Pages: [1]   Go Down
Print
Author Topic: Violence  (Read 6396 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« on: October 22, 2012, 02:35:43 AM »

Model Number 101
Event Date 05/01/2004
Event Type  Injury  
Patient Outcome  Disability
Event Description
Reporter indicated that vns pt's family member died from head injuries as a result of physical violence toward the family member from the vns pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=531158

 
« Last Edit: May 03, 2018, 08:06:16 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #1 on: October 22, 2012, 03:17:28 AM »

Event Date 01/01/2004
Event Type  Injury  
Patient Outcome  Required Intervention;  
Event Description  
It was reported that the pt experienced psychosis in 2004 which was believed to be directly related to stimulation. The physician indicated that the pt's seizures were well-controlled by vns, however, the pt had psychotic episodes involving the desire to kill his parents. The physician indicated that the device was programmed off and the psychosis subsided. At a later date, the physician wanted to program the pt's vns device back on, however, the mother was adamant that it not be turned on due to the harm the pt may try to cause her.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1667284
« Last Edit: May 03, 2018, 08:05:54 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #2 on: October 22, 2012, 03:28:32 AM »

Event Date 04/01/2004
Event Type  Injury  
Patient Outcome  Required Intervention; Life Threatening Hospitalization  
Event Description  
Reporter indicated that vns pt was experiencing continued speech impediments, severe depression, delusional thoughts, severe memory problems, thoughts of wanting to kill their family members and hysterical crying. Treating neurologist discontinued topamax from the pt's drug regimen and reduced vns therapy system off time from 5 minutes to 3 minutes. Treating neurologist reportedly believes that the pt's speech problems were related to the topamax. The pt was started on depakote while in er and lexapro (for depression). Further follow-up revealed that additional adjustments to device settings and medication regimen were made, but that the pt's condition remains the same. Programmed normal mode output current was increased from 1. 5ma to 1. 75ma, programmed magnet mode output current was increased from 1. 75ma to 2. 0ma and depakote dosage was increased. The pt was also started on tranxene and was admitted to hosp for monitoring. Reporter stated that pt's depakote was increased. Initial reporter indicated that pt has been diagnosed with pseudo seizures. It was reported that treating physician left vns "on" because the physician is not ruling out true epilepsy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=529361

« Last Edit: May 03, 2018, 08:06:59 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #3 on: October 22, 2012, 03:36:10 AM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Further info from the treating neurologist revealed that the pt did not experience this degree of hostility prior to vns therapy.

Event Description
Reporter indicated that the pt became hostile, while the vns was activated, possibly putting themselves or others in danger. It was reported that the pt tried to stab their family member with a pencil. It was further reported that the device was turned off, and the hostility resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=638702

« Last Edit: May 03, 2018, 08:07:30 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #4 on: October 22, 2012, 03:42:32 AM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Disability Required Intervention
Event Description
Reporter indicated that vns patient has recently experienced very aggressive mood swings. The patient reportedly treatened family member with a knife. The patient has history of regular status epilepticus and has had a decrease in seizures with the vns therapy. Reduction in programmed output current and psychiatric evaluation were planned. Further follow-up revealed that the patient was placed in a psychiatric ward and was diagnosed with personality disorders. It was reported that no psychiatric syndromes were detected. The patient has started psychotherapy and no psychiatric medications have been prescribed to date. It was reported that the patient had no prior history if such disturbances.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481356
« Last Edit: May 03, 2018, 08:08:03 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #5 on: October 22, 2012, 04:08:47 AM »

Model
« Last Edit: May 03, 2018, 08:08:26 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #6 on: October 22, 2012, 04:17:08 AM »

Model Number 103
Event Date 08/01/2011
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Initial reporter, corrected data: the initial report inadvertently reported the reporter incorrectly.
 
Manufacturer Narrative

Event Description
The generator was received by the manufacturer for product analysis, however it has not been completed to date. The return product form indicated the patient had the generator explanted on (b)(6) 2012, due to the patient's family indicating that the vns made the patient violent. They subsequently wanted the device removed.
 
Event Description
It was reported on (b)(6) 2011 that the patient had some significant behavioral changes recently. Per physician, the patient has "gone crazy. " the patient bit both his horse and his dog so badly that the dog almost died. The patient's mother thought that this behavioral change was related to vns since it recently started and the patient was initially implanted on (b)(6) 2011. However, the physician reported that he did not think that this behavior was at all related to vns. To appease the patient's mother, the physician programmed the generator off a few days prior according to the tc (the exact date is unknown). Since programming the generator off, the patient was still exhibiting this odd behavior and has been placed in a child adolescent suicide unit to be monitored. The patient has not attempted suicide, but was placed there just based on his recent behavior in the fear that it might get worse. Per the physician on (b)(6) 2011, the device will remain off until the patient is stable. The neurosurgeon's office later reported on (b)(6) 2012 that they had a surgery consult appointment set to see the patient for generator explant. They did not have any clinical notes, but the mother called the office stating that her son's personality has changed so much for the worse that they had to move him out of their home into a facility. Though they had turned the device off, his psychiatrist thought it could even be from the placement of the lead on the vagus nerve causing the personality changes as they still exist with the device being off. Prior to vns implant on (b)(6) 2011, the case manager had a discussion with the mother on (b)(6) 2012 where the mother stated that her son was developing personality outbursts which tended to happen just prior to any seizure activity. Attempts for additional information from the referral physician have been unsuccessful to date. The patient had the generator explanted as scheduled on (b)(6) 2012. Since the lead was not explanted, the event is likely no longer believed to be related to placement of the leads on the nerve since the leads were not explanted. Attempts for product return were unsuccessful, as the rn at the facility indicated that she could not locate this device.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2688901
« Last Edit: May 03, 2018, 08:09:10 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7 on: March 08, 2013, 09:55:37 AM »

Model Number 101
Event Date 10/02/2000
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported that the patient had cognitive changes and starts to act semi-violent at higher settings, and that the benefits of the vns therapy is not noticeable. The physician was contacted for additional information but no response was received to date. It was also reported that the patient's vns device will be explanted, but the date of surgery is unknown to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967740
« Last Edit: May 03, 2018, 08:09:46 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #8 on: May 13, 2018, 12:37:02 AM »

Model Number 103
Event Date 11/23/2013
Event Type  Injury   
Event Description
On (b)(6) 2103, it was reported that this vns patient was a patient with psychiatric events characterized by behavior changes based on extreme aggression before vns implantation. In addition, the patient does not have a support network and there are periods when she is off of medication. The patient¿s psychiatric and neurological treatment is inconsistent and is variable. The patient reported that she wants to remove the vns due to lack of efficacy. The patient¿s mother reported that the seizures have decreased very little, almost not at all. The previous saturday, there was a domestic dispute, which erupted in a suicide attempt, attempted assault on the patient¿s family with a knife, and assault on the doctors who cared for the patient. The patient experienced an overdose that resulted from excessive intake of psychiatric medication. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative

Event Description
Additional information was returned on (b)(4) 2014. The patient had always been under psychiatric treatment, which means that in the physician¿s opinion, the vns therapy did not influence the suicide event as the patient has an important psychiatric problem from before implanting the vns. The suicide attempt occurred on (b)(6) 2013 and was not the first attempt. The attempt and assault were not believed to be related to vns. No interventions were taken, but interventions being considered included psychiatric medications and entering the patient to a psychiatric center. The physician believed that vns therapy was effective for depression and seizure control. The patient says she feels pain and wants to retire the vns because she has not improved the seizure, but her mother and physician said otherwise. Vns settings had remained low. The patient was very unstable during medical visits. Device settings were provided.
 
Event Description
Additional information was received that the patient¿s suicide attempts were not influenced by vns therapy but rather due to the patient¿s pre-vns psychiatric problems. The report of pain began during the suicide attempt, but the physician believed this was due to the patient¿s psychiatric condition. The physician believed vns therapy was positive for the patient. The pain was in the chest at the generator site and was not with stimulation. The patient feels pain, and she wants to retire the vns because she has not had improved seizure control; however, the caregiver and physician disagree.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3534756
Logged
Pages: [1]   Go Up
Print
Jump to: