report, once the day prior to this report and once the wednesday prior to the date of this report. It had created a problem with her foot and the patient was in a boot. Symptoms had occurred several months prior to the date of this report. The patient had seen the healthcare professional 2 weeks prior to the date of this report and after he had found out about the lung cancer he said to turn the ins off if it did not work. Patient¿s husband stated that ¿we know it was caused by the device. ¿ additional information was requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3647137
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« Reply #131 on: March 28, 2014, 12:42:59 PM »

Model Number 7428
Event Date 06/15/2013
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported, the patient had been implanted on (b)(6) 2013 to treat parkinson's disease. On (b)(6) 2013, the patient went to the hospital for reprogramming due to "leg ache and weakness", and difficulty to take a step and falling down easily. It was reported on (b)(6) 2013, the patient fell down and fractured a hip, so the patient went back to the hospital for treatment. It was reported, the patient had a limb tremble on (b)(6) 2013, and went back to the hospital for reprogramming and that improved the symptom (limb tremble). It was noted the difficulty taking steps and falling down easily were not improved. It was reported, the patient's health care provider (hcp) indicated the target spot "deviation by mri checking". Additional information reported it was unknown if the patient had any further troubleshooting done.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3611043
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« Reply #132 on: March 28, 2014, 12:43:45 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id: 7436, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Event Description
It was reported in (b)(6) 2013 the patient had experienced a cerebral hemorrhage. It was noted after the event the patient had experienced a ¿lisp, dribble automatically, and movement inconvenienced. ¿ it was noted on (b)(6) 2014 the patient had tried to turn on the product but the patient found there was no alarm sound when they clicked open the bottom. On (b)(6) 2014 e1a (rep): it was further clarified the patient continued to have dribbling, a lisp, and walking difficulty when they would try to move.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3636927
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« Reply #133 on: March 28, 2014, 12:44:35 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported the patient had their first programming episode in the doctor¿s office and they had a good response with mobility but they also complained of nausea. It was noted the patient had a lot of nausea, discomfort, and ¿lots and lots of dyskinesia,¿ especially freezing and ¿hypernicity. ¿ it was noted the health care professional (hcp) ¿backed it way down again¿ and then incremented it up but the side effects never went away. It was stated the patient¿s nausea and abdominal fullness and gassiness got worse and worse. It was noted the patient saw their hcp on (b)(6) 2013. It was noted they had tried several different sites. It was noted at the beginning of (b)(6) 2014 the patient did not have any dyskinesia but their movement ¿wasn¿t terrific and they still had a lot of freezing, horrendous gastroparesis, bloated stomach, intestinal bloating after eating, miserable all of the time, and they constantly tried to have a bowel movement. ¿ it was noted the hcp did not think the vagus nerve was stimulated. It was noted after the patient took their medications, they had very slurred speech ¿like they were drunk¿ and they could barely walk. It was stated all of the patient¿s symptoms had gone on since (b)(6) 2013. It was stated the patient had constipation. It was noted the patient saw their hcp about every two weeks to adjust programming but it did not work well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3626743
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« Reply #134 on: March 28, 2014, 12:45:36 PM »

Model Number 3387S-40
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va0e81e, implanted: (b)(6) 2013, product type lead. (b)(4).

 
Event Description
It was reported the patient had meningitis following deep brain stimulation (dbs) lead implant in december. The patient presented at the hospital today with increased confusion and impulsivity. The patient was in a rehabilitation unit and was struggling. He went home and had a bunch of falls, was unoriented and he did not know where he was. It was noted the patient last saw his implant physician yesterday. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available. Refer to mfr report # 6000153-2014-00022 for the patient's other lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3629391
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« Reply #135 on: March 28, 2014, 12:46:46 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 37602, serial # (b)(4), implanted: (b)(6) 2011, product type implantable neurostimulator; product id 3387s-40, lot # v015069, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # v015069, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension. (b)(4).

 
Event Description
It was reported that after the patient¿s implantable neurostimulator (ins) was changed she immediately had trouble with her ¿left¿ ins. Within three months of the change out her movement disorder was ¿horrible. ¿ the patient recently visited a healthcare provider (hcp) who told her the ins had not been turned on for some time. The patient was doing tae kwon do prior to the change out, but was now confined to a wheelchair. The patient also stated that there was one instance where she was in the hospital and a manufacturer representative came out to look at her programming. This occurred somewhere between (b)(6) 2011. The representative activated the correct program and the therapy worked as expected for a while. When the therapy stopped working again recently, the hcp assumed there was another lead problem. Two days later it was reported that three months after replacement ¿something got worse and it was on the wrong channel. ¿ the patient then stated that the battery was dead and being replaced the day after the report. The neurosurgeon needed to see that the other battery was active and functional. Two days later it was reported that the reporter spoke to the patient over the phone and believed that after the replacement surgery in 2011 the batteries were not ¿renumbered. ¿ the reporter stated that another representative might have met with the patient and ¿numbered¿ the battery and reprogrammed, which resulted in her receiving effective therapy. When the reporter spoke to the patient on (b)(6) 2014 she only mentioned that she wanted her therapy resumed and no other issues. The reported believed that the batteries were either on end of service (eos) or elective replacement indicator (eri) so they just need to be replaced and was hopeful that would resolve the therapy issues. Additional information was requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3642714
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« Reply #136 on: April 10, 2014, 05:12:00 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that a patient¿s stimulation was ¿shutting down¿ and he was not feeling any benefit. It was noted that therapy stopped two days prior to the report. The reporter stated that the patient programmer was displaying ¿call your doctor¿ and out of regulation (oor). It was reported that the patient saw the message the previous evening and had contacted the doctor, who wanted to see the patient but not until (b)(6) 2014. It was noted that the patient tried the programmer and it was working. The patient saw ¿yes¿ and ¿ok¿ after pressing the check key and saw the lightning bolt. It was reported that the patient couldn¿t feel anything and usually felt stimulation. It was noted that the patient asked if one of the leads was broken. Two days later, it was reported that the patient wasn¿t able to adjust stimulation and there was an oor condition. It was noted that a manufacturer representative was asked to see the patient to evaluate the impedance reading. The left side showed 924 ohms and 7. 27 milliamps, and the right side showed 3030 ohms and 2. 243 milliamps. It was reported that the doctor interrogated the device and did not see any oor or other message on the clinician programmer. It was noted that the oor message was seen during the weekend when a cat walked or jumped across the patient¿s chest. It was reported that electrode 7 showed higher than the normal 1000 ohms and higher, but the patient was not using that electrode. On the right side, the patient was programmed with case positive, 6 negative at 6. 8 volts, 120 pulse width and 120 hz and rechecking therapy impedance showed 3014 ohms and 2. 255 milliamps. On the left side, the patient was programed with 1 positive, 2 and 3 negative at 6. 8 volts, 90 pulse width, and 120 hz and rechecking therapy impedance showed 924 ohms and 7. 273 milliamps. It was reported that the day of the report when the device was interrogated, the oor message was not seen. It was noted that the implantable neurostimulator (ins) was last charged on (b)(6) 2014, the battery showed 75 percent charge the day of the report, and the ins battery was lasting longer than before. It was reported that before the patient needed to charge every two days. The reporter stated that the patient was part of a voice study and had turned the stimulation off for an hour last week. It was noted that the patient had been keeping stimulation on, he was wheelchair bound, and he had been unable to walk since saturday. It was reported that the ins battery was at 3. 9 volts and impedance readings were the same with palpation or neck turning. Five days later, it was reported that there was an open circuit on the right lead and on (b)(6) 2014 there was a return of symptoms, the device was checked and it was turned off and at 20 percent charge. It was turned back on and charged fully. It was noted that there were no problems charging and it was charged to 100 percent. It was reported that a healthcare provider (hcp) verified that the device was on and charged but it didn¿t appear that the patient was getting any therapeutic response. The medical workup was negative and all impedances with electrode 7 appeared to be greater than 10,000 ohms. It was noted that the last therapy impedance done in (b)(6) was 791. The reporter stated that there was a possible open and medically they could not program with electrode 4. It was reported that they couldn¿t program around it and there was a possible revision. It was noted that the amplitude had always been around 6. 8 volts. A week later, it was reported that the cause of the event was unknown and was presumably attributed to the ins. It was noted that therapy impedance on the right hemisphere increased from 900 to 3000. It was reported that the ins issue was unknown and it was not delivering therapy. It was noted that an x-ray and ct scan on (b)(6) 2014-02-25 were normal and a time for ins replacement would be determined. Symptoms associated with the event included acute worsening of parkinson¿s disease symptoms and the patient didn¿t require hospitalization. It was reported that the event was ongoing and the patient symptoms were still not controlled until surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3671177
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« Reply #137 on: April 10, 2014, 12:44:41 PM »

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

 
Event Description
It was reported that the patient was implanted on the other side in (b)(6) 2012 and the right body trembled was not able to be controlled after the product was turned on. It was noted that the patient had gone to the hospital for reprogramming in (b)(6) 2012 but the right tremble had not improved. Patient had never gone to reprogramming later. The patient was now lying on the bed and was not able to walk or take care of herself. Additional information received reported the patient had never gone to the hospital for reprogramming after (b)(6) 2012. It was unobtainable if any further troubleshooting was done of if any actions had been taken.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3663411
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« Reply #138 on: May 11, 2014, 06:21:36 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that the patient experienced acousma before implantation. It was noted that the after implant the patient experience d ¿an intensity, doubtful, talk nonsense, walking quickly, and sound low. ¿ it was noted that a ct scan on 2014-(b)(6) showed that the patient effect was well and the patient was given some psychoactive drug. It was noted that on 2014-(b)(6) the patient went to a psychiatry clinic and the health care professional (hcp) there also gave some psychoactive drug and the effect improved. It was noted that on 2014-(b)(6) the patient did not recognize the family member and had gatism. It was noted that there was no patient injury or death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3721809
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« Reply #139 on: May 11, 2014, 09:39:30 PM »

Model Number 37601
Event Date 03/20/2014
Event Type Injury Patient Outcome Life Threatening
Event Description
It was reported the patient had their second deep brain stimulator (dbs) adjusted the day prior to report and the reaction to the programming had caused the patient to have walking issues and issues with their personality. It was noted they wanted to know if the use of a digital hearing aid was okay. It was noted the personality issues were specified as they ¿did not want to live and they wanted to kill themselves. ¿ it was stated the patient had gone back to their doctor¿s office on the day of report and the settings were turned back to how they were prior to the adjustment and the amplitude was also increased. It was stated the programming adjustment on the day of report had resolved the personality issues.
Manufacturer Narrative
Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer. Patient product id: 3389s-40, lot# va0bjs5, implanted: (b)(6) 2013, product type: lead. Product id: 3389s-40, lot# va0bjs5, implanted: (b)(6), product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3743947
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« Reply #140 on: May 12, 2014, 02:58:50 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).
Event Description
It was reported the patient¿s deep brain stimulation (dbs) device was implanted (b)(6) of 2012 and they could never program it. The leads were implanted and ten days later they put the battery pack in and they waited another ten days before they turned it on to program it. The patient¿s healthcare provider (hcp) could not figure out why on the lowest setting the patient could not talk, his left arm would come up to his chest when he would walk and his right shoulder kept twitching or spasming. From the time it was implanted the device did not really function for the patient; every time they turned it on and gave him medications to try to control the dyskinesia it did not work and this was after a year of oral medication. It was noted the patient was dyskinetic the entire time the device was implanted. It stayed in for about a year until they could not figure out why or what was going on. Every time the patient turned it on ¿patient shoulder would, he was falling three times a day. ¿ the patient fell in his house and broke his ribs the last saturday in (b)(6) 2012. The patient¿s dbs device was turned off and he was better but he still had some of the dyskinesia and had tremendous headaches. In (b)(6) of 2013, the patient had his device removed as he could not handle it anymore. The patient was sure there was a short circuit or something like that which caused the dyskinesia. It was reported the patient thought the leads down in the globus thalamus would not do that, he understood it may affect his speech, but not the rest of it. It was reported the device was leading to such headaches and such problems; he had a big bony growth behind his ear in his skull which was occurring during the entire time the device was implanted. After the device was removed those symptoms went away. Additional information received two weeks later reported somewhere around the second week of (b)(6) 2012 the patient was in severe dyskinesia one night and he could not turn it off. He did not know what was going on and he finally got in touch with a manufacturer representative from (b)(4) who walked his wife through turning his device off. It was also reported the patient¿s unit did not come out easily, the leads and all that stuff did not come out easily. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3745721
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« Reply #141 on: June 07, 2014, 10:13:17 AM »

Model Number 37612
Event Date 02/20/2014
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
(b)(4).
Event Description
It was reported that there were 1-2 bad electrodes isolated to one side of a bilateral deep brain stimulation (dbs) system. The patient was recharging often and there was high current drain with low impedance. The manufacturer¿s representative had met with the patient the day prior to report to perform impedance testing. Electrode impedances were as follows: c/0 745, c/1 734, c/2 952, c/3 1080, 0/1 44, 0/2 844, 0/3 1125, 1/2 844, 1/3 1125, 2/3 1035. The patient was currently in the hospital for bad gait and speech problems. The patient had been hospitalized for 10 weeks. Extensive reprogramming had been performed by the neurologist and only programming electrodes 0 and 1 seemed to help the patient. The patient was programmed on the shorted contact. It was stated that the patient¿s system was fine prior to hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3830617

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« Reply #142 on: June 07, 2014, 10:14:18 AM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported on (b)(6) 2014 that the patient had a loss of therapeutic effect that started suddenly ¿about three weeks ago. ¿ the reporter stated that the patient ¿all of a sudden was not walking well. ¿ the patient was taken into the clinic to check his system and it was determined that the implantable neurostimulator (ins) was not delivering any stimulation to the contacts. X-rays of the lead and extension were taken, but no issues were found. Left ins replacement was scheduled and completed. The patient was doing fine with no issues.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3824787
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« Reply #143 on: June 07, 2014, 10:15:14 AM »

Model Number 7426
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported, the patient was not able to use their hands. It was noted, the patient had pain, tingling, and numbness in their hands. It was stated, they had no mobility in their left hand and the left hand was worse than the right. It was noted, the condition had gotten progressively worse since (b)(6) 2013. It was stated they were unsure if the deep brain stimulator (dbs) still worked as it had been 4 years since their last battery change. It was noted they cortisone in their left hand at one time but it did not help. It was noted, the patient¿s condition ¿may not be due to the instrument itself. ¿ it was further reported, the patient had a loss of therapeutic effect. It was noted, the patient had fallen more than usual. It was stated in (b)(6) 2013, the patient had started to fall a lot but that was because they weren¿t taking one of their medications. It was stated when the patient got back on the medication their walking got better but in the last few weeks or months prior to report the patient¿s walking had gotten worse. It was noted, the patient had a magnetic resonance image (mri) performed on one of their arms a couple of months prior to report. It was further reported, the patient had a surgery the day prior to report to replace their batteries.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3796324
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« Reply #144 on: July 04, 2014, 10:24:11 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2007 (b)(6), explanted: 2013 (b)(6); product type implantable neurostimulator product id 7426, serial# (b)(4), implanted: 2007 (b)(6); product type implantable neurostimulator product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 3387-40, lot# j0214131v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 7438; product type programmer, patient product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0214131v, implanted: 2002 (b)(6); product type lead. (b)(4).
Event Description
It was later reported that the patient was not doing well. The patient was ¿doing the same falling. ¿ patient loses her balance, crosses her feet and her legs freeze causing her to fall. It was noted that this had been going on for ten years prior to the date of this report. The patient would fall 2 or 3 times a day. It was noted that as a result of the falls the patient had had to have knee replacements and knee cap surgery. The patient had a walker but if she had to grab or anything she fell. It was noted that when the first implant was put in 2002 it had helped with her walking. The battery was replaced in 2007 and it ¿did good¿ for about a week and then the patient all of a sudden started having trouble walking. In 2013, one of the batteries was replaced but the other had shown no wear and it was unknown how or why. The device did help with the patient¿s tremors. The patient did not know if she wanted the lead fixed because, she had been in the hospital for 2 weeks and spent 3 months in a nursing home recovering. It was noted that the right battery was the one that was replaced in 2013 and the left was the one that had shown no use, left battery was like brand new. Reference manufacturer¿s report number: 3004209178-2012-10670.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3897360
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« Reply #145 on: July 04, 2014, 10:24:53 PM »

Model Number 37612
Event Date 09/24/2013
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the patient was implanted with a deep brain stimulator on 2013-(b)(6). After the operation, the patient had poor therapeutic effect and had difficulty walking. The patient wanted the device reprogrammed. Additional information indicated that the physician found that the target point of the lead was too deep. A second surgery occurred on 2014-(b)(6) to adjust the position of the lead. Following surgery, the patient¿s symptoms were improved, but after ten days the symptoms returned. Further information indicated that no additional action had been taken since the patient¿s symptoms had returned, and no action was planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899589
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« Reply #146 on: July 05, 2014, 12:33:13 AM »

Model Number 7426
Event Type Injury Patient Outcome Other
Event Description
It was originally reported on (b)(6) 2014 that the patient¿s knees had been ¿collapsing on him for about a week,¿ but the main issue was that he had trouble getting back up. The patient had trouble walking, but the reporter noted, he always had trouble with balance. The reporter wanted to check the patient¿s implants to make sure they were working. Both sides showed ¿on and okay. ¿ about a month later, it was reported that the cause of the event was cognitive issues and disease progression. An infection workup was negative. The patient had hallucinations and was delusional. The patient was wandering in his home and had a few falls due to knees buckling. This was not a new issue and the patient was started on quetiapine. No hospitalization was required and the patient outcome was marked as no injury.
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2010 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0527242v, implanted: 2005 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2005 (b)(6); product type extension product id 3389-40, lot# j0527242v, implanted: 2005 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2005 (b)(6); product type extension product id neu_unknown_prog, serial# unknown; product type programmer, physician. (b)(4).

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« Reply #147 on: August 11, 2014, 01:17:30 AM »

Model Number 37601
Event Type Injury Patient Outcome Hospitalization
Event Description
It was reported that there was a loss of efficacy which was unrelated to stimulation therapy. Patient¿s current battery voltage was 2. 66v. In the past few months prior to the date of this report, the patient had been having issues with freezing and gate issues. A longevity calculation was performed to estimate the battery life of the implantable neurostimulator (ins). Based on the current settings the ins would last 9. 5 months and the patient was implanted 18 months prior to the date of this report. There was 100% usage. There were no known falls or traumas. The patient used a walker and may have fallen and not reported. The ins had seemed to be moving further down. It was unknown if it was loose in the pocket as it was sutured to fascia. The patient was in the hospital for the past few days prior to the date of this report which involved some anxiety along with other possible deep brain stimulator related issues, stiffness and ankle swelling. Patient had contacted the healthcare professional in (b)(6) to be seen, patient was seen on (b)(6) 2014. Healthcare professional had requested patient come back in for more diagnostic testing before replacing the ins. Patient had control but could not tolerate the increased amplitude. The patient was trying to increase to alleviate the freezing and gate issues. Patient¿s current settings were 5. 1v amplitude, rate was 170hz, pulse width was 90 and impedance was 1630 ohms. It was later reported patient had recently had some medical symptoms which were concerning but which may not be related to the deep brain stimulator therapy. Extensive impedances were run and all impedances were normal. Program 1 was at 5. 0v, 90pw, 170hz, and 1033 ohms. Program 2 was at 5. 1v, 90pw, 170hz, and 1611 ohms. It was noted that at those parameters, the ins would last about 19. 19 months. The ins seemed to be at the appropriate charge level based on the information. There was no longevity complaint. Patient was having an mri and it was part of the medical work up and they did not suspect deep brain stimulator failure/malfunction considering the longevity estimate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3950089
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« Reply #148 on: August 11, 2014, 07:53:59 AM »

Model Number 7426
Event Date 06/04/2014
Event Type Injury Patient Outcome Other
Manufacturer Narrative
Concomitant medical products: product id 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator; product id 3387-40, lot# j0406144v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 7438, serial# (b)(4), product type: programmer, patient; product id 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension; product id 3389-40, lot# j0225447v, implanted: (b)(6) 2002, product type: lead. (b)(4).

Event Description
It was reported that the patient had seizure like symptoms when the manufacturer representative left on the day of the report. The reporter noted that the patient had an implant replaced due to battery depletion and he may have been overstimulated at the time of the report. Additional information was requested, but was not available as of the date of this report. Refer to manufacturing report #300420917 8-2014-12534 as the patient had dual implants and it was not specified which ins was the issue.

Event Description
Additional information received reported that the patient was seen on (b)(6)-2014 for normal programming. The battery was tested and within normal limits of voltage, the leads were found to be fine, and the device was working as expected. The patient did present with gait issue, facial pulling, and finger tapping; all of which were much improved with reprogramming. There was no mention in the patient¿s file of any seizure or seizure like activity reported by the patient or anyone else. As far as the doctor¿s office was concerned the patient was experiencing therapeutic effect and the system was working as designed and intended.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913995
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« Reply #149 on: September 06, 2014, 12:59:00 AM »

Model Number 7428
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that a patient being treated for parkinson¿s disease went to the hospital for programming in (b)(6) 2014 and that at that time the patient¿s physician found their battery had depleted. The battery depletion was reported to have been ¿normal battery depletion. ¿ the patient was reported to have experienced right hand rigidity and trembling, difficulty walking, and pain at the implant site and to have experienced these symptoms following the replacement surgery. Additional information has been requested, but was unavailable at the time of this report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013492
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« Reply #150 on: September 06, 2014, 02:02:43 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Event Description
It was reported that the patient had had balance issues and trouble with speech since implant. It was noted that the patient had fallen a couple of times. Initially it was thought that the patient¿s medication was off but he had been off the medication and was still having problems. Patient had been instructed to turn stimulation down and had further programming appointment scheduled for the friday following the date of this report. Patient¿s stimulation was down from 3. 30 and 4. 10 to 3. 0 and 3. 40. Patient¿s status was unknown. It was later reported that there was disappointment and dissatisfaction expressed about the therapy as far as what had been sold and presented to them prior to implant and what had happened in reality. Patient had tremors prior to the deep brain stimulator implant. Patient had been pretested and it had worked for him. Almost 2 months after implant the patient had a lot of issues. Patient¿s quality of life had not increased. Patient had an appointment scheduled for (b)(6) 2014. Patient was experiencing symptoms. It was noted that the patient had expected it to be an outpatient surgery and instead patient had spent 10 days in rehab. The patient had been told about the risk of infection and stroke but nothing else. The patient had been trained on using the patient programmer but did not know what to do with it. The patient was not very discouraged and not positive. The patient was not enjoying things in life anymore. It was noted that prior to deep brain stimulator surgery the patient had only had some tremors and had not been that advanced with parkinson¿s disease symptoms. The deep brain stimulator surgery was supposed to make the patient better but had made him worse. Patient was not able to return to his physical job. Patient¿s symptoms were change in gait, lethargy, and seizures. It was further noted that the manufacturing representative had been there when the patient had a seizure and the representative had come to rehab. The patient had had a seizure right after surgery at the hospital on the date of implant. At rehab the patient had been completely out of it and had been unresponsive. The healthcare professionals were blaming it on medications. Patient was put on 4 different seizure medications, one being dilantin. Patient no longer took seizure medication. Patient was unresponsive and was sent for a computerized tomography scan (cat scan) which had determined the patient had seizures and that was when patient was put on seizure medications. The healthcare professionals had stated ¿oh no, he should be responsive. ¿ it was noted that nobody seemed to know what was going on. They had come for physical therapy and were not able to wake him up, he had been completely out of it. An electroencephalogram (eeg) was done and had not found anything particular. Following deep brain stimulator surgery patient had the following symptoms: speech issues, gait issues, balance problems, patient had fallen several times, extremely tired, swallowing issues, patient looked at food as if he did not know how to put a fork into it, and patient looked like he had aged (b)(6). Patient used to work full time, go to ymca 3 times a week and drove a car, patient was no longer able to drive or do anything. It was hard to leave the patient alone. It was believed that symptoms were device related because patient had no chemicals in his body except some medication for parkinson¿s and it was not a lot. Healthcare professionals stated they had never seen those symptoms after a deep brain stimulator surgery. Patient was told that this kind of reaction was very common and it might take 6 months to a year to recover from the surgery. Patient had been given a limit on the patient programmer and could not go beyond ¿4 or something. ¿ patient had been adjusting therapy all the time on his own. Patient got better here and there but still had a lot of issues going on and was no longer positive. Patient was scheduled to see the healthcare professional on friday following the date of this report. Additional information received reported the patient was having some gait and speech issues related to programming. Patient had primary tremor with parkinson¿s and as the patient would get tremor control he would get some speech issues. The patient had since been reprogrammed to a bipolar setting and although he had a little bit of a breakthrough tremor his balance was better and so was his speech the last time the manufacturing representative had spoken to the patient. It was unknown if there were any other updates. The manufacturing representative had been involved with the patient through rehab. It was noted that the patient¿s family was anxious about getting the patient¿s progress and getting him programmed so he could go back to work. As of the week prior to the date of this report the patient was doing better and was planning on returning to work. Additional information received reported the alleged seizure was not the reason for rehab and all of their patient¿s go through a rehab cycle. Seizure was not confirmed and had been discussed after the fact. The patient was having some cognitive issues after the battery placement that had led the healthcare professional to believe it may have been a seizure. Patient had been placed on seizure medication and had not had any seizure activity after the first alleged one. Additional information was requested but had not been received as of the date of this report.
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jcu8, implanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979081
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« Reply #151 on: September 06, 2014, 02:23:38 AM »

Model Number 7428
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that a patient being treated for parkinson¿s disease went to the hospital for programming in (b)(6) 2014 and that at that time the patient¿s physician found their battery had depleted. The battery depletion was reported to have been ¿normal battery depletion. ¿ the patient was reported to have experienced right hand rigidity and trembling, difficulty walking, and pain at the implant site and to have experienced these symptoms following the replacement surgery. Additional information has been requested, but was unavailable at the time of this report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013492
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« Reply #152 on: September 06, 2014, 05:14:49 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. 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. Product id: 3387s-40, lot# va0arp9, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0bbqp, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).
Event Description
It was reported that the patient¿s hands had started to clasp together during the night since (b)(6) 2013. After that, three months after implant, the patient began falling a lot. The patient fell once or twice a day and in (b)(6) 2014 he broke his leg. The patient had not fallen since that time. The patient had lost a lot of coordination and stumbled when he walked. The patient would hold on to something when he walked to keep himself more stable. This issue had been happening for ¿a while,¿ but the patient could not provide an exact date, and he thought his coordination could be getting worse. The healthcare provider (hcp) thought the cause of the event was gait ataxia or possible orthostatic hypotension with polyneuropathy. The therapy was still working for the patient¿s tremors. The patient had an appointment scheduled with his implant surgeon for (b)(6) 2014. Medical intervention and the patient outcome were not reported, so additional information was requested. If additional information is received, a supplemental report will be sent. Refer to manufacturing report #3004209178-2014-15622 as the patient had two ins¿s and it was not specified which was the issue.

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« Reply #153 on: October 12, 2014, 02:45:58 AM »

Model Number 37601
Event Date 08/06/2014
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient had ¿not been able to have effective stimulation since the implant¿ and that ¿she was worse off with her symptoms¿ following the replacement of her previously depleted implantable neurostimulator (ins). The patient had met with her physician and was told ¿it was the implanted battery that was not working¿ and that ¿they were not able to adjust stimulation. ¿ despite this, it was noted the physician had ¿cranked the stimulation up from 3. 9 to 4. 8 (volts)¿ with ¿no change¿ in the patient¿s symptoms. The patient was ¿unable to get up on her own, she was constantly freezing due to the condition, her head was falling to the side and freezes until she is assisted¿ and she had ¿lost weight¿ and had ¿no appetite¿ at the time of report. The patient ¿could not walk by herself¿ either at that time. It was reported the patient experienced ¿lethargy, loss of reflexes, paralysis, and less than 50% therapy relief¿ that was associated with the event. Information regarding interventions and the patient¿s outcome was not available. Additional information has been requested. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4118705
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« Reply #154 on: October 13, 2014, 12:49:16 AM »

Model Number 37603
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387s-40, lot# va01d5k, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708640, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va01ngu, implanted: (b)(6) 2012, product type lead; product id 37085-40, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

Event Description
It was reported the patient had fallen and broke their shoulder on (b)(6) 2014 and had surgery the following day. They had therapy for about 3 weeks and things were progressing. They thought their symptoms after surgery were worse than before but the last 2 or 3 days prior to report their symptoms had gotten much worse. They had worked with a physical therapist at home on the day of report and could barely walk across the room. They had more shaking getting started from a dead stop. There was a patient injury and a loss of therapeutic effect. It was noted the patient programmer batteries were dead and they had never used the programmer in two years. The patient changed the batteries and performed a check on the right side first. They saw a doctor and phone screen. After, they performed a check on the left side and they saw ¿on and ok¿ for the left side. The patient outcome was not provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4080014
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« Reply #155 on: October 13, 2014, 01:55:35 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078072
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« Reply #156 on: October 13, 2014, 03:47:20 AM »

Model Number 37602
Event Date 08/06/2014
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient¿s implantable neurostimulator (ins) was changed the day prior to report and ¿the nurse who was doing the settings put the patient¿s settings too low. ¿ the patient was ¿complaining of having breathing difficulties, freezing, head fallen sideways, trouble walking,¿ and stiffness of her neck at the time of report. The patient had also reportedly ¿fallen from bed because of the freezing in her body. ¿ the patient was instructed to go to the emergency room at the time of report due to her ¿loss of therapeutic effect¿ following the ins replacement. Upon replacing the patient¿s devices, the patient had reported ¿feeling a little bit of tingling in her finger at a higher setting¿ so the nurse had lowered the patient¿s settings. Later however, when the patient recovered from anesthesia, ¿all of the parkinson¿s symptoms returned with a vengeance¿ on the morning of the report. Additional information has been requested. A supplemental report will be filed if additional information is received. Please see manufacturer report #3004209178-2014-16425 for information regarding the patient¿s other ins.

Manufacturer Narrative
Concomitant products: product id 37602, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4062858
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« Reply #157 on: November 07, 2014, 10:59:42 PM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient was seen last in (b)(6) 2013 and they would be seen by their clinician 2 days following report. The electrode impedances were measured and they were all fine and normal. The ins that was implanted on their right chest had a slight tingling sensation to their arm. Additional information received reported the patient still had concerns with their device or therapy, but they were working with their manufacturer representative or doctor. It was stated they had an appointment scheduled for (b)(6) 2014. Additional information received reported there was a 50% or greater symptom reduction. It was later reported that the patient was scheduled to have both of the implantable neurostimulators (inss) replaced on (b)(6) 2014. The patient was seen on (b)(6) 2014 for adjustment and reprogramming. The right stimulator was interrogated and the patient had mild paresthesia in the left arm. Right side settings were at 4. 1v, 90usec, 185hz, and 3+2- with minimal tremor in the left arm. The patient was seen on (b)(6) 2014 and there was no evidence of discontinuity of the leads of extensions. The patient¿s was also seen on (b)(6) 2014 for a device adjustment, weakness and gait difficulty. The weakness onset had been gradual and occurring in a persistent pattern for 4 months prior to the appointment, but had first occurred more than 40 years of age. Weakness had been characterized as difficulty arising from a chair, climbing stairs, walking, and increased weakness following exertion and at the end of the day. Weakness was located in the legs and on the right side only. It was associated with numbness. Patient had falls, difficulty ambulating and a gait disturbance. Onset for gait issues had been gradual starting about 8 months prior to the appointment, but was worsening. The patient had slow speech, romberg sign positive, impaired toes, and was tandem walking impaired which were noted during a physical exam. The patient was still experiencing frequent shocks with the battery with fluctuating responses of the battery. The patient was going to be scheduled for a neurosurgery appointment for a battery change. For numbness and tingling, low back pain and right leg weakness an electromyography (emg) and computerized tomography (ct) were going to be performed. Reference manufacturer¿s report number: 3004209178-2014-12463 for the patient¿s other implanted system and the shocking issues that were isolated to that system.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v368056, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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« Reply #158 on: November 08, 2014, 03:42:46 AM »

Model Number 37751
Event Date 09/22/2014
Event Type Other
Event Description
I had a metronic neurostimulator implanted in (b)(6) 2014 then my legs became weak, joints feel like i have arthritis, had chronic low grade temp, burning at battery and pain every where leads, battery and paddle implanted, had so much weakness in my legs that i was having trouble walking and had to have it removed at another facility in (b)(6) 2014 and still having arthritic symptoms and back pain.

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« Reply #159 on: November 08, 2014, 04:30:15 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389-40, lot# j0357358v, implanted: (b)(6) 2004, product type: lead. Product id: 3389-40, lot# j0340483v, implanted: (b)(6) 2004, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. (b)(4).

Event Description
It was reported that one time the device turned off within the last 2 years prior to the date of this report and the patient was sent to the hospital due to the fact the he got to the point where he could not move, walk or talk, was diaphoretic and his blood pressure went up. This had not been within the last year prior to the date of this report, so it had happened prior to the last year. No interventions or outcome were reported. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4156403
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« Reply #160 on: December 06, 2014, 12:26:14 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # va0a55s, implanted: (b)(6) 2013, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension. (b)(4).

Event Description
It was reported that after implant of the implantable neurostimulator (ins) the patient had ambulation problems. The patient thought it was a normal progression and not caused by the surgery. The patient had the implant surgeries done very close together. For the surgery, the patient was put to sleep and when they woke up they could not walk. Prior to implant the patient was able to walk. The patient was walking on their toes, freezing, and they were living in assisted living to see if their balance would come back. The patient had been feeling better than they had for years. Since implant the patient had been doing great with hardly any tremor and they had been able to reduce some of their medications. The patient had been doing physical therapy and their healthcare professional stated they could not go home because of their balance and the risk of falling down. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4242507
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« Reply #161 on: January 10, 2015, 02:48:08 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7436, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v281324, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v268107, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 7436, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient¿s therapy wasn¿t as good as it used to be. The patient noticed this change a couple of years ago. The patient had a hard time walking and his hands shake more. His head was shaking but not as bad as it was prior to implant. The patient had set up appointments in the past, but never went to them. The patient had a follow up appointment on (b)(6) 2013. There was also a problem with the patient programmer. It had last worked a week prior. It was later reported when the patient had first had the device put in they had had a problem with the top of their head. The patient could feel electricity when they put it on but that had gone away. The patient had tremor. The patient had felt great after the first operation but now had not, the patient still could not write and had been shaking ever since she was young. It was unknown when the implantable neurostimulator (ins) had become less effective. It was noted that when the patient was in the army it was not bad and the patient sort of hid the shaking. The patient was a wreck. The patient had not felt quite as great as he should for quite a while. The patient¿s device was replaced on the day prior to the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340112
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« Reply #162 on: January 10, 2015, 04:29:07 AM »

Model Number 7428
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported the patient was hospitalized on (b)(6) 2014 for walking difficulty. By (b)(6) 2014, the patient¿s symptoms of walking difficulty and leg weakness had not improved after taking medicine every day. The patient suspected the implantable neurostimulator (ins) was turned off accidently before they took their medicine. On (b)(6) 2014, the patient was reprogrammed and the ins was not turned off. The patient¿s healthcare professional did increase the voltage by 0. 1v and their symptoms got much better. The cause of event was not determined and the patient was doing well at the time of this report.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4331580
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« Reply #163 on: January 10, 2015, 04:29:50 AM »

Model Number 37612
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported the patient was experiencing sudden symptoms of feeling terrible, swaying, being off and losing balance, staggering, and not being able to walk. The patient was not feeling well and they were experiencing balance problems around 2014-(b)(6). The patient had gone to the hospital and they were feeling much better on thursday of last week after they were sent a replacement antenna. On the day of this report the patient¿s symptoms returned and they were re-admitted to the hospital. The healthcare professional (hcp) wanted to know if there was another problem with the antenna. The hcp believed that both implantable neurostimulators (ins) were on, but one was losing charge fast and the other was also losing charge. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent. Refer to manufacturer report #3004209178-2014-23956.

Manufacturer Narrative
Concomitant: product id 37612, serial# (b)(4), implanted: 2012-(b)(6), product type implantable neurostimulator. Product id 7482a51, serial# (b)(4), implanted: 2011-(b)(6), product type extension. Product id 3387s-40, lot# v194784, implanted: 2011-(b)(6), product type lead. Product id 37651, serial# (b)(4), product type recharger. Product id 37642, serial# (b)(4), product type programmer, patient. Product id 3387s-40, lot# v154598, implanted: 2009-(b)(6), product type lead, product id 7482a51, serial# (b)(4), implanted: 2009-(b)(6), product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330538
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« Reply #164 on: January 10, 2015, 11:50:38 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that two days prior to the date of this report the patient had been defibrillated and since then the patient¿s parkinson¿s disease had been declining. Following the defibrillation when the patient had returned to the nursing unit the patient¿s conversation had not made sense and he was disoriented to place and time. The patient¿s muscle tone was there but when he had stood up it required two people to help him walk and his gait was shuffling. The patient tried to drink with his finger and had hallucination. The patient was getting worse on the date of this report. It was noted that the patient¿s wife knew how to operate the patient programmer but the programmer was not with them at the time of this report. The healthcare professional thought the stimulation was on because you could see the artifact on the electrocardiogram (ekg). They were afraid to use the patient programmer to read the device status after the defibrillation. The patient¿s wife was instructed on using the programmer to the check the device status and it read on and ok so there was nothing wrong with the deep brain stimulator device. The patient¿s medical issues were not related to the deep brain stimulator.

Manufacturer Narrative
Product id 3389s-40, lot# v902684, implanted: 2012 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4293886
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« Reply #165 on: February 07, 2015, 07:28:52 AM »

Model Number 37602
Event Date 12/08/2014
Event Type Injury
Event Description
It was reported that the gait was worse secondary to left implantable neurostimulator (ins) deep brain stimulator (dbs). The patient had right sided paresthesia secondary to left ins dbs. The patient reported that when the left ins was on side effects of right sided paresthesia described as surging/tingling present. The patient reported that the left dbs settings made the gait worse. The patient reported that he walked best when the left dbs was off and the right dbs was on. Actions taken due to the event included reprogramming. The patient reported the display showing ¿call your doctor¿ icon. The elective replacement indicator (eri) indicator was showing up on the left ins despite the battery potential being at 2. 73 on (b)(6) 2014 and 2. 77 on (b)(6) 2015. The patient reported on (b)(6) 2014 that he was checking the left dbs battery with his patient controller and it read ¿eri. ¿ the patient last had his battery changed on (b)(6) 2013. The patient continued to turn dbs off at night and use it primarily while eating and when needing to use his right hand. The patient was not able to adjust stimulation. At one point the patient¿s amplitude was decreased to 0. 6 volts. Impedances were within normal limits. The patient believed that the battery should have lasted longer. Longevity calculations were performed and it appeared to be normal eri. The current battery level was 2. 7 although the trip point for eri is 2. 6 volts. It appeared to be premature eri message. The patient had an unscheduled clinic or office visit. The event was reported as ongoing. The patient was not tolerating the dbs therapy, however they were currently attempting to rule out dbs therapy and it may not be related. The patient reported these symptoms previously. The patient¿s settings were decreased due to the patient¿s walking being affected while the stimulator was on. The patient was not able to keep the left ins on most of the time due to side effects of paraplegia and gait problems. The patient¿s setting were decreased 1 volt but when the stimulation was turned on the patient was having mild paraplegia, voice change, but the tremor was better than before the ins was lowered.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v006354, implanted: (b)(6) 2006, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 748240, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3387s-40, lot # v006354, implanted: (b)(6) 2006, product type lead; product id 748240, 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=4470622
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« Reply #166 on: February 07, 2015, 07:29:58 AM »

Model Number 37601
Event Date 01/05/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id; 64002, lot# n324251, implanted: (b)(6) 2012, product type: adapter. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# j0537471v, implanted: (b)(6) 2005, product type: lead. Product id: 3387-40, lot# j0542964v, implanted: (b)(6) 2005, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension. (b)(4).

Event Description
It was the patient had trouble waking and was admitted to the hospital on (b)(6) 2015. The patient was not able to walk or get up and their parkinson¿s symptoms were getting worse. The manufacturing representative met with the patient the day prior to this report and found the implantable neurostimulator (ins) was at end of service (eos). The ins battery depletion was normal. The ins was replaced the same day. The patient was frail and the ins looked like it was going to come out of their chest. The healthcare professional (hcp) was concerned another ins would erode through the skin. The hcp decided to remove the ins and pocket adaptors and implant two inss. One of the new ins's was implanted on the patient other side. Before the two new ins's were implanted the hcp noticed the old ins had caused erosion in the skin and there was a hole where the edge of the ins had been sitting. The hcp had to cut some of the skin and sew it back up. The hcp felt the ins was too large and the edges were too sharp. The patient was started on intravenous antibiotics and the patient stayed the night in the hospital. The cause of the erosion was not determined. The inss were turned on after implant and the patient had been receiving effective therapy in the recovery room. All impedances were measured to be normal.

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« Reply #167 on: February 07, 2015, 07:31:24 AM »

Model Number 37601
Event Date 12/18/2014
Event Type Malfunction
Event Description
It was reported the patient saw their healthcare professional (hcp) for an adjustment the day prior to this report and they could hardly walk after. The patient stated the hcp was trying to adjust them, but they made them worse and they were walking like they were drunk. The hcp adjusted the patient back to the original settings, but the patient was still messed up. The patient wanted to lower both sides, but they could not. Every time the patient¿s setting went up they felt pins and needles running down their legs. The pins and needles had been going on since implant a month or so prior to this report. The patient¿s left side was at 1. 50v and the right side was 1. 50v. The patient stated one of them went down to 1. 10v, but then it popped back up and they could not lower it. The patient wanted to lower the settings on both sides so the feeling would go away. A lower limit screen was reached when the patient tried to lower the left side. The patient thought they were able to lower the left side before. The patient was able to lower the right side to 1. 10v. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 7 482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3387s-40, lot# v281324, implanted: (b)(6) 2009, product type: lead; product id 3387s-40, lot# v268107, implanted: (b)(6) 2009, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 64002, lot# n450589, implanted: (b)(6) 2014, product type: adapter. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4399221
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« Reply #168 on: February 07, 2015, 12:10:49 PM »

Model Number 37601
Event Type Malfunction
Event Description
It was reported that the patient had the device implanted on (b)(6) 2014 for parkinson¿s and the patient believed the right side was disconnected. The patient had a return of tremors on the left side, he could not walk and kept falling. It was noted that when the patient was taking a shower he had rubbed his head kind of hard and scratched it a little and when he pressed down on his head he could feel tingling in his feet and legs on the left side. This had all begun 3-4 days prior to the date of this report. The patient had called and scheduled an appointment for (b)(6) 2014. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0d7cw, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4). (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4388049
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« Reply #169 on: February 07, 2015, 12:11:37 PM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient was experiencing paresthesia and difficulty walking. The symptoms had occurred following implant. The patient had had problems with her arms since the device was implanted in (b)(6) 2012. Both arms had problems, arms were swollen at night time and some nights it was more than others. The patient kept twisting and turning at night because of her arms. After discussing with her healthcare professional the patient was told she was fine. The healthcare professional was seen a long time ago and had not been seen since. The patient had had a problem with their device since surgery and had gone through a 2nd surgery on one side, they had to open up the patient¿s head and do a wiring thing. The patient¿s wires were crooked and the patient had had surgery but they were still the same, the patient had not seen any change. The patient was unsure what was wrong with it because, they were having problems with their head but now was having trouble with their neck. Every time the patient saw their healthcare professional they got numb on one side which had never happened before, they had had it before but it had gone away. The patient had had it in both legs prior to surgery. After her legs were fine and her arms, but she could not sleep at night. The patient had a funny feeling in her arms. The healthcare professional told the patient that it had nothing to do with surgery. It was noted that it might be an iron deficiency, but the patient wondered why their legs were not affected since they believed an iron deficiency would not impact just their arms. The patient¿s walking was very bad, she fell on her face when she walked and one time she fell and broke her hand but was told by her healthcare professional that this was not from parkinson¿s. The patient had an appointment scheduled for (b)(6) 2014. The patient had had a computerized tomography (ct) scan and found out there was a problem with the wiring in the brain that they had never told her about. The ct had been taken at the second surgery in (b)(6) 2012. The patient also had an appointment scheduled for (b)(6). 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.

Manufacturer Narrative
Product id 37603, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3387-40, lot# va00fze, implanted: 2012 (b)(6); product type lead product id 3387s-40, lot# va005vq, implanted: 2012 (b)(6); product type lead product id 3387-40, lot# va00fze, implanted: 2012 (b)(6); product type lead product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37603, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# va005vq, implanted: 2012 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4384352
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« Reply #170 on: February 07, 2015, 12:12:12 PM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

Event Description
It was reported the patient was having a lead revision next year due to gait freezing. The patient had a lead in the subthalamic nucleus for parkinson¿s disease and the revision is for a lead to be placed in the ¿stn and snr. ¿ the patient¿s healthcare professional (hcp) did not want to remove the entire system for an mri so the hcp was going to plan the revision from the patient¿s old mri and just replace the lead. The manufacturing representative was not aware of anything wrong with the lead. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4380328
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« Reply #171 on: March 07, 2015, 05:01:59 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va0mlnr, implanted: (b)(6) 2014, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va0mqlu, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported that after implant the patient had the flu, a bladder infection, and then trouble breathing. The deep brain stimulation was not helping as the patient expected and they never had therapeutic effect. The patient stated they were in worse shape now than before the surgery. The patient had concerns with freezing and trouble walking. About two weeks prior to this report they went down to their knees due to trouble walking. The patient stated that they saw somewhere that deep brain stimulation was not for freezing or walking. Since implant the patient had developed bladder control issues at night. The patient has macular degeneration and since implant their eye healthcare professional (hcp) told them they had developed ¿a jelly type thing behind their eye that was putting pressure on their eyes. ¿ the eye hcp was not sure if it was related to deep brain stimulation or not. After the stage one and two implants the patient had a stent in the left leg implanted and a vein closed in their right leg. Reprogramming had been done twice and the patient¿s last appointment with their hcp was on (b)(6) 2015. The patient¿s next appointment was scheduled for (b)(6) 2015. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4480167
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« Reply #172 on: March 07, 2015, 05:02:33 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had waist/hip pain in (b)(6) 2015. The patient went to the hospital for treatment, but the reason for the pain was unknown. The patient¿s family suspected the implantable neurostimulator (ins) was depleted and that caused the patient to not be able to stand and walk. The patient was hospitalized at the time of this report. The reporter wanted the patient¿s ins to be checked by a manufacturing representative. Follow up indicated that it was unknown if the ins had depleted and the patient still had waist/hip pain and they could not stand or walk. No interventions or outcome were reported regarding this event. Additional information could not be obtained. Should additional information be received the event will be updated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4520956
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« Reply #173 on: March 07, 2015, 05:03:15 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had the following symptoms: altered mental status, burning sensation, change in gait, difficulty walking, leg dragging and swelling. The patient¿s stimulation had to be turned up pretty high in order to control his tremor. Sometimes when it was so high he had a burning sensation in his face. When stimulation was turned off he still felt the burning sensation and he wanted to know if this was normal and if it was possible that it could cause permanent damage. When stimulation was turned off it took a couple of days for the burning to stop. The burning in the patient¿s face had started sometime in early to mid-(b)(6) 2014. There was a spot right about his lip that took longer to have the burning go away and sometimes it would take about a month before the burning stopped. The patient had two leads, one on the right and one on the left that were both connected to an one implantable neurostimulator (ins) which was in his left chest. The patient was told that in order to help with the progressive tremor and the burning in his face they would need to implant a 3rd lead and another ins in the other side chest and the patient was inquiring if this was normal. The patient¿s tremor was progressing and he was able to tell weekly because the tremor was moving and increasing. The patient¿s left hand was getting worse and he gait was also changing. Sometimes the patient had voice trouble, with tremor in his voice and sporadically he had uncontrollable tremor with his head and eye lids. The stimulation had worked at controlling his symptoms for a few months but the tremor had been gradually increasing so the patient was unsure if it was a stimulation issue or a symptom issue. Amplitude was set at 1. 3 volts on the right side of the brain. The patient had a fall a couple of weeks prior to the date of this report, the patient stated that he had many ¿almost falls¿ but the last one was a couple of weeks prior to the date of this report. It was noted that it had been a nightmare since day one. The patient stated that when the leads were put in the brain he had an edema of the brain and they were not sure what the swelling was from but the patient had brain damage from the swelling. After the implant they had brain swelling. The patient had blood clots from being down for so long. Also, the patient was unable to use the right side of his body for a few days after the surgery. The patient zoned out, the nurse would bring the patient into a dark room and he would not be able to figure out what he was supposed to do until he was directed to turn on the light. The patient had stated that it was like he knew what to do but would get stuck in between what he should do and how to do it. On occasion he would have to use the left hand to move the right hand and also he would want to use his right hand but he wouldn¿t know how to use it. The patient was able to walk normal but sometimes his leg would drag. Most of the time it was the left leg that would drag but it would also be the right as well but the left was worse. Following implant of the leads the patient was already having problems before he even got home. It was so bad that his wife brought him to the emergency room. It was noted that while at the emergency room the patient was so thirsty, he got up and walked over to the faucet; he could hear the water gurgling in the pipes but forgot to turn on the water so he was trying to suck the water out of the faucet. The patient would drift in and out of reality. The patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative. The patient had an appointment scheduled but the date was illegible. No outcome or intervention was reported. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, 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: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515835
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« Reply #174 on: April 19, 2015, 09:35:31 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
Finet, p. , delavallee, m. , raftopoulos, c. Idiopathic intracranial hypertension following deep brain stimulation for parkinson's disease. Acta neurochirurgica. 2015. Doi: 10. 1007/s00701-015-2354-3. Summary: idiopathic intracranial hypertension (iih) is a syndrome characterized by an increased intracranial pressure of unknown origin arising mainly in overweight females. The typical symptoms of iih are headaches and papilledema associated with visual disorders, which can often evolve to blindness. We describe the first patient who developed a clinical syndrome related to an iih following a bilateral subthalamic deep brain stimulation (dbs) procedure for parkinson¿s disease with the particularity that the clinical expression of the iih syndrome was atypical because of the presence of intracerebral electrodes. Reported event: one (b)(6) female patient was treated with bilateral deep brain stimulation (dbs) implantation of the subthalamic nucleus (stn) for advanced parkinson¿s disease. It was noted that the patient was overweight with a body mass index (bmi) of 46 kg/m^2. The initial postoperative course was marked by a remarkable improvement of the motor symptoms leading to withdrawal of levodopa. However, the patient progressively developed personality changes with apathy and bulimia accompanied by an important weight gain of 15kg in 2 months (bmi: 52 kg/m^2). Three months after surgery, the patient gradually developed a discreet left hemiparesis, a left hemihypoesthesia, dysarthria, and gait disorder linked to her hemiparesis. She also complained of blurred vision and pulsatile holocranial headache. Neurological examination revealed a pseudomeningocele at the level of the entry point of each dbs electrode. A brain ct scan performed 86 days after implant surgery demonstrated a hypodensity surrounding both intraparenchymal electrodes; there was reportedly hypodensity surrounding the right electrode at the level of the basal ganglia and internal capsule. It was noted that there was a suspected hardware infection. However, the white blood cell count, c-reactive protein level, and the wound examination were normal. In the absence of other infection signs, an mri was performed 87 days after implant surgery, which revealed edema surrounding the intracranial electrodes predominantly around the right electrode without any signs of infection on the diffusion-weighted imaging and t1 with gadolinium sequences. Furthermore, the mri revealed a dilation of the optic nerve sheets and an intrasellar meningocele compatible with an idiopathic intracranial hypertension (iih). The mri showed distension of the optic nerve sheaths, a flattened posterior optic glob, slight protrusion of the optic head, an empty sella turcica and an upward tortuosity of the optic nerve. No sinus thrombosis was observed. A fundoscopy showed a papilledema, and a lumbar puncture (lp) confirmed the presence of a high opening pressure (36 cmh2o). The reporter stated that the patient¿s atypical symptomatology was related to the csf infiltration along the intraparenchymal electrodes and then in the extracellular space in the context of intracranial hypertension. The right electrode trajectory was infiltrated along the entire electrode, whereas the left electrode only had a subcortical edema, with the hyper-t2 signal extended in the right posterior arm of the internal capsule, right cerebral peduncle and right thalamus. These radiological findings explained the patient¿s left hemiparesis, left hemihypoesthesia and dysarthria, which were related to swelling of their neuroanatomical substrates. Two cerebrospinal fluid (csf) taps were performed (csf withdrawal of 28 and 40 cc) with a significant transient amelioration of her symptoms. A diet with a loss of weight (bmi: (b)(6)) resulted in complete regression of the symptoms four months after treatment initiation. The reporter stated that the weight gain provoked by the bilateral stn-dbs appeared to be responsible for the ihh development or perhaps for the worsening of a preexisting paucisymptomatic ihh. A brain ct scan performed 2 months after symptom regression (8 months after dbs implant) showed a complete disappearance of the hypodensities surrounding the electrodes. The source literature did not include any specific device information. Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about patient information and additional information regarding the reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4). (b)(4) intracranial hypertension.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620602
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« Reply #175 on: May 09, 2015, 03:05:42 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0ccdl, implanted: 2013-(b)(6), product type: lead. Product id: 3708660, serial# (b)(4), implanted: 2013-(b)(6), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported the patient was having an mri for numbness in their extremities, gait imbalance, and to assess for mini stroke. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4690231
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« Reply #176 on: May 09, 2015, 03:06:26 AM »

Model Number 37612
Event Date 03/25/2015
Event Type Injury
Event Description
It was reported that the patient¿s neurologist called the manufacturer representative (rep) and asked which x-rays would provide the best image of the implantable neurostimulator (ins), extensions, and leads. The patient self-admitted to the emergency room (er) the morning of the report; he had pain on the right side of the neck and a return of symptoms, including speech degradation and a change in gait. It was considered a sudden loss of stimulation and therapeutic effect. The ins was checked by the neurologist using a clinician programmer and it appeared to be on without any problems. The patient was hospitalized due to the event and was referred back to the original implanting physician for evaluation. No surgical interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 64002, lot # n248030, implanted: (b)(6) 2010, product type adapter; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4693815
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« Reply #177 on: May 09, 2015, 03:07:07 AM »

Model Number 37602
Event Date 03/17/2015
Event Type Injury
Event Description
It was reported that the patient was scheduled to have an implantable neurostimulator (ins) replacement on (b)(6) 2015, but then fell on (b)(6) 2015 and the reporter believed ¿it had done something to the wire and it was not working now. ¿ the patient could not walk, do anything, or barely maneuver since the fall. The reporter took the patient to the emergency room (er) because she thought the battery ¿had given out, which it had however she was told that it was not dead, it was still working somewhat, had a little juice left but they ended up replacing it. ¿ the reporter stated that the patient ended up having the battery replaced on (b)(6) a week prior to the report. It was unclear if there was a wire issue or what the patient outcome was, so additional information was requested. If additional information is received, a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389-40, lot# j0555401v, implanted: 2005, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4699304
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« Reply #178 on: May 09, 2015, 03:08:05 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v353787, implanted: (b)(6) 2009, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that when the patient¿s settings were high, their side effects and walking seemed to get worse. The patient had a very severe head, vocal, and hand tremor. The patient had always had this issue. The first implant helped with the patient hand, but could not control the head so they were unable to eat or drink. A revision was done to ¿a research area called sta. ¿ that was ineffective so the patient was being referred to the university of florida for another research area and dual lead. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4707739
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« Reply #179 on: June 08, 2015, 06:57:31 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had surgery last (b)(6) and ¿it had not worked since the implant. ¿ it was noted the patient would ¿pick up speed when they would talk. ¿ it was stated since the surgery the patient had fallen down 6-7 times. It was noted the patient had speech impairment and it was hard to understand them. It was later reported that there was a poor communication screen but they were eventually able to conform with both the left and right sides on and ok. Stimulation was turned off and back on. Since implant the patient had been falling down and losing her balance much more than before the implant. The patient¿s balance and falls had gotten worse after implant and the patient was unsure if it was safe to walk and she used a walker. The patient had had a major fall about 2 months after implant,(b)(6) or (b)(6), she had fallen on the carpet while she was hanging clothes. It was noted that the patient went to rehab after the fall. Patient wanted to discuss turning therapy off to see if it would improve her falls/balance. Patient inquired about lead placement and how it effects stimulation. The patient was not sure if the deep brain stimulator was causing her falls but felt that it was either the deep brain stimulator or disease progression. It was later reported that since implant the patient had balance issues. The patient had never had this before implant and had fallen multiple times. The patient was told that it was due to her recent surgery. The patient was still falling and had broken her hand from a fall. Reference manufacturer¿s report number: 3004209178-2015-08800.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3387s-40, lot# va01zjk, implanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4) implanted: (b)(6) 2012, product type: extension. Product id: 3387s-40, lot# va01zjk, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id 37603 lot# serial#(b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4761849
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« Reply #180 on: June 08, 2015, 06:58:24 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient was left in a nursing home, worse off. Prior to the patient getting the deep brain stimulator he could walk and talk but now he was confined to a hospital bed in a nursing home. The patient could barely feed himself. The patient had gone through the surgery wide awake ¿like a trooper. ¿ it had all gone downhill about 2 months after the deep brain stimulator surgery. The patient had good progress after the surgery for a week to a week and a half or two weeks. The patient was walking, talking, and doing exercises but after that the patient had become wheelchair bound and in a nursing home. The patient could not talk , walk or feed himself. The patient¿s system was checked two years prior to the date of this report. Patient¿s status was unknown. Reprogramming had been tried. The patient had been his healthcare professional¿s and still could not walk or talk.

Manufacturer Narrative

Event Description
It was later reported the patient had deep brain stimulator surgery 4 years prior to the date of this report and it had worked great for almost 2 years but then things had gone downhill fast. The patient could not text.

Manufacturer Narrative
Concomitant products: product id: neu_unknown_lead, serial# (b)(4), product type: lead. Product id: 3387s-40, lot# v626366, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762647
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« Reply #181 on: June 08, 2015, 06:59:01 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v187428, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead. (b)(4).

Event Description
It was reported that the device was implanted on (b)(6) 2013 and right after implant the patient lost functionality. The patient was able to walk with help but was not able to use his hands to eat, could not turn over in bed and could not move himself. The patient had physical and occupational therapy and had regained 30-40% of his functionality. The patient took a lot more sinemet orally. The issues had continued until the patient had a revision. Reference manufacturer¿s report number: 3004209178-2015-09174.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4774612
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« Reply #182 on: July 16, 2015, 12:14:36 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient experienced ¿stimulation in the wrong location¿ and a ¿change in gait¿ involving their ¿left side implant. ¿ it was further reported the patient ¿had new-onset gait freezing with stimulation. ¿ a post-operative ct scan was performed and found the patient¿s ¿lead had deviated when it left the insertion cannula (20mm above the target)¿ and that ¿this resulted in the electrodes being positioned in the wrong brain structure (the posterior subthalamic area (psa), not the subthalamic nucleus (stn) as planned). ¿ it was noted the ¿left lead deviated¿ and that ¿both leads were revised as both ended up medial to the initial plan. ¿ it was additionally noted there was a ¿bent lead. ¿ the patient¿s leads were explanted and replaced as a result of the event. The patient was ¿receiving effective therapy with no gait freezing¿ following their bilateral lead revision. Additional information was requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4850234
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« Reply #183 on: July 16, 2015, 12:15:18 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389s, product type: lead. Product id: 37085, product type: extension. Product id: 37651, product type: recharger. Product id: 37642, product type: programmer, patient. (b)(4).

Event Description
The patient was implanted on (b)(6) 2013 due to parkinson. After implantation, the patient felt the effect was not good. The physician reprogrammed the device many times, but the patient was still not satisfied with the effect. It was unknown if there was a 50% or greater symptom reduction. The patient was epileptic two times in the week after the surgery. The urine tube and gastric tube was not pulled out after the surgery. After surgery it was difficult for the patient to walk. Reprogramming results showed the device was normal. The patient was disequilibrium and dysphasia. No troubleshooting has been done and the event cause was not determined. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4824533
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« Reply #184 on: July 16, 2015, 12:16:18 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the last few weeks had been terrible for the patient. She fell several times and had to go to the emergency room (er) to determine if her kneecap was fractured. Her mental state was deteriorating rapidly, as she cried for the better part of a day because of frustration in not being able to walk ten feet without falling down. Her leg strength was completely gone and simply would not support her body. The patient also had significant pain in her neck that never seemed to diminish. Her right side was not functional and she had developed restless leg, which would not allow her to sleep for any length of time. She could barely perform the basic functions to care for herself. Her emotions were running sky high and the reporter¿s fear was that she was in so much agony that she may harm herself in a fit of anger. The patient had minimal trouble walking before implant, but could hardly walk at the time of the report. She was at the two month mark post-surgery and had seen little improvement in her condition. Her overall condition was significantly worse at the time of the report than prior to implant. The only caution presented prior to surgery was that her iq might drop a few points. The reporter felt this was an understatement as the patient was actually acting ¿like an eight year old. ¿ the reporter questioned her overall competency. Adjustments to the device had yielded little improvement. The patient could not go on like this much longer as her health was deteriorating rapidly. Follow-up from the manufacturer representative (rep) reported that there was 50% or greater symptom reduction. The patient had three programming sessions and had a follow-up appointment scheduled with her doctor for (b)(6) 2015. It was unknown how the patient was doing, but the therapy was being delivered. The patient had not had her appointment with her doctor yet, so additional information will be requested at a later date. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant product/(s): product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642,serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841044
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« Reply #185 on: July 16, 2015, 12:17:11 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387-40, lot# 0209047236, implanted: 2015-(b)(6), product type: lead. Product id: 3387-40, lot# 0209313922, implanted: 2015-(b)(6), product type: lead. (b)(4).

Event Description
During stage two, impedance testing was performed once the system was fully connected. Electrode 8 was out of range, high impedances of >40 ,000. The surgeon disconnected the lead/extension and extension/implantable neurostimulator (ins) on the right side, cleaned and dried leads, then reconnected the system. Impedances were re-tested and 8 was still out of range. The surgeon decided not to continue troubleshooting and closed up. It was noted that it was unknown which lead was the right lead, but the issue was only with the right lead. The company representative confirmed that there was no effect on the patient immediately post-op as the system was yet to be programmed. The neurologist was informed and programmed the patient accordingly. The patient was receiving effective therapy the week following implant. It was later reported that the post-op ct showed the leads were implanted on the medial side of the original plan. The patient experienced a new onset of gait freezing with stimulation. The change in gait occurred at the left and right side of implant. The physicians have turned off the stimulation and will revise (leads will be replaced) in (b)(6). Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4828199
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« Reply #186 on: August 08, 2015, 10:12:29 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported ¿it did not always improve the quality of life. ¿ the patient no longer walked since having one installed and now had tremors that he never had before.

Manufacturer Narrative
Concomitant: product id neu_unknown_lead, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4913392
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« Reply #187 on: August 08, 2015, 10:13:07 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead. Product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was originally reported on (b)(6) 2013 the patient was having program issues with their gait and ability to start walking. The reporter stated they wanted to know if there was a deep brain stimulation data base to find possible solutions for their particular issues. Additional information received reported that the implantable neurostimulator (ins) and extensions were explanted due to generator erosion. The patient recovered without sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953266
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« Reply #188 on: September 19, 2015, 03:17:31 AM »

Model Number 7428
Event Date 08/11/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The consumer via a manufacturer representative reported that the patient was implanted on (b)(6) 2013 due to parkinson's disease. On (b)(6) 2015, the patient's limbs felt rigid and it was difficult for them to walk. The patient suspected that the implantable neurostimulator (ins) was shut down. The patient requested a reprogramming on (b)(6) 2015. No troubleshooting was done and the event cause was not determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5043176
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« Reply #189 on: September 19, 2015, 03:18:14 AM »

Model Number 37612
Event Date 07/27/2015
Event Type Malfunction
Event Description
A consumer reported they had a problem where they were not aware their stimulation was off. For four days the patient was trying to walk and they could not. The patient contacted a health care provider (hcp) and they walked the patient through checking the implantable neurostimulator (ins) and they found the ins had been off for four days. The patient's indication for use is parkinson's dual. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v530117, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v530117, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024964
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« Reply #190 on: September 19, 2015, 03:19:00 AM »

Model Number 37601
Event Date 08/02/2015
Event Type Malfunction
Event Description
The consumer via a manufacturer representative reported that an implantable neurostimulator (ins) was implanted in the patient on (b)(6) 2014 due to parkinson¿s disease. On (b)(6) 2015, the patient had difficulty walking and adjusted the parameters with the patient programmer, but had no improvement. The patient¿s family requested a solution for the symptom. No troubleshooting was done to provide insight to the issue and the cause of the event was not determined.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5035261
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