Pages: 1 [2] 3 4 5  All   Go Down
Print
Author Topic: Deep brain stimulator - Mental Health  (Read 69026 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


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