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Author Topic: Personality/Behavior  (Read 22456 times)
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dennis100
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« Reply #90 on: April 30, 2018, 01:41:39 AM »

Model Number 303-20
Event Date 05/07/2013
Event Type  Injury   
Event Description
Reporter indicated a vns patient presented with changes in scar tissue healing on the neck on (b)(6) 2013 following initial vns implant surgery on (b)(6) 2013. The patient was also very restless, but when the vns was disabled the patient calmed down. It was thought there may be a lead dislocation or ¿akzidenteller stimulation of vessels¿, but device diagnostics indicated normal function with 2066 ohms. X-rays may be performed. The reporter is concerned that surgery may be needed to rectify the situation. Attempts for additional information are in progress.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
Reporter indicated the vns settings were not changed, and there was no issue with stimulation. The vns was turned back on and programmed to 1 ma. No interventions are planned, and the patient is ¿doing ok¿. X-rays were received to the manufacturer for review. No generator views were provided. There were no acute angles or frank lead breaks observed in the available views.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3148350
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dennis100
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« Reply #91 on: May 12, 2018, 01:32:31 AM »

Model Number 102
Event Date 10/04/2013
Event Type  Injury   
Event Description
It was reported that the patient was experiencing an increase in seizures and aggression. It was reported that prophylactic generator replacement was recommended to the patient. It was reported that the patient underwent prophylactic generator replacement surgery on (b)(6) 2013. It was reported that the increase in seizures was likely due to the vns decreasing efficacy. It was reported that it was unclear why the patient experienced an increase aggression, but that perhaps the vns decreasing efficacy caused the increased irritability. It was reported that the patient experienced one seizure every 2-3 weeks or up to 8-10 a month. It was reported that the patient is delayed and has some behavior issues. No causal or contributory programming or medication changes preceded the onset of the increased seizures and increased aggression. The generator was received for analysis on 10/30/2013. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
The generator was explanted prophylactically. Visual examination, performed on the test bench, identified scratches/dents on the can and scratches on the header most likely associated with manipulation of the device during the explant procedure. The negative septum appears cored. There is no evidence of dried body fluid or corrosion in the connector block. Other than typical explant procedure related observations, no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs showing no signs of variation in the pulse generator¿s output signal and demonstrating that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3453346
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dennis100
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« Reply #92 on: October 08, 2018, 01:33:59 PM »

Model Number 103
Event Date 03/22/2012
Event Type  Injury   
Event Description
Reporter indicated a patient had the vns generator explanted due to infection on (b)(6) 2012. The generator had initially been implanted on (b)(6) 2012, and pre-operative antibiotics were given to the patient for infection prophylaxis. Attempts for further information are in progress.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution. The lead product information is unknown, and attempts to obtain lead information have been unsuccessful to date. Hence, sterility of the lead product cannot be confirmed.
 
Event Description
Reporter indicated the patient was admitted to the hospital on (b)(6) 2012 for increased seizures. The patient's medication was adjusted and the patient was released. Several days later, the patient had swelling around the vns generator site. No fever was present. The patient was also not "acting like himself. " blood tests suggested an infection may be present, and an x-ray confirmed the suspected infection. The infection began in the vns generator pocket and tracked up the vns lead to the cervical area. The lead and generator were both removed. Tissue around the generator site was noted to be inflamed and purulent fluid was noted. The wounds were irrigated with antibiotic solution and closed. At the (b)(6) 2012 surgical follow-up visit, the wounds were healing well. Sutures were removed. No odor or drainage was present. Steri-strip dressings were placed over the incisions. The patient was back to his baseline behavior and "subjective" self. The patient will wait 3 months before considering reimplant of a new vns. The patient has been released back to the care of the neurologist. The reporter indicated the increased seizures were probably infection related. After the infection was treated, the seizures returned to baseline frequency.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2541257
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dennis100
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« Reply #93 on: November 07, 2018, 02:02:03 AM »

Model Number 103
Event Date 10/01/2012
Event Type  Malfunction   
Manufacturer Narrative
A communication error prevented the correct value from being programmed into the device during both electrical tests which resulted in the pulse not disabled.
 
Event Description
It was initially reported that the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. The generator would not communicate in the product analysis lab. The battery was found to be depleted, 1. 532 volts as measured with the can removed and battery still attached to the pcb. Post burn-in electrical test results showed that the pulse generator pcb module performed according to functional specifications except for the c4 out of specification condition. The cause for the out of specification c4 capacitor (v cpu) value is likely associated with component aging. A review of pre-temp and post-burn automated electrical test results (performed during manufacture of the product) revealed that a communication error (e. G. Test results display "9999") prevented the correct value from being programmed into the programmed into the device during both electrical tests which resulted in the parameter's current state. No other issues were identified with the returned generator. During electrical testing of a generator's (model 103-106) printed circuit board (pcb), the generator is calibrated to measure voltage using a two point curve from which the trim values diagvbatb and diagvbatm are assigned as the gain and offset of this calibration curve. Diagvbateos threshold corresponds to the threshold level at which the generator will disable output as an eos response and is set at manufacturing after the establishment of diagvbatm and diagvbatb.
 
Event Description
Clinic notes were received providing that the patient can tell when the battery gets low due to changes in behavior and speech but it has little effect on seizures; they are perhaps less intense.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2916322
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dennis100
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« Reply #94 on: February 09, 2019, 02:11:17 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2018
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient had passed away due to sudden unexpected death in epilepsy (sudep). The patient's mother indicated that the vns contributed to the patient's passing; however, the physician reported that was not the case. The physician indicated that the patient's death was not attributed to vns. The last system diagnostics known for the patient were within normal limits. The mother reported that on the day of the patient's death he had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours but he was eventually pronounced dead at 11 am. The patient's mother additionally reported that the patient's vns had been turned off for an mri a few weeks before the patient's passing and was turned on by a different neurologist. The mother reported that the son thought the neurologist had turned on the stimulation too high and wanted the generator explanted. She reported that the patient's generator would constantly turn on and off, and that it affected the patient's vocal cords. She reported that the patient's device was not helping him and that there was an increase in seizure frequency. She also reported that the patient had horrible heartburn and was agitated the day before he passed away. The patient's autopsy came back negative for any abnormal tests. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242124
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dennis100
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« Reply #95 on: March 09, 2019, 02:26:02 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/27/2018
Event Type  Injury   
Event Description
It was reported that the patient presented with dilated pupils, tremulous behavior and showed signs of horner's syndrome after vns implant surgery. It was reported by the that the patient's symptoms appeared to be the same when the device output current was programmed off and therefore the patient's generator was programmed on. The physician indicated that the patient's horner's syndrome was related to the vns surgery. It was reported that the patient's symptoms had not resolved post surgery to date. The reported tremulous behavior was reported to be caused by the patient's seizures per the physician. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8296503
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dennis100
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« Reply #96 on: March 10, 2019, 02:16:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2016
Event Type  Injury   
Event Description
It was reported in clinic notes that the patient experienced a new onset of behavioral/mood symptoms following the original implantation. In the notes, the patient¿s behavior issues were given as frequent mood swings, hyperactivity, and distractibility. Neuropath testing confirmed the patient had behavioral disorders and speech delay. His behavior issues were treated with medication. The patient¿s diagnosis was given as autism spectrum disorder and behavioral disorder. Programming history was reviewed. At the time of the complaint regarding behavioral problems, the device diagnostics were normal. No anomalies were seen. No other information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8304977
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dennis100
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« Reply #97 on: April 07, 2019, 02:36:44 AM »

Model Number 1000
Device Problem High impedance
Event Date 08/06/2018
Event Type  Malfunction   
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.
 
Event Description
High impedance was found during an internal programming history review. Design history records were reviewed for the generator. The device passed all functional specifications prior to distribution. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generators compared to those reported by model 103-106 generators. As indicated in the physician's manual, high lead impedance (>/=5300 ohms), in the absence of other device related complications, is not an indication of a lead or generator malfunction. The patient's physician has reported that the family feels that the patient has experienced behavior side effects and also urinary incontinence and blamed the vns for these events, despite the physician explaining that the vns may not be causing those events. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8425237
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dennis100
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« Reply #98 on: June 21, 2019, 12:35:54 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/11/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Patient's caregiver reported that the patient's heart rate was in the upper 40s range and mentioned that this occurred when magnet was swiped. This was mentioned briefly but was not confirmed. During the next clinic visit, the caregiver reported bradycardia with heart rate in the range of 30 to 50 bpm. The physician mentioned that the caregiver saw that but that she is not sure how it was measured. During the patient's clinic visits, the heart rate had been 65, 65 and 63 bpm for the past three visits. But as the bradycardia may be related to vns, the physician decided to decrease the frequency of the settings. Diagnostics were normal and there were no warning messages. The caregiver was asked to take patient to a cardiologist and get holter monitor to check on the bradycardia. The physician did not know if this was done to date. A few days later the caregiver reported that the patient was agitated, angry, & being aggressive and associated it to the setting change. The physician did not think the behavior issue was related to vns or the frequency change as the patient has had behavior issues even prior to vns therapy. As the caregiver was particular about changing the settings, the frequency was adjusted again to 25 hz. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7201460
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dennis100
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« Reply #99 on: July 05, 2019, 10:40:51 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/03/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was initially implanted with vns. The patient is autistic and since his third post-op day, the patient has had a drastic increase in aggressive behavior, sleeping difficulties, and agitation. Autostim threshold was altered and all settings were turned off except for magnet mode. The patient's behavior was still bad and is assumed to be due to the feeling of the device itself as opposed to the stimulation. Parents of the patient want the device explanted. Information was received indicating that the aggressive behavior, sleep disturbances and agitation are believed to be due to discomfort of the device. The patient was referred to have device explanted for patient comfort and to preclude serious injury. It was stated that it is to preclude serious injury due to self-injury behaviors. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8695881
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dennis100
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« Reply #100 on: July 11, 2019, 01:29:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's husband reported that the patient had a psychotic break down and has been inpatient for about the last month. The husband believes vns settings are too high which is causing his wife's problems. He noted that his wife has reacted horribly to magnet swipes, stating that she was having pain in the neck and coughing. The patient's group home later called and reported behavioral changes and frequent urination for this patient. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8667403
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