Pages: [1] 2 3 ... 10
 1 
 on: Today at 01:35:31 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 10/01/2014
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that a vns patient had passed away. The patient had a heart attack in 2014, no exact date given, and passed away. The patient reportedly had chronic heart problems. A review of the manufacturer's in house programming history identified the patient's last known settings in (b)(6) 2014. All diagnostic results available were within expected limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5987277


 2 
 on: Today at 01:34:54 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem No Known Device Problem
Event Date 09/10/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported on (b)(6) 2015 that the patient began experiencing discomfort in the chest that day or the day prior. She was being seen by her primary care physician on (b)(6) 2015. The patient's vns device was checked a couple days prior, and everything was reportedly okay. The patient was undergoing blood work to confirm that this was not cardiac in nature, but it was initially not clear on the relationship to vns. Upon follow-up, the treating neurology nurse practitioner reported that the patient had a myocardial infarction. Attempts to the patient's primary care physician have been unsuccessful to date. The nurse practitioner was unable to provide further information. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient has a "leaky heart valve" which is believed to be unrelated to vns per the neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5154890

 3 
 on: Today at 01:33:04 AM 
Started by dennis100 - Last post by dennis100
Device Problem Electrical issue
Event Date 02/25/2015
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
It was inadvertently not provided in follow-up report#6 that the surgery had occurred on (b)(6) 2016. The explant date of the device was inadvertently not provided.
 
Event Description
Additional data was received and review of the programming/diagnostic history shows that the device is still functioning within normal limits. Additional information was received that the patient underwent the cardioversion procedure on (b)(6) 2015. There were no precautions taken during the procedure. A magnet was not used to disable it during the procedure as the operators thought the device was end of life.
 
Event Description
An abstract written by the patient's physician was received on 12/10/2015. The abstract stated that the patient was admitted to the hospital for new-onset atrial fibrillation. Chemical cardioversion was attempted, but was unsuccessful. After being cleared with a tee for an intracardiac thrombus, the patient underwent dc cardioversion to sinus rhythm. Shortly after the dc cardioversion, the patient experienced persistent dysphagia and periodic (in synch with stimulation) throat irritation, dry hacking cough, and symptomatic bradycardia with heart rate dropping to the 20s. The periodic symptoms resolved after the device was deactivated with the magnet, but the patient remained dysphagic. On fluoroscopy for swallow evaluation, the vns leads could be seen exposed in the soft tissue of the neck. The physician believed that the patient's nerve was burned, which caused the persistent dysphagia, and that the vns lead was "naked" and was shocking the patient's neck soft tissue and causing the periodic issues. There were still no plans to replace the generator, as this would aggravate the patient's condition.
 
Manufacturer Narrative
Date received by manufacturer: 12/20/2017. (b)(4).
 
Event Description
The patient was referred for full revision surgery. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer per policy, and it was reported the product may have been discarded.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient sustained damage to his vocal cords following a cardioversion procedure.
 
Event Description
It was reported that the patient experienced sharp painful stimulation every 90 seconds after undergoing an electrical cardioversion for atrial fibrillation with rapid ventricular rate. Prior to the cardioversion, patient had a transesophageal echocardiogram but was reported to be able to swallow without issues following this procedure. After the cardioversion, the patient was having significant and periodic bradycardic events with a heart rate drop from the high 90's into the 30's. Patient would simultaneously moan, bear down, and complain of severe neck pain. Once the vns was turned off, the events ceased. When a system diagnostic test was attempted, the patient again had bradycardia and the programming wand was quickly removed. I didn't think it wise to try that again. With the device off, the patient was tested with modified barium swallow and found to have a complete dysphagia. This test will likely be repeated within a few days to assess any improvement. It is unknown if the device was programmed off when the patient had the cardioversion procedure. X-rays were taken of the neck and there were no obvious anomalies identified in the images received. The physician believes there may be a micro fracture in the lead and stimulating the neck near the vagus nerve causing the pain that triggered a vagal response in a physiologic manner as opposed to via direct vagal stimulation. The physician is concerned that the patient now has a vagus neurapraxia due to electrical injury. It was also reported that there is no definitive way to test for this to be sure. Additional relevant information have not been received to date.
 
Event Description
It was reported that the patient still experienced pain in neck area due to the cardioversion procedure. It was also mentioned that the vns therapy was working well for the patient until the cardioversion incident. The patient also underwent surgery on the throat and reported to have probably burnt his vocal cords. The physician mentioned the theory that the lead passed the energy to the nerve during the cardioversion procedure, which resulted in the patient's adverse events. Review of the programming and diagnostic data for this patient indicates that the impedance value was 2107 ohms on (b)(6) 2015 and has been consistently between 2100 and 2400 prior to cardioversion procedure. On (b)(6) 2015, the impedance value was 1350 ohms. The impedance value on (b)(6) 2015 is 1379 ohms.
 
Event Description
Additional information was received that the patient still has pain despite vns being off. A report on the cardioversion procedure was also received stating that the procedure occurred on (b)(6) 2015 at 15:02. Synchronized bi-phasic cardioversion was performed with a medtronic lifespak 12 cardioversion device. Adhesive patches were used and 200j of energy was used to shock. The patient has a history of hypertension, a vns for seizure disorder, restless leg syndrome, and a new onset of atrial fibrillation. Echo findings showed no laa thrombus. The ejection fraction from the echo was 65%. During the procedure, the patient was brought to the electrophysiology lab in a fasting state after informed consent was obtained. Hemodynamic monitoring was established, and anesthesia was administered. Synchronized biphasic cardioversion was performed, the patient was reassessed, and the patient left the lab in a stable condition. Results showed that pre-rhythm was atrial defibrillation, and the post-rhythm was sinus. 200j of energy was delivered externally. There were no noted complications, and the dc cardioversion was deemed successful. Clinical course was to be observed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618197

 4 
 on: Today at 01:32:10 AM 
Started by dennis100 - Last post by dennis100
Event Date 07/22/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had arrhythmia and was to undergo tee-guided cardioversion. It is unknown whether the patient┬┐s arrhythmia was related to vns. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the patient does not have the arrythmia due to vns. The physician indicated that the routine cardioversion is for an unrelated condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012875

 5 
 on: Today at 01:30:35 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that physician had to increase the vns system threshold for auto stimulation because the patient had dyspnea and tachycardia at rest following threshold reduction to 30%.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6098424

 6 
 on: Today at 01:25:08 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was reported that pt has several issues with respiratory distress when he sleeps. In the last 2 months off and on, the skin around his collarbone would sink in and he would wheeze. Pt's caregiver attributed this to recent adjustments of the vns and dismissed it as it was infrequent; however, during his nap recently, he had his abdomen sinked under his ribs and had erratic breathing for about one min. It happened again fifteen mins later but much more violently. His heart was reportedly beating rapidly and his breathing was a high pitched wheeze. His entire abdomen was spastic. It took about a min for the pt to get back to normal. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1153329

 7 
 on: Today at 01:24:24 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was reported that a patient was experiencing a rapid heart beat. Follow up with the patient's treating physician revealed that the cause of the increased heart rate was unknown. However, diagnostics showed that the patient's device was functioning properly. The physician has turned off the patient's device to see if the issue resolves.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1237258

 8 
 on: Today at 01:23:39 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Event Date 05/03/2010
Event Type  Injury   
Event Description
A vns pt called and reported that she had been at the hospital on (b) (6) 2010 because the device had been choking her. She had been admitted to the hospital on (b) (6) 2010 because after using her magnet, she felt like her heart was racing. She reported, the hospital treated her like a cardiac pt because they thought she was having a heart attack and believed the vns was the cause. Additionally, she reported that after her initial implant she was unable to eat. Good faith attempts thus far have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1716183

 9 
 on: Today at 01:23:05 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 06/04/2008
Event Type  Injury   
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities or anomalies noted.
 
Event Description
Initial reporter indicated that the pt was experiencing dyspnea with stimulation. Taping the magnet over the vns resolved the dyspnea. The pt had their vns programming adjusted a month earlier for painful stimulation and resolved but then started having the dyspnea with stimulation. All diagnostics were within normal limits. The pt reported an episode where she "stops breathing". The pt additionally reported neck "spasms". Reported "that it grabs at the neck and then results in her sweating, can't breathe, and heartbeat increasing. She's not sure whether the last three symptoms are due to the vns or due to her getting nervous about the grabbing. She feels like it paralyzes her neck where she can't get air down and her mom said she turned purple yesterday. It happens about once a day and using the magnet won't make it go away". The pt normally doesn't feel stimulation so did not know whether the neck spasm is during stimulation or not but it doesn't seem to occur every few mins. There was no report of any trauma or accident. X-ray review by mfr did not reveal any gross lead discontinuities or anomalies that may have contributed to the reported event. The pt underwent generator replacement surgery. During the surgery a large amount of scar tissue was noted around the pt's lead. Good faith attempts are being made for the prod return for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077469

 10 
 on: Today at 01:19:57 AM 
Started by dennis100 - Last post by dennis100
Model Number 101
Event Date 08/03/2010
Event Type  Injury   
Event Description
Reporter indicated a vns pt was experiencing heart palpitations and was to consult with a cardiologist. Vns generator replacement surgery is planned due to current generator end of service, but a surgery date has not been set. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947679

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