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Author Topic: Parents Beware  (Read 14950 times)
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dennis100
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« on: March 09, 2009, 12:08:44 AM »

Event Date 05/29/2001
Event Type Injury
Event Description
An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric reporter indicated vns therapy moderated a patient's atonic episodes, but the patient experienced "occasional hospitalizations for status epilepticus. " the patient passed away due to asphyxiation (reported on medwatch 1644487-2008-02703). The vns therapy system was explanted with "1. 5 cm of unstimulated nerve superiorly and inferiorly. " the electrodes were dissected from the nerve "revealing grossly normal nerve above and below the stimulator. " "abundant inflammatory cells were present around the stimulated nerve section. " "severe myelin loss and occasional myelin digestion chambers were seen in the nerve fibers. With modified trichrome and luxo fast blue stains, this loss was estimated to be nearly 90%. " good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Article: histological appearance of chronically stimulated vagus nerve in a pediatric patient. Pediatr neurosurg 2001, 35:99-102 2001 r shane tubbs. Et al.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1241164
« Last Edit: December 12, 2016, 02:58:02 AM by dennis100 » Logged
dennis100
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« Reply #1 on: March 11, 2009, 12:07:24 AM »

Model Number 302-20
Event Date 07/01/2010
Event Type Malfunction
Event Description
It was initially reported by the surgeon that he was performing a generator replacement on a pt and he noticed corrosion on the lead body right around where the lead inserted into the receptacle. Surgeon stated that the setscrew was corroded too. Surgeon noticed that the lead was green "like battery acid" in the thoracic pocket. When the surgeon connected the new generator onto the existing lead, he observed high impedance. Surgeon then exposed the neck site and noticed that the vagus nerve was gone. The nerve had essentially shrunken where the lead had been implanted. No pt adverse events were reported. Explanted products were returned to manufacturer for analysis. Analysis is currently pending on the explanted products. F/u with the treating physician revealed that he does not generally perform diagnostics if the pt is symptom free. Pt has been seizure free for two years now. Pt was referred to the surgeon for battery replacement as pt could no longer feel magnet stimulation. It is likely that the presence of stimulation during a lead break caused the discoloration of the lead and corrosion on the lead pin. Last good diagnostics results are unk as the physician does not perform diagnostics on daily basis.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1829516
« Last Edit: December 12, 2016, 03:00:44 AM by dennis100 » Logged
dennis100
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« Reply #2 on: January 13, 2011, 09:31:36 PM »

Model Number 302-20
Event Date 11/20/2007
Event Type Malfunction
Event Description
It was reported to mfr that a sys diagnostic test performed on the vns pts device revealed high lead impedance with output status ok. A second system diagnostic test performed at the same office visit revealed high lead impedance with the out put status at the limit. The pt presented at the physicians office with continuous neck pain and extreme coughing during stimulation of the device, which began the previous day. The pt reported having had pulled his left neck muscle the day prior. Additionally, the physician stated that the pt is a truck driver and does "a lot of movement in his neck, so he may have stretched the leads". It was recommended to set the normal mode and magnet mode output current ot 0ma, however the physician opted to decrease the settings from 1ma to 0. 75ma decrease the pulse width from 500usec to 250usec. The coughing and the pain improved with the setting change. The pt was referred to the implanting surgeon to have the device replaced. Preoperative interrogation of the device revealed that at some point the device output current had been set to 0ma. During surgery, it was observed that the negative coil was a "burnt yellowish color" and that the "nerve was burnt at the site where the negative electrode was in contact with the nerve". The area above and below the burnt area on the nerve was swollen. The entire lead, including the electrodes was removed,and a new lead was implanted. The generator was replaced prophylactically. Additionally, the surgeon reported that the pt was experiencing hoarseness prior to the device being removed. Attempts to obtain the explanted devices for analysis have been made, but have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2998029
« Last Edit: December 13, 2016, 11:49:23 PM by dennis100 » Logged
dennis100
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« Reply #3 on: January 19, 2011, 01:50:21 AM »

Model Number 302-20
Event Date 12/01/2014
Event Type Injury
Event Description
It was reported that the physician underwent explant of the vns and it was noted that the lead electrodes had been "scorched" on the patient's nerve. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4394209
« Last Edit: December 13, 2016, 11:50:01 PM by dennis100 » Logged
dennis100
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« Reply #4 on: January 19, 2011, 04:01:51 AM »

Event Date 01/07/2011
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
It was reported that the pt went to the clinic to have the vns turned on. The pt was programmed to 0. 25 ma and could feel stimulation. When the nurse left the room for a few minutes, the pt's parent alerted that the pt had collapsed on the floor, was non-responsive and chalky white. The nurse thought this may have been due to the vns and turned the device off. The pt was resuscitated and transferred to intensive care unit and now reported to be recovering. The pt's heart rate after device switched off and during resuscitation was 60 bpm. There are no further plans to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979719

« Last Edit: December 13, 2016, 11:52:10 PM by dennis100 » Logged
dennis100
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« Reply #5 on: January 19, 2011, 06:40:24 PM »

Model Number 103
Event Date 08/23/2013
Event Type Injury
Event Description
Additional information was received from the neurologist stating that the patient¿s bradycardia was possibly related to vns. The patient¿s device was programmed off. The patient did not have a medical history of bradycardia prior to vns.

Manufacturer Narrative
Date of event, corrected data: the initial manufacturer report incorrectly reported the date of the event.

Event Description
It was reported that the vns patient has been in the hospital icu with bradycardia and has coded at least once. A company representative went to the hospital to perform device diagnostics which were reported to be within normal limits. It was reported that the patient underwent cardiac workup and that the cardiologist found only vns as a potential source of the bradycardia. It was reported that the arrythmia events are not occurring with stimulation and they occur infrequently; however, the patient has had to be revived once or twice. The neurologist decreased the output current from 2. 5ma to 1. 5ma and is going to evaluate the patient to see if that helps. It was reported that there were no setting changes or medication changes that preceded the onset of the bradycardia. The patient's mother reported that the patient did not have any prior history of cardiac events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3363303
« Last Edit: December 13, 2016, 11:53:01 PM by dennis100 » Logged
dennis100
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« Reply #6 on: December 13, 2016, 11:21:21 PM »

Event Date 11/27/2013
Event Type Injury
Patient Outcome Life Threatening
Event Description
Patient found unresponsive with heart rate of 16 - was hospitalized and intubated; released after several days; patient noted to have increased seizures for the past few months - seizures are different from prior seizures in that she sometimes just drops to the floor without her usual aura and no post-ictal state. Suspect vns-induced asystole/bradycardia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3502109
« Last Edit: December 13, 2016, 11:53:35 PM by dennis100 » Logged
dennis100
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« Reply #7 on: December 13, 2016, 11:21:46 PM »

Model Number 101
Event Date 03/03/2008
Event Type Injury
Event Description
Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608
« Last Edit: December 13, 2016, 11:54:16 PM by dennis100 » Logged
dennis100
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« Reply #8 on: December 13, 2016, 11:22:14 PM »

I was nearly killed by that thing. Don't let what happened to me happen to your child!

My story made it to Reader's Digest:
http://www.vnsmessageboard.com/index.php/topic,4490.0.html
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