Pages: 1 2 3 [4] 5  All   Go Down
Print
Author Topic: Deep brain stimulator - Mental Health  (Read 69024 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
« Last Edit: November 08, 2014, 04:40:26 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
« Last Edit: November 08, 2014, 04:41:12 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
« Last Edit: November 08, 2014, 04:45:34 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
« Last Edit: November 08, 2014, 04:45:56 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
« Last Edit: November 08, 2014, 04:47:03 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
« Last Edit: November 08, 2014, 04:47:26 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
« Last Edit: November 08, 2014, 04:47:45 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4259314
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4375896
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515835
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4545859
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
Pages: 1 2 3 [4] 5  All   Go Up
Print
Jump to: