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dennis100
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« Reply #30 on: May 05, 2018, 12:56:47 AM »

Model Number (11)150331
Event Date 08/19/2016
Event Type  Injury   
Event Description
Cyberonics vns magnet model 220 implant on (b)(6) 2016. (b)(6) 2016 device short circuited causing potential damage to vagal nerve. Patient felt extreme heat and could not move for 24 hours. Device then shut off, had to be surgically removed and replaced on (b)(6) 2016. Picture of malfunction device shows bubble that formed to interfere with wires. Device sent back to cyberonics. Lot number 1464006.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7424951
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dennis100
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« Reply #31 on: July 20, 2018, 01:05:20 AM »

Model Number 102
Event Date 08/05/2010
Event Type  Injury   
Event Description
It was initially reported by the pt's spouse that following the replacement of the pt's pulse generator, he could not move his left arm. The pt was said to have indicated to the surgeon prior to discharge that he was experiencing pain at his left arm and he could not move his left arm. The pt's wife also indicated that the generator reported migrated and was in a different position than his previous generator. There was no known trauma or manipulation to the generator aside from the surgical placement. There was no prescription prescribed at the time of discharge by the surgeon. The treating neurologist later prescribed medication for the pt. The next day, the pt was said to have went to er due to pain in left arm and him not able to move left arm. The er took x-rays and put him into a sling. Good faith attempts to obtain add'l info from the surgeon have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830839
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dennis100
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« Reply #32 on: October 02, 2018, 12:45:35 AM »

Model Number 304-20
Event Date 11/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient visited an ent due to difficulty swallowing following surgery and was diagnosed with left laryngeal paralysis. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535913
« Last Edit: February 12, 2019, 03:38:31 AM by dennis100 » Logged
dennis100
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« Reply #33 on: March 26, 2019, 02:56:25 AM »

Model Number 100
Event Type  Injury   
Event Description
It was reported that the vns patient would lose motor function on the left side of her body during stimulation on-times despite low device settings. The surgeon believed that the current from the patient¿s device was leaking from the patient¿s lead and thus impairing the patient¿s motor ability. The patient would regain her motor function during stimulation off-times. The patient's device was disabled. No further information relevant to the event has been received to date.
 
Event Description
The programming history database was reviewed and history only showed one line of data from (b)(6) 2004. The patient's device was interrogated and found to be disabled. Settings were 0/10/250/7/180/0/250/7. The patient's device was explanted on (b)(6) 2004.
 
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4410392
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dennis100
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« Reply #34 on: April 02, 2019, 01:57:29 AM »

Model Number 103
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative

Event Description
It was reported that the patient had been recently diagnosed with gastroparesis. The gastroenterologist felt that there may be some damage to patient's vagus nerve which may have caused patient's stomach muscles to be paralyzed. Clinic notes were later received for patient's generator replacement as the device is nearing end of service. The patient's previous issues with device migration, scar tissue and erratic stimulation were reported in manufacturer report # 1644487-2015-04744.
 
Event Description
It was reported that the patient's neurologist was unaware of patient's issues and was not able to provide any information regarding the patient's current problems. Attempts to the ent physician for additional relevant information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5671428
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dennis100
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« Reply #35 on: April 04, 2019, 02:08:16 AM »

Model Number 103
Event Date 07/17/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the patient is having an increase in seizures. The patient¿s father reported that the patient has two types of seizures and one of them is increasing more than the other but he doesn¿t remember which type it was. The patient just had an eeg performed and the father believes the patient is having more seizures than prior to vns. It was later reported that the patient is currently at output=1ma and magnet output=1. 25ma. The patient¿s father indicated that prior to vns the patient was on keppra and had 120 ¿micro¿ seizures/minute, with the addition of onfi to the keppra he had 80 ¿micro¿ seizures/minute, but with the addition of vns to the onfi and keppra his seizures have increased. The father stated that the patient now has temporary paralysis in his left hand that he never had prior to vns and reiterated that the patient is getting worse with vns instead of better. Good faith attempts for further information from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3274212
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dennis100
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« Reply #36 on: July 23, 2019, 01:28:35 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190458
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dennis100
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« Reply #37 on: July 23, 2019, 01:29:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was initially reported that the patient complained of pain throughout her arm and numbness from her should to finger tips. It was stated that this occurred all of the time. The physician's office stated the diagnostics were within normal limits. The patient was informed to follow up with a surgeon, but the surgeon's office did not take the patient's insurance. The patient later reported that she had been experiencing problems with her arm and could not move it. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8189859
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