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Author Topic: Deep brain stimulator - Mental Health  (Read 69039 times)
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dennis100
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« on: November 06, 2013, 12:01:16 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 10/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Received info, reporting the pt was admitted to the hospital for worsening of his mania. The pt's deep brain stimulator has been turned completely off. Additional info has been requested and if received, a follow up report will be sent.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907295

« Last Edit: December 25, 2013, 03:03:24 AM by dennis100 » Logged
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« Reply #1 on: November 06, 2013, 12:01:52 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 03, 2014, 01:34:16 AM by dennis100 » Logged
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« Reply #2 on: November 06, 2013, 12:02:31 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 04/29/2010
Event Type  Death   Patient Outcome  Death
Event Description

Literature: williams a, gill s, varma t, et al. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced parkinson's disease (pd surg trial): a randomised, open-label trial. Lancet neurol jun 2010;9(6):581-591. Summary: this article discussed the results of a one-year f/u in an ongoing, randomized, open-label trial involving 13 centers in (b)(6) of 366 patients with parkinson's disease (pd) that was not controlled by medical therapy who were randomly assigned between (b)(6) 2000 and (b)(6) 2006 to immediate surgery (deep brain stimulation) and best medical therapy or best medical therapy alone. The subthalamic nucleus was the target in 174 out of 178 surgery patients, and 176 of the 178 procedures were bilateral. Patients in both groups received medical therapy, which could have included apomorphine, other dopamine agonists, monoamine oxidase type b inhibitors, cathechol-o-methyltransferase inhibitors, amanatadine, or other drugs used for pd. The primary data used was pt self-reported quality of life on the 39-item pd questionaire. Clinical assessments of functioning using the unified parkinson's disease rating scale in both on and off states and cognitive states using the dementia rating scale-ii also were performed. Changes between baseline and one year were compared. Serious and non-serious adverse events were also recorded. Serious adverse events were defined as those events that resulted in a prolonged stay in the hospital, hospital admission, were thought to be life-threatening, or resulted in death. Reportable event: all of the following events were designated "serious adverse events" as defined above: one pt died from hemorrhage during implantation surgery. Two patients experienced surgery-related hemorrhage. One pt had a hemorrhage five months after surgery. The hemorrhage was considered "probably not" treatment related. Sixteen pts developed surgery related infections. Five patients experienced post-operative confusion that was considered dbs-specific. Two patients experienced neck pain that was considered surgery related dbs-specific. Two patients experienced seizures that were considered surgery related, dbs-specific. One pt experienced deteriorating control of pd because the battery was switched off. There was no allegation that the device malfunctioned. One pt experienced psychosis that was considered surgery related, dbs-specific. One pt became unresponsive on the operating table. The authors believed this possibly to be related to levodopa withdrawal. One pt experienced visual neglect from edema that was considered surgery related, dbs-specific. Four patients experienced urinary retention that was considered general surgery related. Two patients experienced pulmonary embolism that was considered general surgery related. One pt experienced an anxiety attack that was considered general surgery related. One pt experienced post-operative hypotension. In one pt, there was difficulty removing the catheter after surgery. One pt experienced pyrexia that was considered general surgery related. Three patients experienced falls that were considered pd related and/or drug related. Two patients experienced constipation that was considered pd related and/or drug related. One pt experienced two episodes of constipation that was considered pd related and/or drug related. Eleven patients experienced worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related. One pt experienced two episodes of worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested. Two patients experienced chest pain that was not categorized as surgery related or pd related or drug related. One pt experienced angina that was not categorized as surgery related or pd related or drug related. Three patients experienced pain that was not categorized as surgery related or pd related or drug related. Three patients experienced neuropsychiatric disturbance (including hallucinations or paranoia) that were considered pd related and/or drug related. One pt attempted suicide that was considered pd related and/or drug related. The pt previously had attempted suicide prior to trial entry. Two patients had unspecified pd drug related adverse events. Two patients experienced chest infections that were not categorized as surgery related or pd related or drug related. One pt collapsed, which was not categorized as surgery related or pd related or drug related. One pt experienced deep vein thrombosis more than 8 months after surgery that was not categorized as surgery related to pd related or drug related. One patient experienced pulmonary embolism more than 8 months after surgery that was not categorized as surgery related, pd related or drug related. One pt experienced a fainting episode that was not categorized as surgery related or pd related or drug related. One pt experienced vertigo that was not categorized as surgery related or pd related or drug related. Five patients experienced urinary problems that were not categorized as surgery related or pd or drug related.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2116650

« Last Edit: February 03, 2014, 01:34:28 AM by dennis100 » Logged
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« Reply #3 on: November 06, 2013, 12:04:10 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 10/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Received info reported, the pt was admitted to the hospital for worsening of his mania. The pt's deep brain stimulator has been turned completely off. Additional info has been requested and if received, a follow up report will be sent.
 
Manufacturer Narrative

(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1901941

« Last Edit: December 25, 2013, 03:14:45 AM by dennis100 » Logged
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« Reply #4 on: November 06, 2013, 12:04:40 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 04/03/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the patient initially had "excellent response" to their deep brain stimulator after placement. In (b)(6) 2006, it was stated the patient had problems with "hallucinations and vivid dreams. " in (b)(6) 2007, testing showed a decline in the patient's cognitive function "consistent with mild dementia. " on (b)(6) 2007, the patient had their electrodes replaced as it was felt that their initial placement may have been suboptimal. It was not clear the revised electrode placement had any beneficial effect. No further follow up is possible regarding this patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276356


« Last Edit: December 25, 2013, 03:15:54 AM by dennis100 » Logged
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« Reply #5 on: November 06, 2013, 12:05:04 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/04/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description

Literature: capgras syndrome after deep brain stimulation placement for parkinson disease: a case report. David m. Brooks, md, mba, mph (university of pennsylvania, philadelphia, pa); andrew g. Reish, md; miriam segal, md; kelli williams, phd. Aapm&r abstract s18; poster 24. Summary: the authors report on a (b)(6) male who underwent bilateral subthalamic bilateral deep brain stimulator placement for medically refractory parkinson disease. The patient had a previous history of depression, hyperlipidemia and advanced medically refractory parkinson disease. Reportable event: four days post implantation, the patient experienced episodic agitation, poor safety awareness, paranoia and was noted to express paranoid delusions. Neuropsychological evaluation revealed capgras syndrome centered around the patient's wife. The patient was transferred to an acute rehabilitation hospital. Medical treatment with risperidone was initiated. The patient was discharged 14 days later (18 days post operatively). Two months later, the agitation and delusions resolved. The source literature did not specify which device models were used.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917509

« Last Edit: December 25, 2013, 03:17:10 AM by dennis100 » Logged
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« Reply #6 on: November 06, 2013, 12:05:28 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 03, 2014, 01:34:43 AM by dennis100 » Logged
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« Reply #7 on: November 06, 2013, 11:42:20 AM »

Device Problem No Known Device Problem
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: deligny c, drapier s, verin m, lajat y, raoul s, damier p. Bilateral subthalamotomy through dbs electrodes: a rescue option for device-related infection. Neurology. 2009;73(15):1243-4. After implant and adjustment of the dbs parameters and a progressive reduction of drug treatment, the patient experienced a clear improvement of symptoms with no residual motor fluctuations. The patient complained only of a mild dysarthria. Forty days after implant, the patient was readmitted with delirium and pyrexia (39 degrees c). Ct scan revealed an abscess around the tip of the right lead requiring hardware removal. Due to the improvement in the patient's symptoms with dbs, the doctor presented and the patient consented to undergo a subthalamotomy. A radiofrequency lesion was performed under local anesthesia through the dbs electrodes. The procedure was successful and the right lead, extension and device were removed two hours later. Despite antibiotherapy, a similar infection developed four months later around the left lead. Following a left subthalamotomy, the remaining system components were explanted. There was a progressive positive outcome. At the three-month examination, the patient complained of only mild, but not disabling intermittent tremor of the right side and persisting dysarthria, which had not worsened. The patient's "off" drug state was similar to that observed one month after dbs implant. Reference mfr report #3007566237-2009-09297.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564560

« Last Edit: February 03, 2014, 01:35:29 AM by dennis100 » Logged
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« Reply #8 on: November 09, 2013, 05:33:59 AM »

Device Problem Explanted
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description

Journal ref: hooper ak, okun ms, foote kd, et al. Clinical cases where lesion therapy was chosen over deep brain stimulation. Stereotact funct neurosurg. 2008;86(3):147-152. In this paper we review the experience of movement disorders ctr from july 2002 to june 2007, and we identify cases in which a multidisciplinary team opted for lesion therapy over dbs. We will review the rationale for lesions and report the clinical course and outcomes in these individual pts. We will also discuss potential indications for lesion therapy. Reportable event: a man with a 29 yr history of et and a previous dbs lead presented for eval of worsening tremor. After 7 yrs, he presented with his speech affected and tremors that resulted in marked disability. He also experienced periodic panic attacks and depression. An mri of the brain revealed a left thalamic dbs lead with suboptimal placement. Surgery was scheduled to replace the lead; 2 weeks after replacement, he had left-side drainage from the head incision with infection. He had excellent tremor control, but the wound would not remain closed. It was then decided to remove the dbs sys and perform a thalamotomy. Mfr of the dbs devices was not stated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069604
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« Reply #9 on: November 09, 2013, 05:34:32 AM »

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

Journal reference: witt k, daniels c, reiff j, et al. Neuropsychological and psychiatric changes after deep brain stimulation for parkinson's disease: a randomized, multicentre study. Lancet neurol. 2008; 7(7): 605-614. Deep brain stimulation (dbs) of the subthalamic nucleus (stn) reduces motor symptoms in patients with parkinson's disease (pd) and improves their quality of life; however, the effect of dbs on cognitive functions and its psychiatric side-effects are still controversial. To assess the neuropsychiatric consequences of dbs in patients with pd we did an ancillary protocol as part of a randomized study that compared dbs with the best medical treatment (bmt). Sixty pts were randomly assigned to receive stn-dbs and 63 patients to have best medical treatment. Reportable event: severe psychiatric adverse events reported in the dbs group included 1 patient suicide. See mfg report 2182208200805672.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159256
« Last Edit: February 03, 2014, 01:35:43 AM by dennis100 » Logged
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« Reply #10 on: November 09, 2013, 05:35:07 AM »

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

Journal reference: york mk, dulay m, macias a, et al. Cognitive declined 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. Twenty three patients who underwent dbs were compared with 28 medically treated patients with pd at baseline and at 6 months for neuropsychological measures. Reportable event: one patient who did not return for their 6 month follow-up due to psychological distress was not included in these analyses. The first patient was a man, diagnosed with pd 7 years earlier, who committed suicide 4 months after his dbs surgery. He did not have a history of psychological distress or suicidal ideation prior to surgery. See mfg report 2182207200805638.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159260
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« Reply #11 on: November 09, 2013, 05:35:36 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: witt k, daniels c, reiff j, et al. Neuropsychological and psychiatric changes after deep brain stimulation for parkinson's disease: a randomized, multicentre study. Lancet neurol. 2008;7(7):605-614. Deep brain stimulation (dbs) of the subthalamic nucleus (stn) reduces motor symptoms in pts with parkinson's disease (pd) and improves their quality of life; however, the effect of dbs on cognitive functions and its psychiatric side-effects are still controversial. To assess the neuropsychiatric consequences of dbs in pts with pd we did an ancillary protocol as part of a randomized study that compared dbs with the best medical treatment (bmt). Pts were randomly assigned to receive stn-dbs, and pts to have best medical treatment. Reportable event: severe psychiatric adverse events reported in the dbs group included psychosis in some pts. See mfg report 2182208200805672.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159146
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« Reply #12 on: November 09, 2013, 05:36:19 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
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 #13 on: November 09, 2013, 05:36:50 AM »

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

 
Event Description

Journal reference: witt k, daniels c, reiff j, et al. Neuropsychological and psychiatric changes after deep brain stimulation for parkinson's disease: a randomized, multicentre study. Lancet neurol. 2008;7(7):605-614. Deep brain stimulation (dbs) of the subthalamic nucleus (stn) reduces motor symptoms in pts with parkinson's disease (pd) and improves their quality of life; however, the effect of dbs on cognitive functions and its psychiatric side-effects are still controversial. To assess the neuropsychiatric consequences of dbs in pts with pd we did an ancillary protocol as part of a randomized study that compared dbs with the best medical treatment (bmt). A total pts were randomly assigned to receive stn-dbs and pts to have best medical treatment. Reportable event: severe psychiatric adverse events reported in the dbs group included 1 pt with severe loss of affect (apathy). See mfg report 2182208200805672.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159143
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« Reply #14 on: November 09, 2013, 05:37:25 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: witt k, daniels c, reiff j, et al. Neuropsychological and psychiatric changes after deep brain stimulation for parkinson's disease: a randomized, multicentre study. Lancet neurol. 2008;7(7):605-614. Deep brain stimulation (dbs) of the subthalamic nucleus (stn) reduces motor symptoms in pts with parkinson's disease (pd) and improves their quality of life; however, the effect of dbs on cognitive functions and its psychiatric side-effects are still controversial. To assess the neuropsychiatric consequences of dbs in pts with pd we did an ancillary protocol as part of a randomized study that compared dbs with the best medical treatment (bmt). Pts were randomly assigned to receive stn-dbs, and pts to have best medical treatment. Reportable event: severe psychiatric adverse events reported in the dbs group included depression in 4 pts, which remitted by the 6 month follow-up. See mfg report 2182208200805672.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159145
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« Reply #15 on: November 09, 2013, 05:38:06 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: hariz mi, krack p, alesch f, et al. Multicentre study of thalamic stimulation for parkinsonian tremor: a 6 year follow-up. J neurol neurosurg psychiatry. 2008;79(6):694-699. To evaluate the results of ventral intermediate (vim) thalamic deep brain stimulation (dbs) in pts with tremor predominant parkinson's disease (pd) at 6 yrs post surgery. This was a prolonged follow-up study of 38 pts from eight centres who participated in a multicentre study, the 1 yr results of which have been published previously. This long term study was designed to evaluate the additional effect of thalamic dbs on tremor in pts taking their regular antiparkinsonian medication. Reportable event: adverse events reported by the treating centres as being related to stimulation included one case of dementia. See mfg report 2182207200803776.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069572
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« Reply #16 on: November 09, 2013, 12:22:56 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: mehrkens jh, botzel k, steude u, et al. Long-term efficacy and safety of chronic globus pallidus internus stimulation in different types of primary dystonia. Stereotact funct neurosurg. 2009;87(1):8-17. Summary: this report describes a retrospective long-term analysis of 18 patients followed between 37 and 90 months suffering from dystonia. Patients had bilateral pallidal electrode implantation with permanent implantation of a stimulation system. Event: it was reported that patient experienced extreme psychosocial behavioral abnormalities necessitating intensive psychological treatment. With adequate physiological support, her clinical status stabilized. Please refer to manufacturer report number: 2182207200905195.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1489270
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« Reply #17 on: November 09, 2013, 12:23:22 PM »

Device Problem No Known Device Problem
Event Date 09/30/2009
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative

 
Event Description

Literature: zangaglia r, pacchetti c, pasotti c, et al. Deep brain stimulation and cognitive functions in parkinson's disease: a three-year controlled study. Mov discord. 2009; 24(11): 1621-8. Summary: this article presents a prospective, naturalistic controlled 3-year follow-up study of 65 consecutive patients with parkinson's disease (32 underwent stn-dbs implant, 33 were eligible, but chose other therapeutic procedures) enrolled from 2002 to 2003. The aim of the study was to assess the cognitive and behavioral effects of dbs of the stn in advance parkinson's disease. Motor and neuropsychological functions were assessed in all the subjects at baseline and 36 months. Dbs patients were also evaluated at 1, 6, 12, and 24 months after surgery. Reportable event: three years after implant one patient developed dsm-iv dementia. It was noted the pt's neropsychological evaluation and mmse score were at the lower limits of the normative range at baseline. At 36 mos, she showed a global decline in all the cognitive functions eval. There was also noted to be no evidence of significant improvement after dbs implant. Mri examination confirmed correct position of the electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1515436
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« Reply #18 on: November 09, 2013, 12:23:48 PM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 02/16/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: o'sullivan d, pell m. Long-term f/u of dbs of thalamus for tremor and stn for parkinson's disease. Brain res bull. 2009; 78(2-3): 119-121. Summary: dbs of the vim nucleus of the thalamus maintains long-term benefit for tremor due to essential tremor or to severe tremulous parkinson's disease. As far as bilateral stn stimulation, it maintains the benefit for the movement disorder aspect of parkinson's disease, such as tremor, rigidity and bradykinesia, but in the author's experience, does not prevent the progression of the disease and therefore is of no benefit for the non-dopaminergic aspects of the disease. Event: it was reported that the pt developed post-operative psychosis without previous psychiatric illness. The pt was concerned about having wires in her brain and they had to be removed. This resulted in resolution of her psychosis.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516505

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« Reply #19 on: November 10, 2013, 03:49:18 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Death   Patient Outcome  Death
Event Description

Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease: five year follow-up. J neurol. 2009; 256(2): 225-233. Summary: this study assessed the long-term efficacy and safety of bilateral subthalamic nucleus (stn) stimulation in patients with advanced parkinson's disease (pd). A total of 42 consecutive patients with idiopathic pd treated with bilateral stn stimulation were enrolled from november 1998 to june 2002. It was reported that one patient died 2 years after the surgery in a context of dementia. This patient had a normal mattis scale (score 132/144) at baseline, but the authors could not completely rule out the presence of mild cognitive impairment which could have been found using more extensive cognitive tests. See manufacturer report number: 2182207-2009-03228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1377936
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« Reply #20 on: November 10, 2013, 03:49:42 AM »

Device Problems Device remains implanted; Implant, reprogramming of
Event Date 05/31/2009
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description

Literature: glannon w. Stimulating brains, altering minds. J med ethics. 2009; 35(5): 289-292. Summary: the article presents a single pt case study with advanced parkinson's disease and describes the effect of deep brain stimulation (dbs) on the mind and how therapy influences decision by pts and physicians. Reportable event: it was reported that the pt was admitted to a psychiatric hospital for a manic state caused by stimulation three years after the implantation of electrodes in the subthalamic nucleus and the start of dbs. A mood stabilizer failed to control symptoms which included megalomania and chaotic behavior that resulted in serious financial debts. The pt became mentally incompetent. Adjustment of the stimulator resolved the mania and restored cognitive capacity for insight and rational judgement. This adjustment, however, resulted in a return of motor symptoms severe enough that the pt became bedridden. The pt and healthcare provider discussed options available which included admitting the pt to a nursing home because of the serious physical disability, despite intact cognitive and affective capacities; or to admit the pt to a chronic psychiatric ward because of a manic state, despite restoration of good motor function. In accord with the pt's competent expressed wish, he was legally committed to a chronic ward in a regional psychiatric hospital and continued to receive dbs therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1413992

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« Reply #21 on: November 10, 2013, 03:50:19 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/28/2009
Event Type  Death   Patient Outcome  Death
Event Description

Literature: chastan n, westby gw, yelnik, et al. Effects of nigral stimulation on locomotion and postural stability in pts with parkinson's disease. Brain. 2009;132(pt. 1):172-184. Summary: this study reports the effects of high frequency substantia nigra pars reticulata (snr) stimulation on locomotion and balance control during the gait initiation process, particularly the ability to brake the center of gravity fall during stepping which reflects postural control during gait, in seven parkinsonian pts operated for bilateral subthalamic nucleus (stn) stimulation with electrode contacts located within the snr. Between 1996 and 2005, parkinsonian pts were operated for bilateral stn stimulation. From the sample of all pts, some pts were retrospectively identified who satisfied the criterion of at least one contact (always the most ventral contact) of each quadripolar electrode located within the snr. Two pts suffered dementia, and were excluded, and two other pts were unwilling to participate. Event: one pt died. The cause of death was unk at the time of this report. Add'l f/u will be conducted. Refer to mfr report number: 2182207-2009-05171.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1422458
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« Reply #22 on: November 10, 2013, 03:50:50 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative

 
Event Description

Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease: five year follow-up. J neurol. 2009;256(2):225-233. Summary: this study assessed the long-term efficacy and safety of bilateral subthalamic nucleus (stn) stimulation in pts with advanced parkinson's disease (pd). A total consecutive pts with idiopathic pd treated with bilateral stn stimulation were enrolled from 1998 to 2002. It was reported that a pt experienced a left sided intracerebral hemorrhage during lead implantation surgery, with persistent aphasia. The pt subsequently developed dementia, and was lost to follow-up. See manufacturer report number: 2182207200903228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378208
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« Reply #23 on: December 08, 2013, 04:52:44 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id 7498, lot # unknown, product type extension. (b)(4).

 
Event Description
Mazzone, p. , brown, p. , dilazzaro, v. , stanzione, p. , oliviero, a. , peppe, a. , santilli, v. , insola, a. , altibrandi, m. Bilateral im plantation in globus pallidus internus and in subthalamic nucleus in parkinson's disease. Neuromodulation : journal of the international neuromodulation society. Summary: deep brain stimulation (dbs) of the subthalamic nucleus (stn) and of the pars interna of globus pallidus (gpi) is used to improve parkinsonian symptoms and attenuate levodopa-induced motor complications in parkinson¿s disease (pd) (dbs for pd study group, 2001). It is still not clear what the best anatomic structures to stimulate are or what the physiologic effects of dbs are. Most of the studies regarding dbs for parkinsonian symptoms have been conducted in patients with stn implantation, and these studies reported significant improvement in motor function with a relatively low rate of complication. The large experience of ablative surgery associated with the dbs experience of some groups worldwide indicate that gpi is a possible and very promising target for the management of parkinsonian symptoms. Surgical procedures have become safer and it is now possible, in selected cases, to target both structures in the same patient by means of the stereotactic system, ¿3p maranello¿ ((b)(4)). Using this system we were able to evaluate the clinical effects of simultaneous stimulation of both stn and gpi as well as evaluate the effects of isolated stimulation of each target. As it is known that there is a high intersubject variability of dbs, it seems relevant to test all different combinations of dbs in the same patient. We assessed the effects of dbs in 13 cases of pd, immediately after (30 min) stimulation and during chronic stimulation (weeks or months). Patients fell into two groups. The first (n= 7) responded to both gpi and stn stimulation equally. The second group (n= 6) was preferentially stimulated with only one target (stn = 5, gpi = 1). There was a good reduction in levodopa treatment following surgery. Most patients remained were chronically treated with bilateral stimulation of both targets. We conclude that dbs of stn and gpi was effective, with most patients treated chronically with both targets stimulated. Reported events: one patient experienced a hemorrhagic episode requiring surgical evacuation due to an arteriovenous malformation, which had not been detected during diagnostic neuroradiologic evaluation. The reporter stated that the patient suffered permanent right hemiparesis. One patient did not have correct positioning of electrodes on one side according to a postoperative mri. The reporter stated that the patient experienced somnolence, indifferentism, and a psychiatric disorder which were related to the wrong positioning of the left subthalamic electrode. It was noted that the electrode was repositioned later with the disappearance of these symptoms. Eight (8 ) patients experienced permanent weak phonation directly related to activation of deep brain stimulation (dbs). It was noted that these dbs related side effects were fundamentally linked to dbs of the subthalamic nucleus (stn), especially in patients with monopolar stimulation. The reporter stated that the side effects were not increased with simultaneous stimulation of both the stn and the globus pallidus internus (gpi). 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=3493031
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« Reply #24 on: December 09, 2013, 05:48:40 AM »

Model Number 7428
Event Date 02/27/2013
Event Type  Death   Patient Outcome  Death
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. Concomitant products: product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id 7428, serial# unknown, product type implantable neurostimulator; product id neu_unknown_lead, serial# unknown, product type lead. (b)(4).

 
Event Description
Eusebio, a. , witjas, t. , cohen, j. , fluchere, f. , jouve,e. , regis, j. , azuley, j-p. Subthalamic nucleus stimulation and compulsive use of dopaminergic medication in parkinson's disease. Journal of neurology, neurosurgery, and psychiatry. 2013;84(8 ):868-874. Doi: 1 0. 1136/jnnp-2012-302387. Summary: we conducted an observational study on 110 consecutive parkinsonian patients scheduled for stn dbs surgery. Patients were a ssessed preoperatively through extensive behavioral and psychiatric evaluations and divided into two groups: with or without compulsive dopaminergic medication use. Evaluations were repeated 1 year after surgery in both groups. Before surgery 18 patients (16. 3%) were compulsive dopamine users of whom 12 (10. 9%) fulfilled all criteria for dds. 90% of these patients also had at least one icd compared to 20% in the group without compulsive dopamine use. One year after surgery, one patient had persistent compulsive dopamine use, while no new occurrences were reported in the group without the condition before surgery. Stn dbs did not provoke any major psychiatric complications and icds were reduced in all patients. Our results suggest that stn dbs may reduce compulsive use of dopaminergic medication and its behavioural consequences. Whether this improvement is the result of stn dbs or the consequence of better treatment management remains to be established. Reported event: two patients experienced an intraparencymal hemorrhage and died. Two patients experienced an intraparencymal hemorrhage. Two patients had temporary removal of the stimulator due to hardware infection. One patient without dopamine misuse experienced transient confusion and a pulmonary embolism. One patient on l-dopa preoperatively added dopamine agonist postoperatively because of the emergence of apathy. One patient in the non-misuser group with no history of icd developed pathological gambling 6 months after surgery and after the introduction of low doses of dopamine agonists for apathy after surgery. Two patients in the non-misuser group with no history of icd developed excessive shopping after the introduction of low doses of dopamine agonists for apathy after surgery. One patient from the non-misuser group developed paranoid ideas and severe anxiety during the first year and attempted suicide. Patient had a history of major depression years before implant. 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=3312016
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« Reply #25 on: December 10, 2013, 04:11:16 AM »

Model Number 7428
Device Problem Device or device fragments location unknown
Event Type  Death   Patient Outcome  Death
Event Description
Pt's husband reports; in 2006, the pt passed away after prolonged troubleshooting during which time there was intermittent episodes of neurological impairment which the husband attributes to the activa dbs therapy. The pt was implanted with the dbs system in 2004. The pt reportedly had several neurological defecits immediately following, including obtundation, difficulty swallowing, paranoia, low voice volume and dementia which appeared to worsen when the therapy was on and would lessen when the therapy was off. The electrodes were eventually removed, however, the pt's condition continued to deteriorate. The pt eventually passed away at a nursing home while asleep. The mfr was unable to confirm the events, or the death, despite contact with doctor two different d a copy of the letter received from the pt's husband is attached. A follow up report will be sent if add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=752334
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« Reply #26 on: December 10, 2013, 04:13:39 AM »

Model Number 7428
Device Problem Device remains implanted
Event Date 10/13/2007
Event Type  Death   Patient Outcome  Death
Event Description
It was reported that a pt in a clinical research study had an episode of confusion with hallucinations and thought disorders necessitating prolonged hospitalization and pharmacological treatment post deep brain stimulator implant in 2007. This episode resolved at the end of the following month. No abnormalities of electrode parameters, contacts or locations were noted at that time. The therapeutic effects of dbs on his parkinson's disease (pd) symptoms were noted to be excellent. He had a psychiatric history remarkable for a single depressive episode 15 years earlier. Only after the postsurgical complication occurred, the wife and daughters of the pt stated that this episode was complicated by psychotic signs and agitation. Due to the postsurgical psychiatric complications, frequent follow-up visits with study doctors were scheduled; the patient was seen on five visits and had phone consultations when needed. The patient came to all visits except one. Three months later, the patient attempted suicide by intake of 6 pills of clozapine. He informed his wife, who contacted his general practitioner immediately. No medical intervention was deemed necessary and the general practitioner maintained phone contact throughout the following day and saw the participant the next day. He was dysarthric, bradykinetic, and had coordination difficulties at that time. The patient was seen by the general practitioner again on two days later, without any apparent clinical abnormalities. On the same day, the patient was seen by study doctors for the last time prior to his suicide. The patient complained of mild sleep problems and noted some problematic confrontations with his family. He was focused on resumption of professional work. His psychological examination showed no cognitive deficits; emotional modulation and resonance adequate; mood without evidence for depression; patient seemed somewhat strained; thinking without formal abnormalities. The participant did not mention his suicide attempt of three days earlier during that consultation. A week later, he was found by his spouse hanged in the family room. No note was found. His death was declared a suicide by legal authorities. According to a phone conversation with his daughter and spouse, the patient had been irritable and emotionally unstable before the onset of pd and was similarly, so after the surgery. The study doctors reported that the complete extent of the patient's psychiatric history was not communicated to them; neither before surgery, nor on the occasion of the prolonged postsurgical confusion, nor prior to the suicide attempt, nor after the suicide attempt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=952178
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« Reply #27 on: December 10, 2013, 04:14:27 AM »

Model Number 7428
Event Date 02/01/2012
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
 
Event Description
Additional information received reported that the cause of death was parkinson's progression and aspiration pneumonia. The patient also had a history of mania. The cause of death was not device related.

 
Manufacturer Narrative
Product id, 7482a51 lot# serial# (b)(4), implanted: 2009 (b)(6), explanted: 2012 (b)(6), product type extension product id, 7482a51 lot# serial# (b)(4), implanted: 2009 (b)(6), explanted: 2012 (b)(6), product type extension product id, 3387s-40 lot# v207484 serial#, implanted: 2009 (b)(6), explanted: product type lead product id, 3387s-40 lot# v207484 serial#, implanted: 2009 (b)(6), explanted: product type lead. (b)(4). Analysis results for neurostimulator model 7428 serial # (b)(4), showed no significant anomalies. Analysis results for extension, model 7482a, serial # (b)(4), showed no significant anomalies. Analysis results for extension, model 7482a, serial # (b)(4), showed no significant anomalies.

 
Event Description
The patient's death was reported. The cause of death was noted as parkinson's disease but it was unclear if the implantable neurostimulator (ins) caused or contributed to the death. Additional information was requested but was not available at the time of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2795593
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« Reply #28 on: December 10, 2013, 04:17:12 AM »

Model Number NEU_INS_STIMULATOR
Device Problem No Known Device Problem
Event Date 02/24/2011
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative
These exact dates were not provided and are an estimate based on the date the article was received for publication. It was not possible to match these events with previously reported events.

 
Event Description
Literature: a. M. Strutta, r. Simpsonb, j. Jankovica and m. K. Yorka,c. Changes in cognitive-emotional and physiological symptoms of depression following stn-dbs for the treatment of parkinson's disease. European journal of neurology 2012, 19: 121-127. Doi:1 0. 1111/j. 1468-1331. 2011. 03447. X summary: background and purpose: subthalamic nucleus deep brain stimulation (stn-dbs) has been shown to have beneficial effects on the motor features of parkinson's disease (pd), but its impact on non-motor symptoms, most notably mood, has not been fully explored. Methods: in the first study to independently compare the emotional-cognitive and somatic/physiological symptoms of depression, we examined mood differences in 17 bilateral stn-dbs and 22 matched non-surgical pd patients at baseline and 6 months. Results: the stn-dbs group reported higher levels of depression at baseline with significant endorsement of physical symptomatology. Postoperatively, no significant between-group differences in physical symptoms of depression were found. In contrast, a significant group by time interaction for cognitive-emotional symptoms of depression was found, with the stn-dbs group reporting an increase in psychological symptoms of distress. The stn-dbs group also reported an increase in anxiety following surgery. The suicide rate of 5% found in o ur study is consistent with other postoperative studies in pd. The impact of changes in levodopa and psychotropic medication are also explored. Conclusions: preliminary results suggest that the motor improvement often observed in patients with pd following bilateral stn-dbs may be partially offset by an increase in affective-cognitive symptoms of depression. The motor symptoms of parkinson's disease (pd) are the predominant outcome of investigation following subthalamic nucleus deep brain stimulation (stn-dbs). However, recent studies have described the potentially negative impact of stn-dbs on non-motor symptoms, such as the influences of poor mood state and cognition on overall quality of life (qol). A consensus regarding mood changes following stn-dbs has not been reached. Several studies investigating the psychiatric symptoms of patients following stn-dbs. Reported event: the increase in total depression scores for the stn-dbs group was a result of an elevation in cognitive-emotional symptoms of depression, most notably a rise in reported sadness, discouragement, failure, guilt, self-disappointment, selfcriticalness, and lack of interest. Overall the incidence of depression increased 12% for the stn-dbs patients following surgery for a total incidence rate of 56% of stn-dbs patients meeting criteria for at least mild depression. Moreover, the stn-dbs patients reported higher levels of situational and characterological anxiety at their 6-month evaluation. Of the original sample, two patients did not return for their follow-up because of a significant increase in depressive symptomatology as reported by their family, and one additional patient returned for his appointment, but refused to complete the full evaluation because of his poor mood state. One patient committed suicide three months post-surgery. The suicide was associated with a marked decrease in mood during the post-operative period without any specific triggers or stressors. Further information is being requested. A follow-up report will be submitted if additional information is received. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2446686
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« Reply #29 on: December 10, 2013, 04:19:26 AM »

Model Number 37603
Event Date 06/28/2012
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
 
Manufacturer Narrative
 
Event Description
Additional information received reported the patient underwent a psychology screening on (b)(6) 2011 prior to implant. The patient's diagnosis was refractory obsessive compulsive disorder (ocd), major depressive disorder (mdd), recurrent, and alcohol abuse in sustained remission. Clinical ratings demonstrated a y-bocs = 38. 0 (severe), ham-a = 36. 0 (severe), and ham-d = 35. 0. The patient had no major medical problems. During the clinical history and exam the patient reported passive suicidal thoughts with a clear contract for safety and longstanding sobriety. He denied any suicide attempts and denied sa treatment. It was later found that there had been a suicide attempt in the past. The patient was on valproate 1000 mg daily, fluvoxamine 100 mg daily, olanzapine 20 mg daily, lorazepam 1 mg 4 times daily, and propecia. The patient did not indicate use of lunesta or lithium during his neurology screening on (b)(6) 2012. During a follow up appointment on (b)(6) 2012 he admitted to poor compliance with the aforementioned medications, as well as heavier use of lorazepam for sleep. In addition, some of his medication doses were found to differ from what was previously indicated. During neuropsychological testing on (b)(6) 2012 the patient reported that he tried not to mix lorazepam with ethanol alcohol (etoh). During a psychiatric pre-op visit on (b)(6) 2012 (it was unclear if the reporter intended to indicate 2011 up to this point in the chronological timeline), the patient reported passive suicidal ideation, sobriety for years, and was no longer taking his antidepressant medications; he admitted to non-compliance since (b)(6) 2011. He also admitted to overuse of benzodiazepines in the past, despite reports of previously taking up to 12mg of lorazepam on occasion. The patient was tapered off his benzodia zepine as an outpatient. Electrode implantation was performed on (b)(6) 2011 at which time the patient rated his depression = 10, anxiety = 10, and ocd = 1 (lichert scale of 1-10). The patient also indicated passive suicidal ideation, contracting for safety; sobriety for years, and reported he had stopped lorazepam and showed no signs of symptoms of benzodiazepine withdrawal. Implantation of the bilateral generators occurred on (b)(6) 2011. At that time, he was prescribed hydroxyzine 25-50 mg four times daily for anxiety and chloral hydrate 1000 mg at bedtime as needed for insomnia. The implantable neurostimulator (ins) was activated during the first neurology post-op visit on (b)(6) 2011. At that time, depression= 7. 5, anxiety = 5. 0, and ocd = 4. 5, likely representing a lesion effect of the electrode implantation. There was little change in mood, since the patient reported his depression was unchanged, ocd was slightly better, and he felt very anxious. Initial settings were as follows, left: lead 0 negative - case positive, amplitude 2. 0v, pw 60. 0 microseconds, frequency 180. 0 hz; right: right vp: 0-c+; 3. 0; 60. 0; 180. 0. During the second neurology post-op visit on (b)(6) 2011 he noted no change in clinical symptoms and his device settings were changed to left: 0-c+; 2. 5; 60. 0; 190. 0, and right : 0-c+; 3. 5; 60. 0; 180. 0. At the next post-op appointment on (b)(6) 2011 the patient requested different settings. He felt 'jazzed' with the settings he had and turned the stimulator off, but then felt 'depressed' and turned it back on. The increase in energy represented hypothalamic stimulation so the settings were changed to left: 0-c+; 1. 5; 60. 0; 180. 0; and right : 0-c+, 2. 5, 60. 0, 180. 0. He continued to take hydroxyzine 25-50 mg four times daily and chloral hydrate 1500mg at bedtime as needed. A dose of diazepam 15mg at bedtime was added for sleep. The patient had subsequent programming performed during post-op visits on (b)(6) 2012. Voltage was minimized to avoid triggering mania, while pulse width and frequency were altered to maximize benefit. Settings on (b)(6) 2012 at the 6th monthly post-op visit were left: 0-/1+, 1. 5, 60. 0, 130. 0 right 0-/1+, 2. 5, 90. 0, 180. 0. Over these visits symptoms had been improving gradually. On (b)(6) 2012 the patient reported passive suicidal ideation, contracted for safety, and stated that he could not follow through with a suicide attempt due to religious beliefs. The patient again declined physician recommendation of maintenance antidepressant treatment. He had followed up with his primary psychiatrist, but only once. At this visit he requested and received zolpidem 10mg at bedtime instead of diazepam for sleep. On (b)(6) 2012, depression = 5. 0, anxiety = 5. 0, and ocd =5. 0. He also reported passive suicidal ideation and contracted for safety. The patient had been scheduled for a follow up visit on the date of the event. Follow up visits following implant demonstrated the device was preforming properly (sofstart active, battery voltage not indicating depletion, timer indicating that the device was active during the interval, impedances indicating that the electrode leads were functioning). Clinical observations indicated improvement in ocd symptoms (as well as anxiety and depression) following device activation. As previously stated, the patient's symptoms persisted until implant, improved somewhat, "and temporarily after implantation due to a lesion effect", then gradually improved as optimal settings were determined. The patient had received inpatient substance abuse treatment. He reported anxiety, depression, and passive suicidal ideation but insisted he could seek help if it worsened, had access to help, and did not report any worsening of suicidal thoughts. The physician indicated it was impossible to know with certainty, but did not believe the suicide was in any way caused by the device, and indicated "by virtue of the patient's longstanding illness, he was at risk for this outcome. " additionally, the psychiatrist did not think the event was related to the device because the patient had several known demographic and clinical factors that convey risk for suicide: chronic suicidality, diagnosis of mood disorder, refusing treatment of mood disorder, anxiety disorder, being single, being male, and living alone. Additionally, the patient's depression, anxiety, and ocd were improving as settings were optimized. The patient reported improvement at all prior follow up visits. The patient also did not appear to have any adverse effects from the device (mania, psychosis, or confusion) that would lead to an impulsive suicide attempt. The limited accounts of the suicide suggest that it was not impulsive and that he acted purposefully to maximize its success. The patient hung himself when family would not be present, left a suicide note (of which the last line read, "ocd won"), and led treating physicians to believe he could not carry through on the act due to religious reasons and that he would seek help before acting. It was indicated that his actions were "not consistent with a patient having adverse effects from a neurostimulator. ".

 
Manufacturer Narrative
 
Manufacturer Narrative
Product id 37085-60, lot#, serial# (b)(4), implanted: 2011 (b)(6), explanted: product type extension, product id 37085-60, lot#, serial# (b)(4), implanted: 2011 (b)(6), explanted: product type extension, product id 3391s-40, lot# v556815, serial#, implanted: 2011 (b)(6), explanted: product type lead, product id 3391s-40, lot# v556815, serial#, implanted: 2011 (b)(6), explanted: product type lead. (b)(4). Patient (b)(4) [suicide].

 
Event Description
It was reported that the patient unexpectedly committed suicide. The patient was being treated for severe obsessive compulsive disorder (ocd) and depression. It was further noted that the patient "seemed to be improving both in regards to his ocd and depression. ".

 
Event Description
A facility medwatch was received. No new information was reported. However, it was unclear if this was submitted by the physician directly to the fda.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2672165
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