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Author Topic: Deep brain stimulator - Mental Health  (Read 62989 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
« Last Edit: February 03, 2014, 01:37:33 AM by dennis100 » Logged
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« Reply #30 on: December 30, 2013, 07:27:45 AM »

Model Number 3387
Device Problems Explanted; Misplacement
Event Date 06/29/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The patient reported being hospitalized one week post implant. The patient reported no tremor symptom control. After being seen at the hcp office the patient was scheduled for surgery. Add'l info was requested and indicated that patient had a great deal of intraoperative anxiety. Post operatively, he experienced confusion, memory loss and some psychosis. All symptoms resolved within several days. The hcp was not able to obtain good tremor control for the patient intraoperatively. Do to the patient's high level of anxiety, the dbs lead was left at the "best guess target" and the case was halted. The hcp discovered post-operatively, a very slight bend in the cannula set that may have contributed to sub-optimal lead placement. Several attempts were made to reprogram the device for optimal symptom control. The cannula set was replaced and the patient underwent revision of the lead in september. The hcp was still unable to get good tremor control after multiple attempts. The system components were removed as the neurologist present during the surgery felt the tremor may be a typical and of unknown etiology. The event was not thought to be related to any equipment malfunction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=928656
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« Reply #31 on: December 31, 2013, 03:51:28 AM »

Model Number 3389
Device Problem Device remains implanted
Event Date 08/01/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The psychologist reports patient with parkinson's disease has developed confusion and delusions with reports of psychotic episodes subsequent to dbs system implant and system activation in 2006. The patient was reportedly hospitalized and admitted to a psychiatric unit two months later for one month prior to the reported event. The current patient status is unknown. The hcp attributed the reported patient complications to the dbs system and stated the patient did not have any of the psychiatric symptoms prior to bilateral dbs placement. The manufacturer physician consultant suggested shutting off the devices for 48 hours to see if the psychiatric symptoms resolve; the action is pending family consent. Additional information has been requested. No report of device explantation has been received by the manufacturer. A follow-up report will be sent when additional information has been received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=798963
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« Reply #32 on: December 31, 2013, 03:54:54 AM »

Model Number IPGNEURO
Device Problem Device remains implanted
Event Date 10/21/2006
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Hcp reports via clinical study report a patient being hospitalized on psychiatric unit, due to paranoid behavior. The patient began having suspicious thoughts. The patient saw an hcp who decreased requip medication two days earlier. The next day, the patient took the car and went driving, blocked an exit ramp because "people were trying to get him. " the patient was admitted to the hospital by police the next day. The patient is on the following medications at the time of the event: sinemet, comtan, requip, sildentil, buspar, trazodone, zocor, valium, generiac, mineral oil, vitamin b12, dhea. The hcp in characterizing the severity of the event as relatively serious, but manageable. The patient has had prior similar events. The patient was hospitalized in a psychiatric ward following dbs placement surgery starting in 2004 and resolved two months later. At this time the hcp reports this adverse event is possibly related to the parkinson's medication therapy, stimulator therapy, disease progression, dbs surgical procedure or history of paranoia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=786784
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« Reply #33 on: January 01, 2014, 05:14:13 AM »

Model Number 7428
Device Problems Device remains implanted; Unit inactivated
Event Date 08/21/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Hcp reports pt with parkinson's disease, and a history of anxiety and depression, developed mania in 2006 approx 1 mo after stimulator implant and device activation. Physician indicated the device was shut off and the pt started on seroquel medication. The pt's condition improved. The hcp indicated that they intend to gradually retry dbs therapy. No report rec'd of device explant or other surgical intervention and the product has not been returned to the mfr for analysis. Hcp reports the pt has subsequently recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=769298
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« Reply #34 on: January 02, 2014, 02:57:55 AM »

Model Number 3387
Device Problems Unknown (for use when the device problem is not known); No code available
Event Date 12/12/2005
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Hcp reported a pt in the (b)(6) study experienced confusion, psychosis, and hallucinations. A ct scan was performed, which showed no change. Carotid ultrasound showed no significant stenosis. Ekg showed a junctional rhythm. The pt was treated with medication changes and follow up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2803176
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« Reply #35 on: January 06, 2014, 09:18:47 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
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): four pts experienced psychosis (3 moderate, 1 severe) post dbs system placement. Post dbs system placement. Treatment and outcome info was not provided.

 
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, info on the medwatch form 3500a was completed by medtronic with info from the article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949254
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« Reply #36 on: January 08, 2014, 03:34:28 PM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The rep reported the pt is getting good therapeutic effect, but had shown signs of dementia and aggressiveness at last reprogramming session. Add'l info has been requested from hcp, but was not available on the date of the report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002284
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« Reply #37 on: January 08, 2014, 03:35:42 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: temel y, wilbrink p, duits a, et al. Single electrode and multiple electrode guided electrical stimulation of the subthalamic nucleus in advanced parkinson's disease. Neurosurgery 2007; 61 (5, suppl. 2) :346-357. The article describes the results of a study were 55 pts were treated for symptoms of advanced parkinson's disease with bilateral deep brain stimulation (dbs) of the subthalamic nucleus (stn). The purpose of the study was to evaluate intraoperative electrophysiological techniques related to microelectrode recording to determine if there was any affect on pt outcome. In one group of pts, a single microelectrode (not medtronic) was used and in the other group, multiple (up to five) microelectrodes (not medtronic) were used to establish the best positon to implant the permanent medtronic model 3389 dbs leads. In pts where the multiple microelectrode approach was used, the results demonstrated subtle deterioration in neuropsychological functions, particularly in memory function. These subtle changes in neuropsychological function were not determined to be significant based on interviews with pts and partners. Pts were assessed at 3 months and 12 months post dbs system placement. Add'l complications not specifically related to the microelectrode techniques were also included in the article. Four pts (leads n=4) experienced hypomanic symptoms following surgery. Treatment and outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1005233
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« Reply #38 on: January 08, 2014, 03:37:11 PM »

Event Type  No Answer Provided 
Event Description
Journal reference: fraix, et al. "clinical and economic results of bilateral subthalamic nucleus stimulation in parkinson's disease. " journal of neurology, neurosurgery, and psychiatry. 2006; 77(4): 443-449. The article discussed a prospective multicentre study in 95 consecutive parkinsons disease (pd) pts receiving bilateral stn stimulation and assessed its effects over 12 months. Pts were implanted with model 3389 lead and dbs neurostimulator (model 7424 or 7428). Reportable events: the 3389 lead (n=1) - one pt developed an intracerebral haematoma during electrode implantation resulting in permanent left hemiparesis with ongoing consequences for daily living. The electrode was not implanted. The 3389 lead (n=1) - one pt experience intracerebral haematoma during electrode implantation resulting in permanent frontal lobe dysfunction with increased dementia. The 3389 lead (n=3) - three pts developed an intracerebral haematoma and experienced temporary hemiparesis or confusion with complete remission within one week. The 3389 lead (n=1) - one pt experienced lead migration after three months requiring reimplant. The 3389 lead (n=1) and dbs extension (n=1) - one pt experienced one extension lead infection requiring the removal of all implanted devices and antibiotherapy. The pt was operated on 9 months later without sequelae. Neurostimulator (n=2) - two pts caught pneumonia in the immediate postoperative period. The 3389 lead (n=18) - nine pts experienced depression. The 3389 lead (n=4) - two pts experienced psychosis. The 3389 (=10) - five pts experienced hypomania. The 3389 lead (n=4) - two pt experienced apathy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921669
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« Reply #39 on: January 08, 2014, 03:38:06 PM »

Device Problem Device remains implanted
Event Type  Other 
Manufacturer Narrative
This report is being filed under exemption.

 
Event Description
Journal reference: chou, et al. "electroconvulsive therapy for depression in a parkinson's disease pt with bilateral subthalamic nucleus deep brain stimulator. " parkinsonism and related disorders. 2005; 11(6): 403-406. Several studies have suggested that stn stimulation can be associated with deleterious effects on mood, especially depression. In many cases, depressive symptoms occur within a month post-operatively and resolve either without specific therapy or with minor stimulator adjustments. This article suggests that ect can be a safe and effective option for severe depression in pd pts treated with stn dbs. Reportable event: unk dbs leads (n=2) - a female pt with advanced parkinsons disease developed a recurrence of major depressive with psychotic features after bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) surgery. Electroconvulsive therapy (ect) dramatically improved the depression without shifting electron position or damaging the dbs hardware.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921665
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« Reply #40 on: January 08, 2014, 03:38:52 PM »

Event Type  Other  
Manufacturer Narrative
This report is being filed under exemption.

 
Event Description
Journal reference: okun, md, et al. "management of referred deep brain stimulation failures. " arch neurology, 2005; aug: vol. 62 (8 ) p1250-1255. The article describes the experience of 41 patients complaining of suboptimal results from dbs surgery. The various causes for the suboptimal results were reported. Reportable events: the dbs lead (n=8) - eight patients experienced misplaced leads that were repositioned (patients 1, 23, 24, 31, 36, 39, 40). The dbs lead (n=3) - two patients experienced programming difficulties and misplaced leads that were repositioned (patients 27, 28, 38). The dbs lead (n=8) - eight patients experienced misplaced leads that were not repositioned (patients 3, 4, 12, 16, 20, 29, 33, 41). The dbs lead (n=3) - three patients experienced dementia and misplaced leads that were not repositioned (patients 2, 8, 9). The dbs lead (n=2) - two patients experienced misplaced leads that were not repositioned along with misdiagnosis (patients 13, 26).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921649
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« Reply #41 on: January 08, 2014, 03:41:17 PM »

Event Type  No Answer Provided 
Manufacturer Narrative
Follow-up is in process to establish specific event details and additional information will be submitted when available. The implantable pulse generators and leads were not identified by model or manufacturer.

 
Event Description
Journal reference: castelli, l. Et al. "chronic deep brain stimulation of the subthalamic nucleus for parkinson's disease: effects on cognition, mood, anxiety and personality traits. " european neurology. 2006; 55:136-144. The article describes the results of a study of 72 parkinsons disease patients (7 lost to follow-up) being treated with bilateral stn dbs therapy. The study evaluated a number of cognitive functions and behaviorial aspects following the initiation of dbs therapy. Reportable events: three patients showed cognitive decline along with: ipg (n=1), lead (n=2) one patient demonstrated psychosis. Ipg (n=1), lead (n=2) one patient demonstrated anxiety. Ipg (n=1), lead (n=2) one patient demonstrated anxiety and mood worsening. Ipg (n=2), leads (n=4) two patients showed worsening of depression. Ipg (n=7), leads (n=14) seven patients showed increase in anxiety (only). Ipg (n=3), leads (n=6) three patients showed a worsening of depression and anxiety. Ipg (n=1), lead (n=2) one patient experienced an increase in suicidal ideation. Ipg (n=17), leads (n=34) seventeen patients showed a decline in phonemic and/or category fluency. Note: since the cognitive and behavioral changes are presented by complication category it is not possible to ascertain if an individual patient may have experienced more than one category of the reported complications. Example: fluency decline and anxiety. The implantable pulse generators and leads were not identified by model or manufacturer.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=926832
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« Reply #42 on: January 08, 2014, 03:41:57 PM »

Model Number 3389
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 patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication.

 
Event Description
Journal reference: derost, et al. "is dbs-stn appropriate to treat severe parkinson disease in an elderly population?" neurology 2007; 68;17; p 1345-1355. The article describes the results of a retrospective a study comparing the effects, safety and quality of life in parkinsons patients younger than 65 and those 65 and older being treated with bilateral deep brain stimulation of the stn. Patients were followed for up to 2 years after surgery. The article reports a number of patient complications: reportable events: twelve patients (dbs leads n=12) experienced transient hypomania. In three cases the hypomania was clearly related to the stimulation parameters. No additional information on treatment and outcome was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=939856
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« Reply #43 on: January 08, 2014, 03:42:33 PM »

Model Number 3389
Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Mandat t. S. Et al. Case report "hypomania as an adverse effect of subthalamic nucleus stimulation: report of two cases", acta neurochirugica (wein) (2006) 148:895-898. The article describes a case study involving a male patient being treated for advanced parkinsons disease with bi-lateral stn dbs. The patient demonstrated unusual behavior (hypomania) two months post dbs implant. His wife reported he had broken into a car and had no explanation as to why. He also indicated he had an "over the top and invincible feeling". The hypomania was resolved with adjustments to the stimulation parameters delivered by both electrodes. No further hypomania was noted in the next six months.

 
Manufacturer Narrative
Report is on the left side lead (3389) of a two lead system. Journal reference: mandat t. S. Et al. Case report "hypomania as an adverse effect of subthalamic nucleus stimulation: report of two cases", acta neurochirurgica (wein) (2006) 148:895-898.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=931978
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« Reply #44 on: January 08, 2014, 03:43:29 PM »

Model Number 3389
Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal reference: mandat t. S. Et al. Case report "hypomania as an adverse effect of subthalamic nucleus stimulation: report of two cases", acta neurochirurgica (wein) (2006) 148:895-898. The article describes a case study involving a male patient being treated for advanced parkinsons disease with bi-lateral stn dbs. The patient demonstrated unusual behavior (hypomania) approximately one month post dbs implant. The patient purchased new car that he was unable to drive and arranged for a prostitute to visit his nursing home. Family indicated his actions did not match his pre-dbs implant personality. Hypomania was resolved with adjustments to stimulation mode and output parameters delivered by both electrodes. No further hypomania was observed over the next year.

 
Manufacturer Narrative
Report is on the right side lead of a bilateral system. Journal reference: mandat t. S. Et al. Case report "hypomania as an adverse effect of subthalamic nucleus stimulation: report of two cases", acta neurochirugica (wein) (2006) 148:895-898. See scanned pages.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=931979
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« Reply #45 on: January 08, 2014, 03:44:18 PM »

Model Number UNKN
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Journal reference: schupbach et al. "neurosurgery in parkinson disease, a distressed mind in a repaired body?" neurology "june 2006, 66:1811-1816. 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.

 
Event Description
Journal reference: schupbach et al. "neurosurgery in parkinson disease, a distressed mind in a repaired body?" neurology "june 2006, 66:1811-1816. The study objective is to assess the impact of chronic bilateral stimulation of the subthalamic nucleus (stn), on social adjustment in patients with parkinsons disease. The article describes results of a study involving patients. The patients were assessed for motor disability, cognition, psychiatric morbidity, quality of life, social adjustment and psychological status using unstructured in-depth interviews. They were assessed before and at 18 to 24 months after being treated with bilateral-stn dbs for advanced parkinson disease. Psychiatric disorders seen in patients were discussed. In two patients, panic disorder was observed at follow-up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=931984
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« Reply #46 on: January 08, 2014, 03:44:56 PM »

Model Number UNKNOWN
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: schupbach et al. "neurosurgery in parkinson disease, a distressed mind in a repaired body?" neurology "june 2006, 66:1811-1816. The study objective is to assess the impact of chronic bilateral stimulation of the subthalamic nucleus (stn), on social adjustment in patients with parkinson disease. The article describes results of a study involving patients. The patients were assessed for motor disability, cognition, psychiatric morbidity, quality of life, social adjustment and psychological status using unstructured in-depth interviews. They were assessed before and at 18 to 24 months after being treated with bilateral-stn dbs for advanced parkinson disease. Psychiatric disorders seen in patients were discussed. At follow-up, hypomania was observed in six patients.

 
Manufacturer Narrative
Journal reference: schupbach et al. "neurosurgery in parkinson disease, a distressed mind in a repaired body?" neurology "june 2006, 66:1811-1816. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=931985
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« Reply #47 on: January 08, 2014, 03:45:49 PM »

Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: schupbach et al. "neurosurgery in parkinson disease, a distressed mind in a repaired body"? neurology june 2006, 66:1811-1816. The study objective is to assess the impact of chronic bilateral stimulation of the subthalamic nucleus (stn), on social adjustment in patients with parkinsons disease. The article describes results of a study involving 29 patients. The patients were assessed for motor disability, cognition, psychiatric morbidity, quality of life, social adjustment and psychological status using unstructured in-depth interviews. They were assessed before and at 18 to 24 months after being treated with bilateral-stn dbs for advanced parkinsons disease. Psychiatric disorders seen in patients were discussed. Following surgery, seven patients had generalized anxiety disorder, however, the mean rating for mood and anxiety had improved significantly by the end of the study.

 
Manufacturer Narrative
Journal reference: schupbach et al. "neurosurgery in parkinson disease, a distressed mind in a repaired body"? neurology june 2006, 66:1811-1816. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=931986
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« Reply #48 on: January 08, 2014, 03:46:56 PM »

Event Type  No Answer Provided 
Manufacturer Narrative
Follow-up is in process to establish specific event details and additional information will be submitted when available. The implantable pulse generators and leads were not identified by model or manufacturer.

 
Event Description
Journal reference: castelli, l. Et al. "chronic deep brain stimulation of the subthalamic nucleus for parkinson's disease: effects on cognition, mood, anxiety and personality traits. " european neurology. 2006; 55:136-144. The article describes the results of a study of 72 parkinsons disease patients (7 lost to follow-up) being treated with bilateral stn dbs therapy. The study evaluated a number of cognitive functions and behaviorial aspects following the initiation of dbs therapy. Reportable events: three patients showed cognitive decline along with: ipg (n=1), lead (n=2) one patient demonstrated psychosis. Ipg (n=1), lead (n=2) one patient demonstrated anxiety. Ipg (n=1), lead (n=2) one patient demonstrated anxiety and mood worsening. Ipg (n=2), leads (n=4) two patients showed worsening of depression. Ipg (n=7), leads (n=14) seven patients showed increase in anxiety (only). Ipg (n=3), leads (n=6) three patients showed a worsening of depression and anxiety. Ipg (n=1), lead (n=2) one patient experienced an increase in suicidal ideation. Ipg (n=17), leads (n=34) seventeen patients showed a decline in phonemic and/or category fluency. Note: since the cognitive and behavioral changes are presented by complication category it is not possible to ascertain if an individual patient may have experienced more than one category of the reported complications. Example: fluency decline and anxiety. The implantable pulse generators and leads were not identified by model or manufacturer.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=926832
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« Reply #49 on: January 08, 2014, 03:48:02 PM »

Event Type  No Answer Provided 
Event Description
Journal reference: anderson, v. C. , et al. "pallidal vs. Subthalamic nucleus disease stimulation in parkinson disease. " arch. Neurol. 2005; 62: 554-560. The article describes a randomized, blinded pilot comparison of the safety and efficacy of stn and gpi stimulation in 23 pts with advanced idiopathic parkinsons. The pts were implanted bilaterally with dbs lead (model 3382 or 3387) and neurostimulator (model itrel 2 or soletra). Reportable events: lead (n=2) - one female pt experienced unexplained severe pd progression after 6 months of dbs therapy. She was treated with antibiotics for recurrent utis. At 12 months she was severely badykinetic and rigid, unable to communicate and had difficult swallowing. Lead (n=2) - one pt experienced ischemic stroke with persistent neurologic deficit. Lead (n=2) - one pt experienced extracranial lead fracture after falling. Lead (n=2) - one pt experienced memory deficits, difficulty concentrating and apathetic mood within weeks of surgery that persisted throughout therapy. Lead (n=6) - three pts experienced delirium. Lead (n=4) - two pts experienced anxiety. Lead (n=2) - one pt had mild visual field defects. Lead (n=2) - one pt experienced hallucinations.

 
Manufacturer Narrative
This report is being filed under exemption.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921676
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« Reply #50 on: January 09, 2014, 09:44:13 AM »

Model Number 3387
Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Journal reference: cilia et al. "brain networks underlining verbal fluency decline during stn-dbs in parkinson's disease: an ecd-spect study" parkinsonism & related. The study evaluated patients with parkinson's disease preoperatively and 12 months after stn-dbs. Clinical and cognitive data were compared with 12 matched pd patients who had not undergone surgery. One patient developed hypomanic behavior following the start of dbs therapy. Outcome informed was not provided.

 
Manufacturer Narrative
Journal reference: cilia et al. "brain networks underlining verbal fluency decline during stn-dbs in parkinson's disease: a study" parkinsonism & related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979648
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« Reply #51 on: January 09, 2014, 09:44:47 AM »

Model Number 3387
Device Problems Explanted; Unknown (for use when the device problem is not known)
Event Date 11/05/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported the device did not work and the pt had psychotic episodes. Additional info has been 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.

 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=977185
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« Reply #52 on: January 09, 2014, 09:45:52 AM »

Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: winge et al. "lower urinary tract symptoms and bladder control in advanced parkinson's disease: effects of deep brain stimulation in the subthalamic nucleus" movement disorders: 2007/22/2/220-225. In this prospective study they evaluated bladder symptoms and bladder control using questionnaires and urodynamics in a group of patient with pd with implantation of electrodes in the stn. Reportable event: one patient developed psychosis following dbs implant and before postoperative urodynamic evaluation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=978839
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« Reply #53 on: January 09, 2014, 09:47:27 AM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Death   Patient Outcome  Death
Event Description
Journal reference: vesper, et al. "subthalamic nucleus deep brain stimulation in elderly patients -- analysis of outcome and complications. " bmc neurology, 2007; 7(7):1-9. The article describes the results from a retrospective study that involved a series of patients treated with bilateral deep brain stimulation (dbs) for management of symptoms related to idiopathic parkinsons disease. The study objective was to better understand how patient age affects the therapy outcome and determine if there should be an age limit on dbs therapy. Patient follow-up was performed every 6 months for two years. A total of complications were noted involving patients. Complications were defined as events that prolonged the patient hospital stay and/or caused significant morbidity. Reportable event: one male patient developed transient a stimulation dependent manic-depressive state following surgery. Symptom relief (tremor control) was limited due to the psychic symptoms and his condition continued to deteriorate. He committed suicide at 15 months post dbs therapy initiation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=980823
« Last Edit: February 03, 2014, 01:38:25 AM by dennis100 » Logged
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« Reply #54 on: January 09, 2014, 09:48:22 AM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: vesper, et al. "subthalamic nucleus deep brain stimulation in elderly patients -- analysis of outcome and complications. " bmc neurology, 2007; 7(7):1-9. The article describes the results from a retrospective study that involved a series of patients treated with bilateral deep brain stimulation (dbs) for management of symptoms related to idiopathic parkinsons disease. The study objective was to better understand how patient age affects the therapy outcome and determine if there should be an age limit on dbs therapy. Patient follow-up was performed every 6 months for two years. A total complications were noted involving some patients. Complications were defined as events that prolonged the patient hospital stay and/or caused significant morbidity. Reportable event: eleven patients (leads n=11) experienced transient mental changes, the most common was dysarthria. Some adjustments to the stimulation parameter settings were conducted without diminishing therapy benefits. No additional treatment and outcome information were provided. The author speculated that the mental changes may have been more related to medication reduction and operative stress.

 
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 were not provided. It is possible that each patient may have experienced more than one complication.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=980799
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« Reply #55 on: January 09, 2014, 09:49:14 AM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: vesper, et al. "subthalamic nucleus deep brain stimulation in elderly patients -- analysis of outcome and complications. " bmc neurology, 2007; 7(7):1-9. The article describes the results from a retrospective study that involved a series of 73 patients treated with bilateral deep brain stimulation (dbs) for management of symptoms related to idiopathic parkinsons disease. The study objective was to better understand how patient age affects the therapy outcome and determine if there should be an age limit on dbs therapy. Patient follow-up was performed. A total of 27 complications were noted involving 20 patients. Complications were defined as events that prolonged the patient hospital stay and/or caused significant morbidity. Reportable event: three patients (dbs leads n=3) experienced persistent mental changes. No treatment and outcome information was provided. "the author speculated that the mental changes may have been".

 
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=980797
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« Reply #56 on: January 09, 2014, 09:49:59 AM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: montaurier c, morio b, bannier s, et al. Mechanisms of body weight gain in pts with parkinsons disease after subthalamic stimulation. Brain. 2007; 130(pt. 7): 1808-1818. The article describes the results of a study involving 24 pts being treated with bilateral deep brain stimulation (dbs) for symptoms related to advanced parkinsons disease. The goal of the study was to evaluate post surgery weight gain. In addition, a number of complications unrelated to weight gain are presented in the article. One pt suffered from transient hypomaina following dbs surgery. Treatment and additional outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982852
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« Reply #57 on: January 09, 2014, 09:51:06 AM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Death   Patient Outcome  Death
Event Description
Journal reference: schupbach m, welter ml, bonnet am, et al. Mortality in patients with parkinsons disease treated by stimulation of the subthalamic nucleus. Mov disord. 2006; 22(2):257-261. The article describes the results of a study involving 171 patients being treated with bilateral deep brain stimulation (dbs) for symptoms related to advanced parkinson disease. The goal of the study was to assess mortality and causes of death. Study patients were evaluated until death or july 2005. Foreign mortality rates and united states historical comparisons were used. Sixteen patients died during the study period. Eight deaths were classified as unrelated to dbs treatment. Two were thought to have some relationship to dbs treatment and the six remaining could not rule out the possibility of some relationship to dbs therapy. A male pt expired due to pneumonia secondary to a car accident related to his hypomania. Excessive l-dopa (patient had self regulated) might have resulted in the hypomania.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=986258
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« Reply #58 on: January 09, 2014, 09:51:55 AM »

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: schupbach m, maltete d, houeto jl, et al. Neurosurgery at an earlier stage of parkinson disease: a randomized, controlled trial. Neurology. 2007; 68 (4): 267-271. The article describes the results of a study involving pts being treated with bilateral or unilateral deep brain stimulation (dbs) for symptoms related to advanced parkinsons disease. The goal of the study was to assess whether surgery at an early stage would maintain quality of life as well as improve motor function. The pts had parkinsons disease for a short duration 6. 8 years plus or minus 1 year. Pts were assessed at 6, 12 and 18 months. Some patient complications were noted during the study. One pt whose parkinsonian signs had almost completely disappeared after surgery developed a somatoform disorder. Whether stimulation was the cause could not be ascertained. Treatment and additional outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=986243
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« Reply #59 on: January 09, 2014, 09:52:33 AM »

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: schupbach m, maltete d, houeto jl, et al. Neurosurgery at an earlier stage of parkinsons disease: a randomized, controlled trial. Neurology. 2007; 68 (4): 267-271. The article describes the results of a study involving patients being treated with bilateral or unilateral deep brain stimulation (dbs) for symptoms related to advanced parkinsons disease. The goal of the study was to assess whether surgery at an early stage would maintain quality of life as well as improve motor function. The pts had parkinsons disease for a short duration 6. 8 years plus or minus 1 year. Pts were assessed at 6, 12 and 18 months. Some pt complications were noted during the study. Five pts (leads n=5) and transient hypomania following dbs surgery. Treatment and additional outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=986242
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« Reply #60 on: January 09, 2014, 09:53:59 AM »

Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: aybek, et al. "long -term cognitive profile and incidence of dementia after stn-dbs in parkinson's disease. " mov discord. 2007; 22 (7): 974-981. The article described a study to evaluate long-term cognitive profile and incidence of dementia in 57 subjects with bilateral subthalamic nucleus dbs for parkinson's disease. Reportable event: five (5) pts with bilateral stn-dbs fulfilled dementia criteria when examined by the neurologist 6 months post-surgery. These pts worsened in almost all cognitive domains, significantly for the global memory score. The 3 year follow-up revealed an incidence of dementia after stn-dbs similar to those reported in medically treated pts. However, 36% of pts developing dementia did, so within 6 months from implantation surgery suggesting a precipitating effect of the stimulation. Correct lead location was confirmed in all pts that were controlled by postoperative mri.

 
Manufacturer Narrative
Journal reference: aybek, et al. "long -term cognitive profile and incidence of dementia after stn-dbs in parkinsons disease. " mov disord. 2007; 22(7): 974-981.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991659
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« Reply #61 on: January 09, 2014, 09:54:35 AM »

Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: aybek et al. "long-term cognitive profile and incidence of dementia after stn-dbs in parkinson's disease. " mov disord. 2007; 22(7): 974-981. The article describes a study to evaluate long-term cognitive profile and incidence of dementia in 57 subjects with bilateral subthalamic nucleus dbs for parkinson's disease. One patient with bilateral stn-dbs had a transient complication of acute paranoid state with no further information being reported on this event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991652
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« Reply #62 on: January 09, 2014, 01:48:09 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: wider c, pollo c, bloch j, burkhard pr, vingerhoets fjg. Long-term outcome of 50 consecutive parkinson's disease patients treated with subthalamic deep brain stimulation. Parkinsonsim relat disord 2008;14(2):114-119. The authors describe the long-term outcome in 50 consecutive advanced parkinson's disease (pd) patients treated with subthalamic nucleus deep brain stimulation (stn-dbs). Assessments were carried out at baseline, 6 months, 2 years, and 5 years postoperatively. Stn-dbs is an effective treatment for advanced pd patients, and the beneficial effect is maintained at 5 years. However, worsening occurs over time due to disease progression. Thirty seven patients were available for clinical evaluation at 5 years. Reportable event: early adverse events included acute paranoid psychosis in one pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053677
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« Reply #63 on: January 09, 2014, 01:48:39 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: wider c, pollo c, bloch j, burkhard pr, vingerhoets fjg. Long-term outcome of 50 consecutive parkinson's disease patients treated with subthalamic deep brain stimulation. Parkinsonsim relate disord 2008;14 (2):114-119. The authors describe the long-term outcome in 50 consecutive advanced parkinson's disease (pd) patients treated with subthalamic nucleus deep brain stimulation (stn-dbs). Assessments were carried out at baseline, 6 months, 2 years, and 5 years postoperatively. Stn-dbs is an effective treatment for advanced pd patients, and the beneficial effect is maintained at 5 years. However, worsening occurs over time due to disease progression. Thirty seven patients were available for clinical evaluation at 5 years. Reportable event: dementia developed 29 + / - 22 months after surgery in 11 patients.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053658
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« Reply #64 on: January 12, 2014, 04:45:04 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: d. Fontaine et al. "subthalamic nucleus stimulation using a fisher zd stereotactic frame mr-ct fusion guidance and preoperative orthogonal radiographs, in parkinson's disease" neurochirurgie 53 (2007) 463-469. The article describes the method and results of a technique to implant electrodes in the stn for treatment of pts with idiopathic parkinson's disease. Sixty (60) pts with motor fluctuations and/or dopa-induced dyskinesia had the stn bilateral implantation surgery. Several complications were reported as noted below. Reportable event: long-term results showed temporary hypomania reported in 3 pts.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015216
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« Reply #65 on: January 12, 2014, 04:46:08 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Kalteis, k. , et al. Influence of bilateral stn-stimulation on psychiatric symptoms and psychosocial functioning in pts with parkinson's disease/journal of neural transmission/2006/113/9/1191-1206. The article describes a study where the authors investigated the effects of dbs subthalamic stimulation on psychiatric symptoms and psychosocial functioning in pts with parkinson's disease. Some pts were assessed three times prior to surgery and at three, nine weeks as well as three, six and twelve months after surgery. Some post stimulation complications were noted. During implantation of the dbs electrodes, one pt with parkinsons disease experienced a psychotic episode. The pt required antipsychotic treatment.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1016655
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« Reply #66 on: January 12, 2014, 04:46:44 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
This report is being submitted following an internal audit.

 
Event Description
Literature: tabbal/safety and efficacy of subthalamic nucleus deep brain stimulation performed with limited intraoperative mapping for treatment of parkinson's disease 2007/61/3/119-27. This single-center study implanted 110 patients with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for the treatment of parkinson's disease. The objective of the study was to establish the safety and efficacy of bilateral stn-dbs performed during an expedient procedure with limited intraoperative mapping. The investigators used t2-weighted magnetic resonance imaging guidance to target the stn. Adverse events are reported. Two patients with pre-operative mild cognitive abnormalities were disoriented immediately after surgery for several days and then developed progressive dementia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018987
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« Reply #67 on: January 12, 2014, 04:47:40 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: tir et al. "exhaustive, one-year follow-up of subthalamic nucleus deep brain stimulation in a large, single-center cohort of parkinson's pts. " 2007/61/2/297-304. This article describes a study that enrolled 103 consecutive pts with parkinson's disease who were treated with bilateral stn-dbs. The pts were followed for a period of 12 mos. Reportable event: sixteen pts exhibited transient postoperative delirium, ranging from temporospatial disorientation to psychosis, that resolved in a few days 14 pts and in a few weeks in the remaining 2 pts. No pts required antipsychotic treatment.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019015
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« Reply #68 on: January 12, 2014, 04:48:12 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Journal reference: tir et al. "exhaustive, one-year follow-up of subthalmic nucleus deep brain stimulation in a large, single-center cohort of parkinson's pts. " 2007/61/2/297-304. This article describes a study that enrolled 103 consecutive pts with parkinson's disease who were treated with bilateral stn-dbs. The pts were followed for a period of 12 mos. Reportable event: three pts exhibited behavioral disorders with one case of dopaminergic psychosis at 6 months.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019027
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« Reply #69 on: January 12, 2014, 04:49:55 PM »

Model Number 7426
Device Problem Explanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported, the pt required removal of bilateral dbs sys implants due to complications from infection; both systems had been removed due to infected hardware. The right-sided sys was explanted in 2008, and the left-sided sys was removed ten days later. Review of consultation notes shows that subsequent to explant, his condition had deteriorated; he had worsening dystonia and had suffered aspiration pneumonia, hypoxia, and mental status changes. While being treated with antibiotics, the pt was taken off of antidepressant medications and had been significantly depressed with suicidal ideation. Post-explant, the pt had also received physical and occupational therapy; he experienced extensive body spasms throughout the day and received treatment with medications. At follow-up in 2008, symptoms of muscle spasms, posturing and dystonia motion were noted. The pt had good muscle strength and was alert and followed commands. A limited medication list showed treatment with flexeril, baclofen, artane, and clonazepam, ambien, oxycontin, habitrol, linezoid, neurontin, tylenol and ibuprofen. The pt had "failed with deep brain stimulator" therapy and injections with botox would be considered. The hcp reported on 03/05/2008, it was unk if the pt continued to receive antibiotic therapy; he was being managed with oral medications for dystonia. It was unk if a dbs sys would be re-implanted. Refer to mfr report #6000153200800133, #6000153200800786, and 3004209178200801577.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019444
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« Reply #70 on: January 12, 2014, 04:50:41 PM »

Model Number 3389
Device Problem Device remains implanted
Event Date 12/12/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Information received indicated the patient experienced maniac psycho-motor agitation and dyskinesia fifteen minutes after the neurostimulator was turned on. It is unknown as to why the neurostimulator had been turned off. The product will not be explanted. The hcp intends to manage the adverse event. The patient outcome is unknown. Refer to medwatch report# 6000153-2008-01694. The patient has been enrolled in a clinical study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022030
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« Reply #71 on: January 13, 2014, 09:11:34 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. Four pts (lead n=4) experienced a combination of 7 neuropsychological side effects that included (depression in 2 pts, hypomania/mania 2 pts, psychosis in 1 pt and impulse control problems in 2 pts). Some pts experienced more than one side effect. Treatment and outcome info was not provided. Note: from the data presented in the article, it was not possible to determine which side effects were linked with each of the 4 pts.

 
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008135
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« Reply #72 on: January 13, 2014, 09:12:17 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Journal reference tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61(5): e1024-e1030.

 
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61(5):e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. One pt experienced hypomania and impulse control problems. Treatment and outcome info was not provided.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008136
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« Reply #73 on: January 13, 2014, 09:13:59 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

 
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. A man being treated with unilateral deep brain stimulation (dbs) for symptoms related to tremor-dominant parkinsons disease developed hypomania, general anxiety and l-dopa drug abuse within 3 months of stimulation. Motor control with stimulation on remained good. Medication induced a severe uncontrollable dyskinetic movement. He was taking 4mg of pramipexole and 8mg of trihexyphenidyl per day after psychiatrist consultation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008137
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« Reply #74 on: January 13, 2014, 09:15:33 AM »

Model Number 3387
Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Other
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. A man being treated with bilateral deep brain stimulation (dbs) for symptoms related to parkinsons disease developed a manic episode 3 months post surgery, which was characterized by irregular social activities, poor relationships with family, irritable mood, decreased need for sleep, inflated sense of self-importance, racing thoughts and increased goal-directed activity. Post operative mri showed that the active contact of the left electrode might be located at or near the anterior ventral-medial tip of the stn. The mania subsided after a parametric adjustment in the stimulation level. In addition, the pt's levodopa was decreased by 33%.

 
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008138
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« Reply #75 on: January 13, 2014, 09:16:51 AM »

Model Number 3387
Device Problems Misplacement; Implant, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

 
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts, who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. A man being treated with bilateral deep brain stimulation (dbs) for symptoms related to parkinsons disease experienced psychosis with violent behavior, jealousy and persecutory delusions 6 months after increasing the left-side amplitude to 3v. The pt was admitted to the psychiatric ward and the dbs device was deactivated. Mri showed the tip of the left electrode was located outside the stn boarder. Surgical revision of the electrode resulted in resolution of the pt's delusions for the next 3 yr follow-up period.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008139
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« Reply #76 on: January 13, 2014, 09:59:57 AM »

Model Number 7424
Device Problems Loss of power; Low battery
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
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. See scanned pages.

 
Event Description
Journal reference: anheim m, fraix v, chabardes s. Krack p. Benabid a-l, pollak p, lifetime of itrel ii pulse generators for subthalamic nucleus stimulation in parkinsons disease. Mov disord 2007;22(16):2436-2439. The article describes the results of a long term study where 49 pts were treated for symptoms of advanced parkinsons disease with bilateral deep brain stimulation (dbs) of the subthalamic nucleus (stn). The purpose of the study was to evaluate the lifetime of chronic stimulators (itrel ii). A number of adverse events related to stimulator end-of-life (normal battery depletion) were included in the article. Unilateral ipg and end-of-life led to sudden and severe aggravation of parkinsonian symptoms in 10 pts. Unilateral ipg end-of-life led to psychosis, including delirium, hallucinations and agitation in two pts.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008125
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« Reply #77 on: January 13, 2014, 10:00:33 AM »

Model Number 3389
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 12/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt's spouse reported the pt has had mood/attitude changes since deep brain stimulation surgery in late 2007. The pt's current status is fair. The mfr redirected the caller to contact the pt's health care professional. Add'l info was requested from the health care professional (hcp). The hcp reported the pt's diagnosis is hypomania. The pt's symptoms included psychological changes. Per the hcp, the pt was reprogrammed ("moved away from ventral contacts"). The pt was seen by psychiatry and will be re-evaluated at follow-up.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009689
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« Reply #78 on: January 14, 2014, 11:28:45 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
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 #79 on: January 14, 2014, 11:29:28 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
 
Event Description
The patient had been hospitalized for psychological problems in the last few months. The family was concerned the patient's deep brain stimulation system may be causing some of the problems. Current impedance measurements were normal. All therapy impedances and current measurements were in the normal range and consistent with the last few visits at the clinician's office. Counters had been checked and it did not appear that the devices had been affected by emi. The battery voltage of the devices was also appropriate; 3. 72 on the right and 3. 74 on the left. Additional information has been requested, a follow-up report will be sent if additional information becomes available. See manufacturer's report # 3004209178200806241.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1181213
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« Reply #80 on: January 14, 2014, 08:01:58 PM »

Model Number 7428
Device Problem Device remains implanted
Event Date 09/01/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that following the second phase of the dbs implant surgery, the patient developed psychiatric problems. When the device was turned on, the patient's mental status changed and exhibited signs of a psychotic disorder. His wife stated "the patient actually came after her and got physical with her". The patient's symptoms "got so bad" he was hospitalized in 2007, and again in 2008. The patient's wife requested they turn the stimulator off to see if this was the problem. He immediately started to get better. The pt was in a nursing home, and later was released home. 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=1213288
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« Reply #81 on: January 14, 2014, 09:09:13 PM »

Model Number 3387IES
Event Date 10/14/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Subject 002 came in to see dr. Malone - psychiatrist - for an urgent visit. This was not a regularly scheduled research visit. Subject was very different than on past visits. Clearly psychotic about family situation. Does state that family has been very negative towards her. Dr. Malone was very concerned for her safety. Given her psychotic thinking, she was not able to contract for safety. Subject 002 was transported to lutheran hosp for psych admission. Overall, her depressive symptoms were improved versus baseline. It appears that the substantial stressors recently have brought about psychotic symptoms. Hopefully, the addition of some antipsychotic meds and mostly some inpatient therapy will be helpful in reorganizing her thinking. Dbs system was intact and functional. She has had emotional decompensation in the past during times of increased stress. Currently has severe family stressors leading to this. Not suicidal. Turning off dbs results in significant worsening of mood and symptoms. Therefore, dbs is still providing benefit and not causing symptoms. Dbs system implanted in 2005. Battery -ipg- replacements: two times in 2006, 2007, 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1194485
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« Reply #82 on: January 14, 2014, 11:04:27 PM »

Model Number 7426
Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: merello m, tenca e, lloret sp, et al. Prospective randomized 1-year follow-up comparison of bilateral subthalamotomy versus bilateral subthalamic stimulation and the combination of both in parkinson's disease pts: a pilot study. Br j neurosurg. 2008;22(3):415-422. It has been suggested that potential risk of hemiballismus after subthalamotomy makes dbs preferable to ablation for ipd treatment; however, cost and the need for regular electrode control have also been observed as disadvantages to stimulation. The objective was to compare efficacy and safety of different surgical approaches to stn, in a prospective randomized pilot study. The 16 consecutive ipd pts randomized to receive either: bilateral stn-dbs (bs group), bilateral subthalamotomy (bl group), or unilateral subthalamotomy plus contralateral stn-dbs implantation (l/s group), and followed for 12 months after surgery. Reportable event: two pts from the bs group in whom more dorsal contacts had been activated, presented a clinical condition during initial programming stages characterized by irritability, excitation, paranoia and severe insomnia progressing in hours, and reverting completely after changing stimulation parameter settings. See mfg report 2182207200805745.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161213
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« Reply #83 on: January 16, 2014, 05:23:56 AM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced cognitive issues and 'dangerous' personality changes. He was getting some relief from the tremors but felt manic. The amplitude of his deep brain stimulator was too high and needed fine turning. 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=1226582
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« Reply #84 on: January 16, 2014, 05:25:10 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: raucher-chene d, charrel cl, de maindreville ad, limosin f. Manic episode with psychotic symptoms in patient with parkinson's disease treated by subthalamic nucleus stimulation: improvement on switching the target. J neurol sci. 2008; 273(1-2): 116-117. We report the case of a patient with parkinson's disease (pd) who presented a manic episode with psychotic symptoms, secondary to dbs that improved with a change in the target stimulated. Reportable event: one year later, the patient, (b)(6) male, was hospitalized for a manic episode with psychotic features. Divalproex and aripiprazole were prescribed. Concomitantly, the stimulation voltage was reduced (1,7 v on both sides), inducing deterioration of the motor status. The patient displayed less psychomotor agitation but he continued to display some emotional lability and megalomaniac delusions. The stimulated target on the right side was thus switched to the most distal placement. This improved the remaining manic symptoms. Two months later, despite an increase in voltage to maintain motor benefits, manic symptoms have not recurred. See mfg report # 2182207-2008-07300.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1226505
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« Reply #85 on: January 16, 2014, 05:26:51 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: raucher-chene d, charrel cl, de maindreville ad, limosin f. Manic episode with psychotic symptoms in a patient with parkinson's disease treated by subthalamic nucleus stimulation: improvement on switching the target. J neurol sci. 2008; 273 (1-2): 116-117. We report the case of a patient with parkinson's disease (pd) who presented a manic episode with psychotic symptoms, secondary to dbs that improved with a change in the target stimulated. Reportable event: a man with an eight-year history of pd had medication-resistant physical symptoms suitable for stn dbs treatment. He had a history of one major depressive episode. Just after stimulation, a marked improvement in motor symptoms was observed. Concomitantly, the patient started to develop hypomanic symptoms with insomnia, irritability, elevated mood and increased goal-directed activity. These symptoms did not improve on valpromide treatment (900 mg/day) and it was decided to move the lead contacts on both sides to more distal placements, further from the medial part of the stn. This modification led to remission of the hypomanic symptoms, with stabilisation of the neurological state. Valpromide was discontinued six months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1226503
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« Reply #86 on: January 16, 2014, 05:27:56 AM »

Model Number 7426
Device Problems Lead(s), breakage of; Other (for use when an appropriate device code cannot be identified); Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 08/01/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
The patient was admitted to a care facility with psychosis. It was reported that the implantable neurostimulator was turning on and off when the patient used the television at a care facility. The hcp reported that the 'wires broke'. X-ray results were pending. The patient experienced tremors, dyskinesia, and slow movement associated with the event. The outcome was reported as 'pending'. A follow-up report will be submitted if additional information becomes available. Please see mfr report # 3004209178-2008-07383.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1229992
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« Reply #87 on: January 18, 2014, 12:11:30 AM »

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 #88 on: January 18, 2014, 02:24:27 PM »

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 #89 on: January 19, 2014, 06:02:33 PM »

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
Manufacturer Narrative
 
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 #90 on: January 19, 2014, 06:03:38 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 #91 on: January 19, 2014, 06:06:02 PM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 06/30/2009
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Literature: coenen va, honey cr, hurwitz t, et al. Medial forebrain bundle stimulation as a pathophysiological mechanism for hypomania in subthalamic nucleus deep brain stimulation for parkinson's disease. Neurosurgery. 2009;64(6): 1106-1115. Summery: this article presents prospective study of six consecutive patients between 2007 and early 2008 who underwent bilateral stn dbs surgery for advanced parkinson's disease. The study hypothesized that stimulation-induced acute hypomania was the results of inadvertent axonal activation of the medial forebrain bundle (mfb), which is located in the proximity of, but outside the limbic stn. Reportable event: it was reported that the patient's family contacted the doctor ten days after reprogramming because of extraordinary behavior that had started shortly after the change of stimulation to the deeper electrode contact (ec). The pt had started to wear his wife's clothes, demanded sexual intercourse daily, and showed increased risk-taking behavior, particularly reckless driving. The pt was admitted to the hospital. He appeared agitated and understood that his behavior was wrong, but he explained that "something was driving" him. Stimulation was shut off and his urges stopped almost instantaneously. At that time, the family reported, for the first time, that a year previously, while taking the medication pramipexole, a similar but less-pronounced sexual fetish behavior had transiently occurred, which resolved with discontinuation of the medication. During that hospital stay, the stimulation was reinitiated using a bipolar stimulation mode, lower amplitude, and more superficial contact settings. This setting improved his motor symptoms and did not result in an acute hypomanic episode.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1443482
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« Reply #92 on: January 20, 2014, 02:25:07 AM »

Device Problem No Known Device Problem
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
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. 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 #3007566237-2009-09298.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564556
« Last Edit: November 08, 2014, 04:41:33 AM by dennis100 » Logged
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« Reply #93 on: January 20, 2014, 03:24:56 AM »

Device Problems Device remains implanted; Implant, reprogramming of
Event Date 05/31/2009
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Manufacturer Narrative
See scanned pages.

 
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
« Last Edit: November 08, 2014, 04:42:01 AM by dennis100 » Logged
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« Reply #94 on: January 22, 2014, 09:23:49 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
« Last Edit: November 08, 2014, 04:49:30 AM by dennis100 » Logged
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« Reply #95 on: January 26, 2014, 03:00:07 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: November 08, 2014, 04:43:29 AM by dennis100 » Logged
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« Reply #96 on: January 28, 2014, 04:47:34 AM »

Model Number 37601
Event Date 09/20/2013
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was reported that the patient had undergone bilateral implants on (b)(6) 2013. It was noted that since the brain operation the patient had exhibited some periods of confusion and even psychosis. It was noted that the patient was admitted to the hospital for a week after the surgery and recently had been in a long term rehab center. The healthcare professional was treating symptoms with anti-psychotic medication but the patient had little improvement. Patient¿s stimulation was activated bilaterally and resulted in parkinson¿s symptoms improvement. It was further noted that at the time of this report the left brain lead was turned off due to it causing some dysarthria. The patient¿s stage 2 surgery had been done on (b)(6) 2013. Additional information 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=3499564
« Last Edit: November 08, 2014, 04:43:49 AM by dennis100 » Logged
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« Reply #97 on: January 28, 2014, 09:43:31 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/04/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
(b)(4).

 
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: November 08, 2014, 04:44:13 AM by dennis100 » Logged
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« Reply #98 on: January 28, 2014, 09:44:48 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/27/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: denys d, mantione m, figee m, et al. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch gen psychiatry. Oct 2010;67(10): 1061-1068. Summary: the authors conducted a double-blind, sham-controlled trial to demonstrate that bilateral stimulation of the nucleus accumbens can be an effective and safe treatment in treatment-refractory pts with obsessive compulsive disorder (ocd). All pts underwent electrode implantation in the same target area, and stimulation settings were applied uniformity throughout the study. During the treatment period of 21 months, obsessive-compulsive symptoms decreased by 52%, and 9 of 16 pts responded, with a mean improvement of 72%. Anxiety and depressive symptoms decreased by half. The surgical procedure and stimulation were well tolerated. Permanent adverse events were limited to mild forgetfulness and word-finding problems. Increased libido was reported by several pts but may be interpreted as a return to normal functioning rather than an adverse event. Reportable event: one pt, ((b)(6) female), experienced a wound infection and numbness at the incision site. This pt also experienced tiredness, paresthesias in the hands and feet and hypomanic symptoms. The hypomania or elevated mood occurred shortly after the switch of the contact points from 0 or 1 to 2 or 3 and lasted for 2 days. Elevated mood or hypomania never required the addition of a mood stabilizer, and the adverse event was rated as mild. Elevated mood was frequently reported during reactivation of the stimulation after an off period. For this pt, the effect of stimulation was not subjectively noticeable. See literature article with mfr report# 3007566237201010486.

 
Manufacturer Narrative
(b)(4) (paresthesias of the hands and feet). At this time no additional info was available, additional info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1939551
« Last Edit: November 08, 2014, 04:44:42 AM by dennis100 » Logged
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« Reply #99 on: February 07, 2014, 07:57:54 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/01/2013
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Claeys, i. , santens, p. , van den abbeele, d. , van roost, d. , lemmens, g. M. D. A manic episode after bilateral subthalamic stimulation in a patient with advanced parkinson's disease. Acta neuropsychiatrica. 2013;25(6):367-369. Doi: 10. 1017/neu. 2013. 30 summary: deep brain stimulation (dbs) has proven to be an effective treatment for patients with refractory symptoms in the advanced stages of parkinson¿s disease. However, different psychiatric and cognitive problems may occur after dbs. We report a case of a manic episode after dbs of the subthalamic nucleus in a patient with advanced parkinson¿s disease. After slow and gradually restart of the neurostimulation using the lowest effective intensity, the motor symptoms remained sufficiently under control without causing any psychiatric problems. Reported events: one (b)(6) old male patient with parkinson¿s disease was treated with deep brain stimulation (dbs) of the subthalamic nucleus (stn). The reporter stated that the patient¿s surgery had gone well and the patient¿s motor symptoms had markedly improved following stimulation at 2 volts. Four weeks after implant, the patient was reportedly urgently admitted to the hospital with important behavioral changes. It was noted that the patient was not able to sleep at night and only slept 1-2 hours during the daytime. The patient¿s mood was reportedly elevated and had logorrhea. The reporter stated that the patient¿s behavior was impulsive and disinhibited, as the patient was ¿buying lots of things¿ and ¿making inappropriate sexual comments. ¿ the reporter stated that the patient¿s psychomotor activity was increased and the patient was agitated. The patient also reportedly had grandiose ideas. The patient reportedly had no insight in the behavioral changes and felt ¿fantastic. ¿ it was noted that there were no hallucinations or suicidal ideas present. It was reported that following the initial discharge from the hospital, the patient had only slept for four hours per night and his mood was ¿a bit elevated but not problematic. ¿ it was noted that this was initially ascribed to the patient¿s feelings of relief after the surgical procedure. The reporter stated that the patient was diagnosed with a manic episode ¿probably elicited by dbs. ¿ the dbs was then turned off and the patient¿s motor symptoms, including rigidity and camptocormia rapidly re-appeared but all behavioral changes disappeared. The reporter stated that dbs was again initiated and gradually but more slowly increased to 1. 5 volts bilaterally. The reporter stated that this stimulation sufficiently controlled the motor symptoms without causing any behavioral problems and any need for further anti parkinson medication. It was noted that the patient was given 100mg daily trazodone for sleep difficulties. 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=3585639
« Last Edit: November 08, 2014, 04:45:09 AM by dennis100 » Logged
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« Reply #100 on: March 28, 2014, 12:23:03 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening
Manufacturer Narrative
Product id: 3387s-40, lot# va05qgb, implanted: (b)(6) 2013, product type: lead. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer. Patient product id: 3387s-40, lot# va074jr, implanted: (b)(6) 2013, product type: lead. (b)(4).

 
Manufacturer Narrative
(b)(4).

 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported the patient had an altered mental status, specifically a manic episode. It was reported that there were no alleged product issues, no troubleshooting was performed, and no action was required as a result of the event. It was reported the patient¿s status was unable to be obtained at time of this report. Additional information received reported that hospitalization was required as a result of the event. The patient outcome was serious life-threatening illness/injury recovered without sequelae. The symptoms associated with the reported event included mania. The cause of the event was unknown. It was unknown if the event was due to the implantable neurostimulator (ins) or the lead/extension. It was noted that next to reprogramming ¿device turned off¿ was written.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3622600
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« Reply #101 on: March 28, 2014, 12:23:33 PM »

Model Number 37603
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported after the patient was implanted they felt shaking, they were depressed and mentally out of it and they hallucinated. It was noted, the patient was not programmed until a few weeks after the implant but the patient indicated that the unit¿s stimulation coupled with the medication contributed to it. It was noted, the patient was in withdrawal because too much of their medication was ¿taken away. ¿ it was stated this occurred one year prior to report. It was stated their doctor was in the process of adjusting their medication. It was noted, the patient had essential tremor and parkinson¿s disease tremors but their doctor chose ¿to go after to parkinson¿s disease tremors. ¿ it was noted they did not want to treat the essential tremor due to the patient¿s age and their health.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3628613
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« Reply #102 on: April 10, 2014, 09:47:43 PM »

Model Number NEU_INS_STIMULATOR
Event Date 12/14/2013
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id 3389, lot # unknown, product type lead; product id 3389, lot # unknown, product type lead; product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator; product id 3389, lot # unknown, product type lead; product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator; product id 3389, lot # unknown, product type lead; product id neu_unknown_ext, lot # unknown, product type extension. (b)(4).

 
Event Description
Carlson, j. D. , neumiller, j. J. , swain, l. D. , mark, j. , mcleod, p. , hirschauer, j. Postoperative delirium in parkinson's disease patients following deep brain stimulation surgery. Journal of clinical neuroscience : official journal of the neurosurgical society of australasia. 2014:doi 10. http://Http://dx. Doi. Org/10. 1016/j. Jocn. 2013. 12. 007. Summary: deep brain stimulation (dbs) surgery is an effective treatment for patients with advanced parkinson¿s disease. Delirium in hospitalized parkinson¿s disease patients is common and often leads to prolonged hospital stays. This study reports on the incidence and etiology of postoperative delirium following dbs surgery. Patients (n = 59) with advanced parkinson¿s disease underwent bilateral (n = 56) or unilateral (n = 3) dbs electrode implant surgery, followed 1 week later with surgical placement of dbs generators. The development of delirium during either hospital stay was evaluated retrospectively from the hospital chart. Potential causes of delirium were evaluated, including history of delirium, opiate equivalents, medication administration delays and missed doses during hospitalization, and parkinson¿s disease duration. Delirium following implantation of dbs electrodes was common (22% of patients). It was less commonly associated with generator placement (10%). A history of delirium, age, and disease duration were positive predictors of delirium. Opiate equivalent doses were negatively correlated with delirium. Missed parkinson¿s medication doses (53% of patients) and delayed administration (81% of patients) were common, and had a slight relation with delirium. Delirium was not related to complexity of medication regimen or use of dementia medications. Despite the presence of delirium most patients still only required a single night in the hospital post-surgery (67%). Prolonged hospital stay was due not only to delirium but also severe off states and other medical issues. Recognition and expectant management of delirium is best accomplished in a multidisciplinary setting, including the patient¿s family and nursing, pharmacy and neurological surgery staff. Reported events: 7 parkinson¿s disease (pd) patients had a prolonged hospital stay following deep brain stimulation (dbs) lead implant due to pd related uncontrolled delirium. It was noted that delirium was broadly defined as the occurrence of any event of hallucinations, delusions, or disorientation to circumstance, even if apparently benign. It was noted that preoperative hallucinations were present in an unknown number of the patients. The reporter stated that the surgical implantation of the electrodes likely had a direct psychotropic effect in contrast to other non-intracranial surgeries in parkinson¿s disease. The reporter stated that the delirium following dbs surgery cleared quickly in all patients and there was no apparent long term induction of sustained delirium. Four parkinson¿s disease (pd) patients had a prolonged hospital stay following deep brain stimulation (dbs) implantable neurostimulator (ins) implant due to uncontrolled delirium. It was noted that delirium was broadly defined as the occurrence of any event of hallucinations, delusions, or disorientation to circumstance, even if apparently benign. It was noted that preoperative hallucinations were present in an unknown number of patients. The reporter stated that the delirium following dbs surgery cleared quickly in all patients and there was no apparent long term induction of sustained delirium. Five parkinson¿s disease (pd)patients had a prolonged hospital stay following deep brain stimulation (dbs) lead implant due to medical conditions such as hypertension, pneumonia, or nausea. Two parkinson¿s disease (pd) patients had a prolonged hospital stay following deep brain stimulation (dbs) implantable neurostimulator (ins) implant due to medical issues. Five parkinson¿s disease (pd) patients had a prolonged hospital stay following deep brain stimulation (dbs) lead implant due to pd related severe off states. One parkinson¿s disease (pd) patient had a prolonged hospital stay following deep brain stimulation (dbs) implantable neurostimulator (ins) implant due to a severe off state. 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=3704624
« Last Edit: November 08, 2014, 04:46:38 AM by dennis100 » Logged
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« Reply #103 on: May 11, 2014, 09:48:21 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported the patient had stimulation in the wrong location. It was noted the patient had a magnetic resonance image (mri) of the head on the day of report due to lead placement. It was stated the right implantable neurostimulator¿s (ins) left lead implant had not been turned on for some time and the duration was unknown. It was noted it ¿made them crazy. ¿ it was stated the settings were too high and the doctor wanted to remove the wire and put another one in. It was noted the lead was implanted in the wrong location of the brain. It was stated they had not interrogated or checked the impedances on that side at the time of report. It was noted the patient also had an x-ray to confirm that the wires did not cross over the chest area. Additional information received reported the ¿lead had never worked from the beginning. ¿ it was stated there was no problem with the impedance measurements. It was noted the patient had used the lead sometimes but not for long. It was noted the patient had good control of their tremor from the right lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3739542
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« Reply #104 on: June 08, 2014, 01:53:42 PM »

Model Number 7428
Event Date 10/27/2011
Event Type Injury Patient Outcome Hospitalization,Other
Event Description
It was reported on (b)(4) 2014 that immediately after implant, the patient experienced erratic blood pressure and delirium. The patient had to be admitted to physical rehab and had to wear a ¿hospital-bed alarm¿ and was eventually ¿strapped to the bed. ¿ the reporter stated that the patient¿s wife reported these issues to the hospital at the time. The reporter stated that the doctor seemed to dismiss the wife¿s claims, but it was only ¿second-hand info. ¿ additional information was requested, but was not available as of the date of this report.
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v814474, implanted: (b)(6) 2011, product type lead; product id 3387s-40, lot # v814474, implanted: (b)(6) 2011, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2011, product type extension. The initial reporter was the patient's wife, but no name or information was provided. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813619
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« Reply #105 on: July 04, 2014, 08:58:02 PM »

Model Number 37601
Event Date 07/19/2012
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot# va0074j, implanted: (b)(6) 2012, product type lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type extension; product id 37642, serial# (b)(4), implanted: (b)(6) 2012, product type programmer, patient; product id 3389s-40, lot# va0074j, implanted: (b)(6) 2012, product type lead. (b)(4).
Event Description
It was reported that the patient stayed in the hospital 2 extra days after his surgery on (b)(6) 2012 due to dementia like symptoms from stress after the surgery. It was noted that the outcome was resolved without sequelae on (b)(6) 2012. It was noted that the etiology was ¿surgery/anesthesia. ¿ it was noted that the event was not related to the device or therapy and not related to the implant procedure. It was noted that signs and symptoms included dementia like symptoms. It was noted that the event resulted in prolonged existing hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854316
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« Reply #106 on: September 06, 2014, 06:16:59 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury Patient Outcome Other
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 individual patient information and additional information regarding the reported event. Concomitant medical products: product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).
Event Description
Amami, p. , dekker, i. , piacentini, s. , ferré, f. , romito, l. M. , franzini, a. , foncke, e. M. J. , albanese, a. Impulse control behaviours in patients with parkinson's disease after subthalamic deep brain stimulation: de novo cases and 3-year follow-up. Journal of neurology, neurosurgery, and psychiatry. 2014;0:1-3. Doi: 10. 1136/jnnp-2013-307214. Summary: to document the occurrence of impulse control behaviours (icbs) in patients with parkinson¿s disease after 3 years of continuous deep brain stimulation (dbs) of the subthalamic nucleus (stn). Detailed neurological and icb assessments were performed before stn dbs and up to 3 years after implant. Thirteen out of 56 patients (23. 2%) had icbs at baseline; they took higher doses of dopamine agonists (daa). Three years after implant 11 had fully remitted with a 60. 8% reduction of daa medication; the remaining two, who had a similar medication reduction, had only compulsive eating, having recovered from hypersexuality. Six of the 43 patients without icbs at baseline (14%) developed transient de novo icbs after implant; none of them had icbs at the 3-year observation. Icbs were abolished in patients 3 years after stn dbs and daa dosages were lowered. New icbs may occur after implant and are transient in most cases. Compulsive eating may be specifically related to stn stimulation. Reported event: 2 patients developed dementia. The source literature did not include specific device information. 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=4025131
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« Reply #107 on: October 12, 2014, 03:02:17 AM »

Model Number 37602
Event Date 08/23/2014
Event Type Injury
Event Description
It was reported that the patient¿s deep brain stimulator (dbs) batteries were replaced 5 days prior to report due to normal elective replacement indicator (eri). Two days prior to report, the patient had been admitted to the hospital due to agitation and confusion. The patient was put on iv ativan to reduce agitation. Agitation thought to be due to the effect of anesthesia and patient¿s increased dementia. A ct scan was done and the patient did not have any signs of cerebral infarction but did have significant atrophy on the left side of the brain. The patient developed congestive heart failure and passed away the day of the report. It was indicated that it felt that this was a natural transition as he had continued health issues and had a mental decline. It was noted that the dbs system had allowed the patient to keep active for several years. The patient developed rheumatoid arthritis, cardiac issues, diabetes, and dementia. The death was not seen to involve the dbs units or replacement.

Manufacturer Narrative
Product id: 37602, serial# (b)(4), product type: implantable neurostimulator. Product id: 37602, serial# (b)(4), 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_unknown_ext, serial# unknown, product type: extension. Product id: neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4104182
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« Reply #108 on: November 08, 2014, 04:48:32 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# v100746, implanted: 2008 (b)(6); product type lead product id 7436, serial# (b)(4), implanted: 2008 (b)(6); product type programmer, patient product id 3387s-40, lot# v100746, implanted: 2008 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2008 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2008 (b)(6); product type extension. (b)(4).

Event Description
It was reported, the patient needed an mri of their brain. The patient had altered mental status and was ¿acting crazy. ¿ they were not sure what was wrong or what the reason for the mri was. They started to have the issues on 2014 (b)(6) and they already had a ct scan. It was later reported that the mri was related to implant. The patient had had a change in personality since (b)(6) prior to the date of this report and they were wanting to look at a potential abscess around the system. The device is off. No outcome was provided regarding the event. 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=4153242
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« Reply #109 on: December 05, 2014, 09:01:42 AM »

Model Number 37601
Event Type Injury
Event Description
Quinn, d. K. , rees, c. , brodsky, a. , deligtisch, a. , evans, d. , khafaja, m. , abbott, c. C. Catatonia after deep brain stimulation successfully treated with lorazepam and right unilateral electroconvulsive therapy: a case report. The journal of ect. 2014;30(3):e13-15. Doi: 10. 1097/yct. 0b013e31829e0afa summary: the presence of a deep brain stimulator (dbs) in a patient who develops neuropsychiatric symptoms poses unique diagnostic challenges and questions for the treating psychiatrist. Catatonia has been described only once, during dbs implantation, but has not been reported in a successfully implanted dbs patient. We present a case of a patient with bipolar disorder and renal transplant who developed catatonia after dbs for essential tremor. The patient was successfully treated for catatonia with lorazepam and electroconvulsive therapy after careful diagnostic workup. Electroconvulsive therapy has been successfully used with dbs in a handful of cases, and certain precautions may help reduce potential risk. Catatonia is a rare occurrence after dbs but when present may be safely treated with standard therapies such as lorazepam and electroconvulsive therapy. Reported events: one 67-year-old female patient with a history of bipolar disorder and renal transplant was implanted with deep brain stimulation (dbs) to treat essential tremor in may 2012. The patient reportedly had significant improvement in tremor without complication. However, beginning in september 2012, the patient experienced worsening depressive symptoms of low mood, psychomotor retardation, decreased appetite, decreased energy, and hopelessness. At the time, the patient was prescribed duloxetine 30 mg daily, escitalopram 20 mg daily, and quetiapine 25 mg nightly. The patient was switched from duloxetine to mirtazapine 15 mg daily without benefit. On december 19, the patient¿s depressive symptoms became so severe that she was admitted to the local psychiatry ward for inpatient treatment of severe depression with grave passive neglect. During the initial assessment, her depressive symptoms continued to worsen, until she was noted on her seventh hospital day to be mute, stuporous, withdrawn, and negativistic. She did not follow one-step commands and refused oral medications and nourishment by mouth. The patient was then transferred to a general medical floor when her creatinine increased 1. 9 mg/dl, prompting concerns of acute kidney injury and renal transplant rejection. The patient was stabilized with intravenous fluids and tube feeds via nasogastric tube and continued to manifest intermittent catatonic symptoms as above. Laboratory values at that time were notable for normal chemistries and complete blood count. Her liver function tests demonstrated elevated alkaline phosphatase of 900 u/l but were otherwise normal; tacrolimus level was mildly subtherapeutic at 4. 0. An electroencephalogram (eeg) showed a posterior dominant awake alpha rhythm with intermittent theta waves. Computed tomography (ct) scan of the head demonstrated dbs electrode in place and mild cerebral atrophy. B12, folate, and thyroid-stimulating hormone were within reference ranges, and treponema pallidum antibodies were negative. Her dbs device was turned off with no subsequent change in her mood or catatonic symptoms. Her psychiatric medications were continued via nasogastric tube, and methylphenidate 10 mg twice daily (bid) and dronabinol 2. 5 mg bid were added for energy and appetite stimulation without effect. Lorazeopam challenge with 2 mg intravenously administered brought about rapid improvement in stupor and mutism within 30 minutes; the patient began speaking, interacting, and feeding herself again. Lorazepam 2 mg three times daily (tid) was instituted, but significant sedation on this regimen led to transfer to a geriatric psychiatry ward at a tertiary care center for consideration of electroconvulsive therapy (ect). At the geriatric psychiatry ward, c oncern for risk of harm to the patient from ect with dbs in place prompted further medication trials: all psychotropics werediscontinued, and methylphenidate 10 mg bid and dronabinol 2. 5 mg bid were restarted. Her bush-francis catatonia rating scale score was 9 (3 for mutism, 3 for stupor, 3 for withdrawal). On the fifth hospital day, the patient experienced a witnessed generalized tonic-clonic seizure and was admitted to the neurology service. An exhaustive workup for organic causes of seizures and catatonia in an immunosuppressed patient, including serum electrolytes, complete with blood count, chest radiograph, ceruloplasmin, vitamin b levels, antinuclear antibody, c-reactive protein, erythrocyte sedimentation rate ammonia, hiv, hepatitis panel, serum lactate, lumbar puncture with viral and bacterial assays, cytology, oligoclonal bands, cell count, total protein and glucose, 14-3-3 protein, paraneoplastic antibody panel, parathyroid hormone levels, and ct scan of the brain/chest/abdomen/pelvis, was unrevealing. Magnetic resonance imaging (mri) of the brain was not obtained because of the presence of the dbs. Electroencephalogram initially showed right-sided slowing but on repeat testing was without abnormality. Urinalysis detected a urinary tract infection, and this was treated without change in condition. Alkaline phosphatase was elevated between 300 and 1000 u/l, thought to be due to medication effect and renal insufficiency. Quantiferon test for tuberculosis was positive, but induced sputum cultures were negative. Renal transplantation consultation concluded that the patient¿s tacrolimus was not the cause of the current catatonic symptoms as it had been tolerated well at the current dose for years; there had been no supratherpeutic levels recently, and there were no other symptoms of tacrolimus toxicity such a s tremor or headache. The patient worsened during the first week on the neurology service, becoming completely mute, stuporous, and withdrawn, with sinus tachycardia. Percutaneous gastric tube was placed, and tube feeds were intitiated. Methylphenidate and dronabinol were discontinued. Rechallenge with lorazepam 2 mg intravenously administered brought about immediate improvement in catatonic symptoms, and the patient was interactive but sedated on 1. 5 mg bid, with poor oral intake, psychomotor retardation, low energy, and depressed mood. When no etiology for her seizure besides medications (stimulant toxicity or benzodiazepine withdrawal) was found, the patient was transferred back to the geriatric unit for definitive treatment of catatonic depression with ect. Precautions taken before the first session included ensuring dbs was off with voltage set at zero; consultation with neurology, manufacturing representative, and high-volume ect and dbs centers for second opinions; pre- and post-ect imaging to ensure lead placement; and palpation of the implanted pulse generator (ipg) cable, and electrode cap before each session. Right unilateral electrode placement was chosen to allow the greatest distance between the ect electrodes and the left frontal dbs hardware. Induction and modification were achieved with methohexital 50 mg and succinylcholine 50 mg before each treatment. Seizure lengths ranged from 21 to 112 seconds. The patient received 12 treatments of the right unilateral ultrabrief-pulse ect with a thymatron system iv without complication. She started to show clinical improvement after the second treatment, as evidenced by increased oral intake, spontaneous speech, and activity levels. Escitalopram was discontinued, and lamotrigine 25 mg daily and aripiprazole 5 mg daily were added to her medication regimen for mood stabilization when she began to display a more labile affect and loose associations around the fourth ect treatment. By the 10th ect treatment, she was ambulating, eating, taking medications independently, and coming out of her room to socialize in the milieu. Mood was euthymic, and bush-francis catatonia rating scale score was 0. She was discharged to home, and the ect service recommended continuation ect at tapering frequencies, which she tolerated without complication. Of note, the patient¿s tremor was noticeably improved after ect with dbs device still off. The reporter stated that upon the patient¿s admission, the dbs was interrogated with no evidence of malfunction of the ipg or hardware. It was also noted that turning off the device and allowing for ¿washout¿ of stimulation effect for over four weeks did not yield any improvement in the patient¿s catatonic depression. The reporter stated that the patient¿s one-time generalized tonic-clonic seizure was most likely a result of stimulant toxicity and benzodiazepine withdrawal and not related to the dbs or a seizure disorder. The source literature included the following device specifics: implantable neurostimulator activa pc-b model 37601 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=4270589
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« Reply #110 on: December 05, 2014, 09:02:15 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# v280392, implanted: 2009 (b)(6); product type lead product id 3387s-40, lot# v250513, implanted: 2009 (b)(6); product type lead product id 37085-60, serial# (b)(4), implanted: 2009 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2009 (b)(6); product type extension. (b)(4).

Event Description
It was reported that in august, the patient had a dementia incident and they had to go to the hospital where they went into parkinson¿s crisis. The reporter stated that they thought the patient was not taking their medication. The implantable neurostimulator (ins) was found to be dead and the patient had to be put on a ventilator. The ins was replaced due to reaching end of life (eol). A manufacturing representative thought the ins was at normal eol due to the patient¿s high settings, but they were not sure. 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=4269437
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« Reply #111 on: December 05, 2014, 09:28:27 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that following implant the patient was more emotional and had mental issues. The patient stated that it was mentally the hardest thing they ever did. The patient was in a wheelchair prior to implant and they were not out of the wheelchair. There was a problem with the electrode or lead not working that resulted in a subsequent surgery. During the surgery the patient¿s healthcare professional (hcp) tried to pull the lead, but the lead was calcified to the brain so the patient was left with one led not working. 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.

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« Reply #112 on: January 10, 2015, 12:55:23 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
This value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. 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 individual patient information and additional information regarding the reported events. Concomitant: product id 3389, lot# unknown, product type lead. Product id 7428, product type implantable neurostimulator. Product id 7428, product type implantable neurostimulator. Product id 7428, product type implantable neurostimulator. Product id 3389, product type lead. Product id 7428, product type implantable neurostimulator. (b)(4).

Event Description
Chiou, s. M. , lin, y. C. , lu, m. K. , tsai, c. H. Bilateral subthalamic stimulation for advanced parkinson disease: early experience at an eastern center. Neurological sciences : official journal of the italian neurological society and of the italian society of clinical neurophysiology. 2014. Doi 10. 1007/s10072-014-2008-x summary: deep brain stimulation (dbs) of the subthalamic nucleus (stn) can improve the life quality of patients with advanced parkinson disease (pd). However, previous studies have stemmed mainly from (b)(6). Present study analyzed the 6-month outcomes of bilateral stn-dbs therapy that were observed during a 9-year period at a (b)(6). We retrospectively reviewed 72 consecutive patients, whose mean disease history was 8 years when they underwent surgery. The median ¿¿drug-off¿¿ hoehn and yahr stage was 3. The stn was targeted using t2-weighted magnetic resonance imaging and electrophysiological guidance. The over-time mean differences in the unified pd rating scale (updrs) scores and daily levodopa-equivalent dose (led) were assessed using the repeated measurements anova at 3 and 6 months relative to those of presurgical drug-off baseline. At 6 months postsurgery, the mean updrs total, part ii and part iii subscores significantly decreased by 27, 30 and 25 %, respectively, with clinically high effect size. Tremors were markedly (66 %) ameliorated. Moreover, problems of akinesia, rigidity, and locomotion were significantly improved by 20 %. The mean daily led needs decreased by 25 %; thus, drug-induced dyskinesia was markedly (80 %) diminished. Stn-dbs therapy could provide similarly effective impacts to eastern and western pd patients. Preoperative optimal selection of patients and postoperative delicate programming ensure a better surgical improvement. Reported events: two patient with deep brain stimulation (dbs) for parkinson¿s disease experienced a seizure the day after implantation. It was noted that the patient subsequently exhibited a smooth treatment course. Two patients with dbs for parkinson¿s disease had malpositioned right leads, which were relocated when the implantable neurostimulator (ins) was implanted. It was noted that the patients subsequently exhibited a smooth treatment course. Two patients with deep brain stimulation (dbs) for parkinson¿s disease experienced acute psychosis for 3-4 days. It was noted that the patients subsequently exhibited a smooth treatment course. One diabetic patient with dbs for parkinson¿s disease experienced fluid accumulation in the chest ins pocket within one week; therefore, the ins was removed immediately and re-implanted four months later. It was noted that the patient subsequently exhibited a smooth treatment course. The source literature included the following device specifics: lead model 3389 and kinetra ins model 7428 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=4376136
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« Reply #113 on: January 10, 2015, 12:57:12 AM »

Model Number 37601
Event Date 07/03/2013
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va097p0, implanted: (b)(4) 2013, product type: lead. Product id: 3387s-40, lot# va097p0, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial#: njz143041n, 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. (b)(4).

Event Description
It was reported the patient had manic episodes with the deep brain stimulator (dbs) therapy. The patient had a history of substance abuse prior to the dbs therapy. They did not have a history of manic episodes prior to dbs therapy. They were programmed a few times after implant and they took mirapex as well when they developed the manic episodes. The patient was hospitalized due to mania and at that time, the mirapex was stopped and the dbs was turned off. At that time, the stimulator had been off for a year. They had an appointment to be seen within the next week by their doctor to try programming the dbs again. The patient turned their stimulator back on the day prior to report for about 4 hours. Their daughter discovered that and then turned the dbs off. It was thought the patient had another manic episode as the patient left home during the night and hadn¿t been found yet. He had also displayed hypersexual and aggressive behavior in the past towards others that appeared to be related to having the dbs on. The patient had control over their voltage. They thought the patient had some benefit from the dbs and they thought he walked better, had less stiffness and less tremor, but they still had some falls. Additional information received reported the patient had been found by the police department and was admitted to the hospital. The daughter had thought that she had turned off the device the night before but when the device was checked, it was still on. The device was successfully turned off. The physician did not think that the patient was a good candidate for having dbs so they were going to leave the device turned off. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information.

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« Reply #114 on: January 10, 2015, 08:26:06 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0313854v, implanted: (b)(6) 2003, product type: lead. 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: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387-40, lot# j0313854v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported the patient started having symptoms of dementia in (b)(6)¿ (b)(6) and the patient had two seizures in february that accelerated the dementia. The patient recently saw a healthcare professional (hcp), but they do not work with deep brain stimulation therapy. 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=4300829
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« Reply #115 on: March 06, 2015, 12:57:29 PM »

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).

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« Reply #116 on: March 07, 2015, 01:05:58 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had yet to find a neurologist to make the therapy work. The patient was suffering from psychosis, specifically hallucinations and paranoia, and was in a psych hospital at the time of the report. The reporter was not sure if this was related to the implantable neurostimulator (ins), but it started about a year after implant. The reporter had been talking to the psychiatrist about if it was a combination of the patient¿s medication and the stimulation; the reporter had read online where someone had to adjust the medication and therapy to remedy this issue. The reporter intended to get the psychiatrist and neurologist together to discuss the patient¿s therapy. No patient outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 37092, lot# 254130001, implanted: (b)(6) 2010, product type: accessory; 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; product id 3387s-40, lot# v526048, implanted: (b)(6) 2010, product type: lead; product id 3387s-40, lot# v508855, implanted: (b)(6) 2010, product type: lead. (b)(4).

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« Reply #117 on: March 07, 2015, 01:06:56 AM »

Model Number NEU_INS_STIMULATOR
Event Type Death
Manufacturer Narrative
Date of death: please note the patient's date of death was unavailable at the time of report. The date reported reflects the date the attached literature article was published online. Other: psychosis. 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 individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

Event Description
Thavanesan, n. , gillies, m. , farrell, m. , green, a. L. , aziz, t. Deep brain stimulation in multiple system atrophy mimicking idiopathic parkinson's disease. Case reports in neurology. 2014;6(3):232-237. Doi: 10. 1159/000368571. Summary: deep brain stimulation (dbs) is approved for idiopathic parkinson¿s disease (ipd) but has a poor evidence base in parkinson-plus syndromes such as multiple system atrophy (msa). We describe the clinical and neuropathological findings in a man who was initially diagnosed with ipd, in whom dbs was unsuccessful, and in whom msa was unexpectedly diagnosed at a subsequent autopsy. This case report highlights that dbs is often unsuccessful in msa and also demonstrates that msa can masquerade as ipd, which may explain treatment failure in a small group of patients apparently suffering from parkinson¿s disease. Additionally, it also presents a case with an unusually long duration of disease prior to death, comparable only to a handful of other cases in the literature. Reported event: one (b)(6) male patient underwent 2-stage bilateral deep brain stimulation (dbs) implant for parkinson¿s disease in (b)(6) 2008. Stage 1 initially gave positive results barring an episode of confusion, hypotension and reduced glasgow coma scale (gcs) score attributed to overstimulation. Titration was effective, and the patient was switched from regular madopar to prn. Stage 2 was complication free aside from transient calibration paresthesia. Medications were stopped two days postoperatively with good gait, no tremor, no freezing and improved left arm mobility. A health care provider (hcp) and the patient specifically reported improvement in rigidity and gait. The patient was discharged three days later. The patient subsequently deteriorated after two weeks, returning to pre-operative medication doses, with his symptoms worse than preoperatively. The patient experienced confusion, short-term memory impairment and hypertonia in the left arm. Subsequent titration helped minimally. In the subsequent four years until time of death, the patient developed episodes of psychosis, dopamine dysregulation syndrome, iga nephropathy, chronic renal failure and ultimately terminal clostridium difficile colitis. Neuropathological examination, performed six years after surgery during the patient¿s autopsy, confirmed the placement of dbs electrodes in the subthalamic nucleus (stn). The neuropathological findings were those of multiple system atrophy (msa). The pathological diagnosis was based on extensive striatal and subcortical white matter accumulation of ¿-synuclein coupled with profound depletion of the neurons from the striatum and substantia nigra with atrophy and gliosis. Oligodendroglial ¿-synuclein inclusions were also very extensive in cerebral and cerebellar white matter, and the middle cerebellar peduncle also showed prominent ¿-synuclein-positive glial inclusions indicating elements of both a striatonigral and olivopontocerebellar pattern of distribution. Noteworthy was the finding of prominent ¿-synuclein-positive glial inclusions adjacent to the dbs insertion site in the stn. It was noted that incorrect preoperative idiopathic parkinson¿s disease diagnose showed positive initial response to surgery followed by rapid decline secondary to progression of msa and subsequent death. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4521234
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« Reply #118 on: April 19, 2015, 09:41:35 AM »

Model Number 37601
Event Date 06/17/2013
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 3387, lot # unknown, product type lead; product id neu_unknown_ext, lot # unknown, product type extension. (b)(4).

Event Description
It was reported that the patient experienced visual and auditory hallucinations. No corrective actions were taken. The visual and auditory hallucinations were noted as resolved. The patient also experienced paranoid delusions. No corrective actions were taken. The paranoid delusions were not resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4642064
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« Reply #119 on: May 09, 2015, 02:13:57 AM »

Model Number 37601
Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension. (b)(4).

Event Description
It was reported that the patient experienced altered mental status. Corrective actions included new hospitalization. The patient was found by a study partner confused and unresponsive in the bathroom and was transferred via emt to the er. A full workup indicated that the subject was bradycardic and confused, ct head, ua, blood work was all negative. The study partner realized that the patient had ingested the study partners medications included zolpidem 10 mg, clonazepam 1mg, aspirin 81mg, simvastatin 20mg and tamsulosin. The patient was discharged from the er later that day alert, oriented with no neurological deficit. The temporarily altered mental status was attributed to the medication and had resolved with no recurrence. The event was closed. The patient experienced a mild uti. Corrective action included medication added, discontinued or dose change. The medication was rocephin 1g. The mild uti was considered open.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4649154
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« Reply #120 on: May 09, 2015, 02:14:40 AM »

Model Number 37601
Event Date 01/24/2013
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3387, lot# unknown, product type: lead. Product id: 3387. Lot# unknown, product type: lead. Product id: neu_unknown_ext, lot# serial# unknown, product type: extension. Product id: neu_unknown_ext, lot# serial# unknown, product type: extension. (b)(4).

Event Description
It was reported the patient had perioperative delirium. The suspected cause was noted as the implant/study. There was no corrective action taken and the event resolved on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4653387
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« Reply #121 on: May 09, 2015, 02:15:25 AM »

Model Number 37601
Event Date 03/06/2013
Event Type Injury
Event Description
It was reported the patient had experiential phenomenon, depression, and illusions. No intervention was taken and the event was considered resolved.

Manufacturer Narrative
Concomitant products: product id 3387, lot # unknown, product type lead; product id 3387, lot # unknown, product type lead; product id neu_unknown_ext, serial # unknown, product type extension; product id neu_unknown_ext, serial # unknown, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4658177
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« Reply #122 on: May 09, 2015, 02:16:09 AM »

Model Number 37602
Event Date 03/17/2015
Event Type Injury
Event Description
It was reported the patient was admitted to this hospital for a mental change and a kidney infection. The patient¿s healthcare professional (hcp) wanted a manufacturing representative to check to make sure the device was still functioning properly. The implantable neurostimulator (ins) was programmed on the left to 0-, 3+ at 4. 8v, 60 us, and 160 hz. Therapy impedance on the left side was measured to be 2638 ohms. Impedances on the left side, run at 1. 5v, were measured to be high with impedance of 2773 ohms being measured on electrode pair c-0. The left ins battery voltage was measured to be 2. 98v. The right ins was programmed to 1-, 3+ at 4. 5v, 60 us, and 180 hz. Therapy impedance on the right side was measured to be 2538 ohms. Impedances on the right side, run at 3v, were measured to be high on electrodes c-0, c-3, and 0-3. The right ins battery voltage was measured to be 2. 87v. 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: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389-40, lot# j0406024v, implanted: (b)(6) 2004, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4664551
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« Reply #123 on: May 09, 2015, 02:16:45 AM »

Model Number 37601
Event Date 08/15/2013
Event Type Injury
Event Description
It was reported that the patient had delusions with jealousness. The patient had psychotic symptoms and was admitted to psychiatric hospital. The outcome was resolved with sequelae. Further follow up is being conducted, if additional information is received, a supplemental report will be submitted.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4712747
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« Reply #124 on: June 08, 2015, 07:00:31 AM »

Model Number 37601
Event Date 04/05/2015
Event Type Injury
Event Description
Additional information received reported that the patient experienced an intracranial infection in the right frontal lobe.

Manufacturer Narrative

Event Description
It was reported that there was intracranial infection. The patient presented to the er with altered mental status, severe head and neck pain, and feeling like his insides were melting. The patient experienced in-patient hospitalization and an emergency room visit. Other surgical intervention was conducted including complete removal of bilateral electrode systems and generator. Perioperative antibiotics were administered specifically kefzol. The patient did not have meningitis. An organism culture showed staphylococcus aureus from the wound. Medication were administered specifically iv vancomycin and iv nafcillin on (b)(6) 2015. The outcome was noted as resolved without sequelae.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# va0qxld, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 3387s-40, lot# va0nplb, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4760034
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« Reply #125 on: June 08, 2015, 07:01:11 AM »

Model Number 37601
Event Date 03/14/2015
Event Type Injury
Event Description
It was reported that the patient had acute delirium. Signs and symptoms included verbal agitation, confusion, encephalopathy and slight seizure activity. It was noted that the surgery/anesthesia was possibly related to the device or therapy and it was possibly related to implant procedure. The event had resulted in in-patient hospitalization and seizure medication. Lab work results were negative for an infection. Electroencephalogram (eeg) results indicated no seizure, no rhythmic or periodic patterns, intermittent bursts of generalized delta activity with slow posterior dominant rhythm (pdr). A computerized tomography (ct) scan without contrast results indicated edema in the superior right frontal lobe. The outcome was resolved without sequelae.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0q81g, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0q81g, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4). (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4771432
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« Reply #126 on: June 08, 2015, 07:01:57 AM »

Model Number NEU_INS_STIMULATOR
Event Date 02/13/2015
Event Type Injury
Event Description
Lilleeng, b. , gjerstad, m. , baardsen, r. , dalen, i. , larsen, j. P. The long-term development of non-motor problems after stn-dbs. Acta neurologica scandinavica. 2015 mar 6 2015: doi: 10. 1111/ane. 12391. Summary: stimulation of the subthalamic nucleus (stn-dbs) is an established treatment with long-term beneficial effects on motor sym ptoms in patients with parkinson¿s disease (pd). The long-term development of non-motor problems after stn-dbs is not fully understood. In this study, we have studied how non-motor problems develop in patients with and without stn-dbs. We collected data from a prospectively followed cohort of patients that had been operated with stn-dbs 6¿9 years before final examination and compared our findings to the longitudinal development of non-motor problems in a non-operated, comparable reference population. In general, the non-motor problems of advanced pd seem to develop independently of treatment with stndbs. We found that depressions do not worsen after stn-dbs, and the montgomery and aasberg depression rating scale score in operated patients was substantially reduced from pre-operatively to post-operatively. Further, fatigue may represent an important unrecognized side effect of long-term stimulation, as fatigue was found to increase rapidly in operated patients already a year after surgery and continued to increase trough the 6- to 9-year follow-up. The non-motor problems of advanced pd seem to develop independently of treatment with stn-dbs. This may influence the strategy for choice of when to perform this therapy for eligible patients. Reported events: 1. 8 patients with stn-dbs for parkinson¿s disease had hallucinations at last follow-up 6-9 years after surgery. 2. 2 patients with stn-dbs for parkinson¿s disease had hallucinations 1-1. 5 years after surgery. 3. 5 patients with subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease developed dementia at last visit 6-9 years after implant surgery according to the diagnostic and statistical manual of mental disorders, third edition, revised (dsm-iii-r) criteria. All five developed dementia between one year after surgery and final visit. It was noted that the mean mini-mental state examination (mmse) score was 23. 4 at last study visit. 4. 4 patients with subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease did not have functioning devices. 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
Age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. 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 individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4771898
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« Reply #127 on: June 08, 2015, 07:02:43 AM »

Model Number NEU_INS_STIMULATOR
Event Date 09/09/2013
Event Type Injury
Event Description
Chopra, a. , abulseoud, o. A. , sampson, s. , lee, k. H. , klassen, b. T. , fields, j. A. , matsumoto, j. Y. , adams, a. C. , stoppel, c. J. , geske, j. R. , frye, m. A. Mood stability in parkinson disease following deep brain stimulation: a 6-month prospective follow-up study. Psychosomatics. 2014;55(5):478-484. Summary: deep brain stimulation for parkinson disease has been associated with psychiatric adverse effects including anxiety, depression, mania, psychosis, and suicide. The purpose of this study was to evaluate the safety of deep brain stimulation in a large parkinson disease clinical practice. Patients approved for surgery by the (b)6) participated in a 6-month prospective naturalistic follow-up study. In addition to the unified parkinson's disease rating scale, stability and psychiatric safety were measured using the beck depression inventory, hamilton depression rating scale, and young mania rating scale. Outcomes were compared in patients with parkinson disease who had a psychiatric history to those with no co-morbid psychiatric history. The study was completed by 49 of 54 patients. Statistically significant 6-month baseline to end-point improvement was found in motor and mood scales. No significant differences were found in psychiatric outcomes based on the presence or absence of psychiatric comorbidity. Our study suggests that patients with parkinson disease who have a history of psychiatric co-morbidity can safely respond to deep brain stimulation with no greater risk of psychiatric adverse effect occurrence. A multidisciplinary team approach, including careful psychiatric screening ensuring mood stabilization and psychiatric follow-up, should be viewed as standard of care to optimize the psychiatric outcome in the course of deep brain stimulation treatment. Reported events: one patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced mania with psychotic features and required psychiatric hospitalization as a result. It was noted that the patient had no comorbidity prior to implant. 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. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4792212
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« Reply #128 on: June 08, 2015, 07:03:21 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension. (b)(4).

Event Description
It was reported that the patient had a change in mental status. The patient had gone crazy; patient was paranoid, acted schizophrenic, irrational, was jumping out of moving vehicles on the highway and was running around in traffic on the highway. Since march prior to the date of this report the patient had been in a psychiatric system 5 times without seeing a healthcare professional and had gone to another psych unit for a 4 day period which was the longest one and had not seen a healthcare professional. The patient was in jail at the time of this report as he had been deemed a danger to himself and others. The patient was currently on cinemas and had been previously been on forms of requip. Over time the patient had gone from 20mg to 3mg of medications due to the mental effects. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4805324
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« Reply #129 on: August 08, 2015, 09:46:58 AM »

Model Number 7428
Event Date 06/17/2015
Event Type Injury
Event Description
It was reported that 48 hours ago the patient was going through airport security and he passed through a medical detector. After passing through the patient sat near a security archway for about 15 minutes and then was required to pass through again. The patient was hospitalized, and had gone from a fully functional brain to now not able to hold a thought; he was unable to make a sentence and does not know where he is. The patient¿s wife described the patient¿s dementia as off the chart. The patient was incoherent and has been strapped down for safety. The patient¿s device was confirmed to be on, but the settings were unknown. Loss of therapy was reported. The patient¿s wife was trying to get a hold of the patient¿s implant doctor, but the doctor was currently away; she was going to try to get the patient transferred to his city. Follow up was performed but no additional information was available. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4900086
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« Reply #130 on: August 08, 2015, 09:47:36 AM »

Model Number 37601
Event Date 01/24/2013
Event Type Injury
Manufacturer Narrative
Product id 3708660, serial# (b)(4); product type extension product id 3387s-40, lot# va01k4q; product type lead product id neu_unknown_ext, serial# (b)(4); product type extension. (b)(4).

Event Description
It was reported, the patient experienced perio-operative delirium. The suspected cause was noted as implant/study. No corrective actions were taken and the patient¿s symptom resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4902069
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« Reply #131 on: August 08, 2015, 09:48:19 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that the deep brain stimulation (dbs) did not help the reporter's husband. It was a huge disappointment when the battery unit was turned on and nothing happened. It was a horrible month of healing from both surgeries and then nothing. The patient was still taking all medications and the tremors were horrible. The therapy had been a nightmare for the patient and his wife. The patient got delirium, as it was an extreme case. There was extreme pain during the surgery and also sleep deprivation. The first week after surgery, the patient's wife thought she was going to have to put him in a straight jacket. They were shown the miracle of what happens when the battery was turned on for other patients, however, this did not happen with the patient. The delirium went on for a solid week and the patient was never able to reduce their medication. On the day of the surgery the patient was taking 250 cd/ld every 2 hours and he was still taking that after the battery was turned on. The patient did walk better. His face still looked frozen but it was a little better. The patient was slow thinking, had no conversations anymore, and was a little pissy. The patient was always a super nice, kind guy but not after the surgery. The patient's wife was told, "it's brain surgery, he's gotta heal, etc. " but they did not tell her all the stuff that would happen. When asked a question, the patient would stare into space and not answer. The patient's wife was told that all the symptoms would be gone after six months and the programming would need to be fine tuned several times. She was also told that they never said the medication would be reduced and to give it a chance. The husband and wife left the neurologist's office two days prior to the report and going to the office did not work, which was shocking to them. They were telling people who called that it did not work. There was no change and it was very disappointing. No outcome or intervention 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.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4929592
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« Reply #132 on: September 07, 2015, 07:13:24 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator. Product id 3387-40, lot# j0322214v, implanted: (b)(6) 2003, product type: lead. Product id 748266, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 37642, serial# (b)(4), product type: programmer, patient. Product id 3387-40, lot# j0327188v, implanted: (b)(6) 2003, product type: lead. Product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 64002, lot# n274415, implanted: (b)(6) 2011, product type: adapter. Product id 37092, lot# 276480001, implanted: (b)(6) 2011, product type: accessory. (b)(4).

Event Description
The consumer reported that over the past five years the patient had experienced sudden "bouts" of dementia and that each time they experienced these symptoms they had been given antibiotics, which seemed to take care of the symptoms. The last time this happened, however, the antibiotics did not take care of the patient's symptoms, and the patient's family was wondering if the symptoms could be a result of an undetected infection with one of the components. It was noted that the patient fell a lot and did not seem to have impulse control, which is when they would have a fall. No outcome or diagnostics were provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indications for use: parkinsons dual movement disorders refer to manufacturer report # 3004209178-2015-16415.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5019305
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« Reply #133 on: September 07, 2015, 07:14:22 AM »

Model Number 37602
Event Date 02/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 338902836, lot# b9993681k, implanted: (b)(6) 2000, product type: lead. Product id: 338902836, lot# b9992982k, implanted: (b)(6) 2000, product type: lead. (b)(4).

Event Description
The healthcare professional of a foreign clinical study reported the patient had increasing mental problems. The patient was suffering from increased confusion, hallucinations, and disorientation. There was suspicion of parkinson dementia. The event resulted in a serious deterioration in the health of the patient and in permanent impairment of a body function or damage to a body structure. The patient was examined (b)(6) 2015 but no actions were taken. No surgical intervention was taken and no surgical intervention as planned. The event was considered ongoing. Patient medical history included diagnosis of parkinson's disease in 1985. The patient was currently taking movement disorder and or psychiatric medications. If additional information on intervention or outcome is received a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4993369
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