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Author Topic: Aneurysm  (Read 2760 times)
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dennis100
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« on: May 11, 2011, 11:32:35 AM »

Model Number 302-20
Event Date 06/28/2011
Event Type  Malfunction   
Event Description
The patient had full revision surgery on (b)(6) 2013, and their explanted products have at this time not been returned for analysis.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator and lead will not be returned for analysis.
 
Event Description
It was reported that the patient's vns is indicating high lead impedance. The physician believes the vns may have been damaged during cardiac surgery for valve replacement and aneurysm repair on (b)(6) 2011. However, the vns had not been checked since (b)(6) 2011. Both of the cardiac events are reportedly not related to vns therapy. Attempts for additional information have been unsuccessful to date. Surgery to replace the vns lead and generator is likely. No adverse events have been reported.
 
Event Description
Additional information was received indicating no x-rays were taken to evaluate for a lead fracture. The physician confirmed that the high impedance is believed to be a result of damage incurred during open heart surgery. The patient has had increased seizures since the time of the surgery that was originally believed to be related to the surgery however the increased seizures did not resolve after some time leading to the physician suspecting an issue. The seizures were noted as slightly improved following surgery and the overall increased seizure frequency was noted as being below the pre-vns baseline. The physician disabled the patient's vns when the high impedance was discovered on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2650301
« Last Edit: May 22, 2018, 01:40:21 PM by dennis100 » Logged
dennis100
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« Reply #1 on: May 12, 2011, 01:05:00 PM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/14/2016
Event Type  Injury   
Event Description
It was reported the patent had experienced obstructive sleep apnea related to vns. The physician explained that the vns settings were decreased and the obstructive sleep apnea resolved. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Clinic notes from three of the patient's office visits were later received. The clinic notes showed that the vns was working as intended as diagnostics results were ok. The notes also showed the patient was having trouble breathing when the device stimulates and the vns settings were adjusted for tolerability. The next set of notes speaks to the patient¿s severe headaches, poor sleep, and dyspnea on exertion, all worsening since the vns implant. The patient was unable to catch her breath after just a brief walk from the waiting room to the exam room, and her breathing had a very airy quality during the entire stimulation period. A fluoroscopic evaluation of the diaphragm movement was arranged and observed. No asymmetry of diaphragmatic movement was noted despite obvious dyspnea during the study. A bedside swallow test of water both between and during stimulation showed increase effort during stimulation, but no choking or aspiration. The integrity of the phrenic nerve function was confirmed, but dyspnea and dysphagia continued; therefore the vns frequency was turned down and the symptoms mostly resolved. The following notes showed the patient¿s seizures were half as frequent now. It was also explained that the patient has had headaches for years, which started after her aneurysm, and continue to get worse as she gets older.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6439990
« Last Edit: May 22, 2018, 01:41:22 PM by dennis100 » Logged
dennis100
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« Reply #2 on: June 08, 2011, 12:00:46 AM »

Event
« Last Edit: May 22, 2018, 01:41:42 PM by dennis100 » Logged
dennis100
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« Reply #3 on: February 25, 2016, 06:34:05 AM »

Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported via clinic notes received that the vns pt has a "history of intracerebral aneurysm with left mca stroke. " the notes also indicate "conventional cerebral angiography showed no recurrence of aneurysm (b)(6) 2007. " the relationship of this stroke to vns is unk. No device failure is suspected. Attempts for further info from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2372103
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