Pages: 1 ... 3 4 [5]  All   Go Down
Print
Author Topic: Deep brain stimulator - Mental Health  (Read 62981 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #120 on: May 09, 2015, 02:14:40 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4653387
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #121 on: May 09, 2015, 02:15:25 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4658177
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #122 on: May 09, 2015, 02:16:09 AM »

Model Number 37602
Event Date 03/17/2015
Event Type Injury
Event Description
It was reported the patient was admitted to this hospital for a mental change and a kidney infection. The patient¿s healthcare professional (hcp) wanted a manufacturing representative to check to make sure the device was still functioning properly. The implantable neurostimulator (ins) was programmed on the left to 0-, 3+ at 4. 8v, 60 us, and 160 hz. Therapy impedance on the left side was measured to be 2638 ohms. Impedances on the left side, run at 1. 5v, were measured to be high with impedance of 2773 ohms being measured on electrode pair c-0. The left ins battery voltage was measured to be 2. 98v. The right ins was programmed to 1-, 3+ at 4. 5v, 60 us, and 180 hz. Therapy impedance on the right side was measured to be 2538 ohms. Impedances on the right side, run at 3v, were measured to be high on electrodes c-0, c-3, and 0-3. The right ins battery voltage was measured to be 2. 87v. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389-40, lot# j0406024v, implanted: (b)(6) 2004, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4664551
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #123 on: May 09, 2015, 02:16:45 AM »

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

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4712747
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #124 on: June 08, 2015, 07:00:31 AM »

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

Manufacturer Narrative

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4760034
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #125 on: June 08, 2015, 07:01:11 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4771432
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #126 on: June 08, 2015, 07:01:57 AM »

Model Number NEU_INS_STIMULATOR
Event Date 02/13/2015
Event Type Injury
Event Description
Lilleeng, b. , gjerstad, m. , baardsen, r. , dalen, i. , larsen, j. P. The long-term development of non-motor problems after stn-dbs. Acta neurologica scandinavica. 2015 mar 6 2015: doi: 10. 1111/ane. 12391. Summary: stimulation of the subthalamic nucleus (stn-dbs) is an established treatment with long-term beneficial effects on motor sym ptoms in patients with parkinson¿s disease (pd). The long-term development of non-motor problems after stn-dbs is not fully understood. In this study, we have studied how non-motor problems develop in patients with and without stn-dbs. We collected data from a prospectively followed cohort of patients that had been operated with stn-dbs 6¿9 years before final examination and compared our findings to the longitudinal development of non-motor problems in a non-operated, comparable reference population. In general, the non-motor problems of advanced pd seem to develop independently of treatment with stndbs. We found that depressions do not worsen after stn-dbs, and the montgomery and aasberg depression rating scale score in operated patients was substantially reduced from pre-operatively to post-operatively. Further, fatigue may represent an important unrecognized side effect of long-term stimulation, as fatigue was found to increase rapidly in operated patients already a year after surgery and continued to increase trough the 6- to 9-year follow-up. The non-motor problems of advanced pd seem to develop independently of treatment with stn-dbs. This may influence the strategy for choice of when to perform this therapy for eligible patients. Reported events: 1. 8 patients with stn-dbs for parkinson¿s disease had hallucinations at last follow-up 6-9 years after surgery. 2. 2 patients with stn-dbs for parkinson¿s disease had hallucinations 1-1. 5 years after surgery. 3. 5 patients with subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease developed dementia at last visit 6-9 years after implant surgery according to the diagnostic and statistical manual of mental disorders, third edition, revised (dsm-iii-r) criteria. All five developed dementia between one year after surgery and final visit. It was noted that the mean mini-mental state examination (mmse) score was 23. 4 at last study visit. 4. 4 patients with subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease did not have functioning devices. The source literature did not include any specific device information. Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative
Age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4771898
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #127 on: June 08, 2015, 07:02:43 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4792212
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #128 on: June 08, 2015, 07:03:21 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4805324
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #129 on: August 08, 2015, 09:46:58 AM »

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

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4900086
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #130 on: August 08, 2015, 09:47:36 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4902069
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #131 on: August 08, 2015, 09:48:19 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4929592
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #132 on: September 07, 2015, 07:13:24 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5019305
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #133 on: September 07, 2015, 07:14:22 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4993369
Logged
Pages: 1 ... 3 4 [5]  All   Go Up
Print
Jump to: