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dennis100
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« on: January 21, 2019, 12:12:56 PM »

Event Date 02/07/2012
Event Type  Malfunction   
Manufacturer Narrative
Artcile citation: ansari, s. , k. Chaudhri, and al moutuery. "vagus nerve stimulation: indications and limitations. " 97. 2 (2007): 281-86. Print.
 
Event Description
It was reported through a scientific article that a vns patient developed paralysis of the left diaphragm 4 months after vns stimulation. The event was directly associated with the output current and also if the patient's head was turned to the left during stimulation. Good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2480666
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dennis100
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« Reply #1 on: January 21, 2019, 12:14:07 PM »

Model Number 103
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement surgery. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Clinic notes dated (b)(6) 2013 note that the patient suffered a seizure while driving in (b)(6) 2013 and rear-ended another vehicle at 70 ml/h. It was noted that since then the patient's seizures have significantly worsened. It was noted that the patient's output current was reduced and she was doing somewhat better. It was noted that device diagnostics showed lead impedance "ok". The patient was sent for x-rays of the chest and abdomen. Chest x-ray report indicated that the x-ray did not identify any obvious lead fractures. Abdomen x-ray report indicated that the impression was a negative exam.
 
Event Description
Analysis of the returned lead and generator was completed on (b)(4) 2014. Analysis of the returned generator revealed no anomalies, and the device performed according to specifications. The output signal of the generator was monitored for more than 24-hrs and the results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead revealed that, other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative

Event Description
Follow up with the physician found that the physician tried the magnet on the patient and there were no muscle spasms, and therefore did not believe they were related. On (b)(6) 2013, the patient reported that she had a seizure the night prior and went to the ed. After being released from the ed, they patient was called back and told that the cat scan showed a tumor, cyst, or spot on her brain. Per the patient, the leads were on backwards and she was having a lot of gi problems. Follow up with the physician found that the patient was no longer his patient as of the last six to seven months. However, the patient was under the physician's care as of (b)(6) 2013. The patient's vns was found to be in proper working order and of proper function. Diagnostics on each visit were found to be appropriate as of the last visit on (b)(6) 2013. The patient has had seizures on and off since the initiation of her care in 2011. On her visit of (b)(6) 2013, the patient stated that she had a seizure the day previous on (b)(6) 2013. Over the last several months, the patient's vns has been adjusted. Her output has been increased. Her medications have also been adjusted appropriately. The physician received a fax from the patient on (b)(6) 2013 stating, "the last medication and vns adjustments that you made worked perfectly and i haven't had a seizure since my last appointment. " her last appointment before (b)(6) 2013 was on (b)(6) 2013. The patient alleges that has had increased seizures for six to seven moths; however, her seizures have been somewhat sporadic. The patient's chart also alludes that she has had a complaint of abdominal spasms, possibly not related to her seizures. The physician's inquiry did not reveal any relationship of these spasms to her vns device whatsoever, however, he stated that he is now aware that they patient told the manufacturer that her spasms are related to her magnet use. When the magnet diagnostics were performed in the physician's office on the patient's last visit of (b)(6) 2013, the patient had no evidence for abdominal spasm visually perceived by the physician nor complaint of the spasm at that time, verbally complained by the patient. No cause or contributory programming changes, medication changes, or factors that the physician is aware of seem to increase the patient¿s seizures. In summary, the patient¿s vns device appears to be working properly. There appears to be no connection between the patient¿s vns device and her complaint of increased seizure events. No additional information has been provided.
 
Event Description
On (b)(6) 2013, the patient reported that she has been having some "bizarre" symptoms lately and that she has been having an increase in seizures over the past six to seven months. She stated that she has about one per day. The patient is also experiencing muscle spasms in her abdomen on the left side that is affecting her bowel movements. On (b)(6) 2013, the patient reported that she is having issues with her magnet not helping her stop her seizures and that she is experiencing muscle spasms in her diaphragm and abdomen. The patient is not sure if the muscle spasms are related to her vns, but has noticed the spasms occur when she uses her magnet. Follow up with the physician found that the patient was seen in her office on (b)(6) 2013. The physician ran diagnostics and everything was ok. The physician stated that she swiped the patient's magnet and the patient was able to feel stimulation. There were no muscle spasms or any issues with the patient when she received the magnet stimulation. Per the physician, the patient appeared anxious, so it was discussed if she should see someone for her anxiety. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3283359
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dennis100
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« Reply #2 on: January 21, 2019, 12:14:56 PM »

Model Number 103
Event Date 04/20/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient was taken to the hospital on several occasions due to indigestion problems. His condition improved but he still had difficult eating by himself as he was fed via feeding tube due to his handicap and lack of motivation. The patient also experienced other adverse events that occurred after vns implant: the patient's mother believed they were due to vns. Toward (b)(6) 2012, the patient began having fecal vomiting and constipation and an aspiration pneumonia complication. At (b)(6) 2012, the patient had a diaphragmatic hernia with large defect. There was a gastro paresis with gastric retention complication post-operatively. In (b)(6) 2012, the patient had aspiration pneumonia with many epileptic seizures in (b)(6) 2012, there was more footage of epilepsy and a reduction of consciousness medical details were missing and proper narration of the event could not be confirmed due to communication errors between the patient's mother and the physician. The patient's current settings were provided. (output current: 1. ? ma, frequency: 30 hz, pulsewidth: 250 usec. ) attempts for additional information have been unsuccessful.
 
Event Description
Reporter indicated the patient's vomiting, syncope, pneumonia, and gastro-paresis are not felt to be related to the vns. The events are not related to vns stimulation either. The events are due to complications from the patient's illness. The patient is a "very disabled man" with multiple epileptic seizures daily and at night. The vns was temporarily disabled due to fever and illness. "there is no way to measure if he is suffering in any way of the stimulation of vns and he is too weak to suffer from anything else beside the illness. Maybe he will be better and then we will evaluate if the vns therapy should be continued or not". No causal or contributory vns programming or medication changes preceded the onset of the events. The patient does not have a pre-vns history of gastro-paresis. The patient does sometimes vomit with illnesses. It is unknown if the patient has a pre-vns history of syncope.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3011588
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dennis100
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« Reply #3 on: January 21, 2019, 12:15:57 PM »

diaphragm
Event Date 03/30/2016
Event Type  Malfunction   
Event Description
Additional information received that patient underwent surgery. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Xrays images were sent to the manufacturer by medical professional for review. Review of the images showed that the generator appears to be low in the chest, just above the diaphragm, in an abnormal placement. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared not to be placed in normal arrangement. The anchor tether seemed not to be fixed on the vagus nerve and the anode seemed to be partially dislocated from the nerve. No strain-relief loop and no strain-relief bend were found for the implant of the lead. Two tie-downs were used but their placement is not as recommended in the labeling. It could not be assessed from the images if a part of the lead is behind the generator. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Further information was received from the physician that the reason xrays were taken is they could not communicate with the generator. It was reported that the generator was not implanted auxilliary. It was reported that the vns patient felt following a strong seizure. The generator has dropped from its original location, and is in a lower location in the patient's body which is the suspected cause of the inability to interrogate the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6036347
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