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Author Topic: Dysautonomia  (Read 268 times)
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dennis100
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« on: April 22, 2019, 01:47:43 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/03/2016
Event Type  Injury   
Event Description
It was reported by the patient that she had been hospitalized four times since being implanted with a model 106 generator due to device overstimulation. The patient believed that her heart defects may have caused the overstimulation from autostimulation. Two of the four hospitalizations lasted longer than eight days. The patient's device was disabled by the magnet and she said she felt a little better. The symptoms from overstimulation were not reported. Follow up with the patient's neurologist found that the patient had been admitted to the hospital due to passing out episodes with an unknown etiology, but suspected to be due to dysautonomia. The physician indicated that it was unclear if the vns was related to the patient's symptoms. It was indicated that the patient's symptoms did not get better with magnet mode disablement. She indicated that a possible cause was heart problems and it was unclear if the autostimulation feature was playing a role in these symptoms. Reportedly, the patient's current generator's settings had not changed from the previous generator's setting besides the addition of the autostimulation feature. The patient's generator was disabled to see if the patient's symptoms improved. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6283389
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dennis100
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« Reply #1 on: April 22, 2019, 01:48:31 AM »

Model Number 106
Event Date 10/08/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the cardiologist that the patient presented with syncope. The patient was hospitalized. During the visit, the patient had 2 cases of asystole. The vns was reported to be disabled by the magnet. There were no more instances of asystole after disablement. However, the cardiologist could not say that the disablement stopped the asystole as a pacemaker was also implanted into the patient the next day. The patient was noted to have a history of severe autonomic dysfunction and encephalopathy. The cardiologist reported at a later date that he had seen the patient recently and she is doing fine. He believed that the vns was not the problem and did not contribute or cause the syncope or asystole; the patient simply had severe autonomic issues. However, the physician did not manage vns devices and was unaware of how the device functioned. No further relevant information has been received from the cardiologist to date. Attempts to contact the patient's follow up physician were made, but no relevant information has been received to date.
 
Event Description
A report was received from the physician with additional information. The patient had a history of recurrent syncope and pre-existing medical conditions of seizure disorder and alcoholic encephalopathy. Rather than describing the heart stopping event as asystole as he previously did, in this report, the physician described it as bradycardia. He indicated in this report that a 12 seconds heart cessation event occurred, but described it as a pause of the heart rather than as the heart stopping as he previously did. Prior to the events, the patient's heart rate was within a normal range (in the 70 beats/ minute range). It was noted that no traumatic events occurred to the patient prior to the arrhythmia, nor were there any triggers or medication change that could have contributed. The arrhythmia did not correlate with the on time of the device and no device diagnostics or interrogation was performed. The only intervention taken was the hospitalization and the placement of a pacemaker on (b)(6) 2016. The generator is currently programmed on and the arrhythmia has not recurred as of (b)(6) 2016. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6073121
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dennis100
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« Reply #2 on: April 22, 2019, 01:49:25 AM »

Model Number 103
Device Problem Use of Incorrect Control Settings
Event Date 08/07/2015
Event Type  Injury   
Event Description
It was reported that the patient has experienced autonomic dysfunction, low blood pressure, headaches, swallowing issues, decreased perception of stimulation, and loss of breath during exercise prior to a recent vns settings adjustment. It was also reported that the patient stayed at a clinic for three weeks and had her vns turned off for five days with no resolution of the symptoms. It was reported that the vns had not been medically ruled out. No additional relevant information has been obtained to date.
 
Event Description
Additional information was received from the patient's neurologist that he does not believe that any of the patient's symptoms are related to vns. The symptoms do not only occur with stimulation and do not resolve when the device is disabled. Settings and diagnostics for the patient were reported to be as intended and within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5046658
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dennis100
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« Reply #3 on: April 22, 2019, 01:51:26 AM »

Model Number 102
Event Date 03/01/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
A patient reported experiencing nerve damage, chronic gastroparesis, and chronic diarrhea soon after having her vns device implanted on (b)(6) 2012. The patient also reported that she had gastric issues prior to vns, and she had gerd surgery in 2014 but the issues didn't get much better. The patient's treating neurologist stated that she did not believe the patient had experienced nerve damage and also provided clinic notes dated (b)(6) 2016. The clinic notes stated that the patient began intermittently vomiting shortly after vns surgery and had seen multiple gi doctors that suggested vns may be a factor. The vomiting and gastric issues caused the patient to experience weight loss. Clinic notes stated that the patient believed the gastroparesis developed as a result of vns surgery due to the relationship between the vagus nerve and the digestive system. The device was programmed off to help the physician determine if the gastroparesis was related to vns on (b)(6) 2016. The physician recommended waiting at least 3 months before determining if the vns device should be explanted. The physician also stated that she believed the patient's constellation of symptoms could indicate dysautonomia. No surgical intervention has been reported to date. No further relevant information has been received to date.
 
Event Description
Information was received indicating the patient underwent an explant surgery due to the patient's discomfort and because her medical diagnosis had changed. The generator was returned the manufacturer and is currently under analysis. No further relevant information has been received to date.
 
Manufacturer Narrative
Explant date, correction data: supplemental mdr #1 inadvertently did not include that the device had been explanted.
 
Event Description
The returned generator had analysis completed. The device output signal was monitored for more than 24 hours in a simulated body environment and verified that the generator was able to provide the expected output levels for the entire monitoring period. The device performed according to all functional specifications. A visual analysis of the generator did not show any adverse conditions and was consistent with those typically seen after device removal. Portions of the explanted lead were also returned for analysis. The condition of the returned lead portion was consistent with those that typically exist following explant. No anomalies were noted and no discontinuities were identified. The setscrew marks on the connector pin provided evidence of a good mechanical and electrical connection between the lead and the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5753203
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