Pages: [1] 2 3 ... 10
 1 
 on: May 20, 2019, 10:11:31 PM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 05/01/2006
Event Type  Injury   
Event Description
A cardiologist called and asked for labeling on the vns and cardioversion. She had a patient who had a vns implanted, hospitalized in icu that was in afib and she needed to cardiovert them before putting a pacemaker in. The patient was having cardiac pauses as well and she did not think it was related but was not sure. Actual start date of event unknown. Said that it occurred during the off time so that she did not think so. She said that the patient was elderly so most likely related to that but could not be 100% sure. It was asked if she had tried to disable the device to rule out the vns and she said no, since she was not having it during the on time. She felt that she did not need to do that and that it was most likely related to her age. Patient was set to 7 secs on time 3 mins off time. The patient had sick sinus syndrome with severe bradycardia requiring their pacemaker placement (b)(6) 2006 in the right chest area. No interactions with their vns were reported. During this time frame, the patient was also found to have paroxysmal atrial fibrillation and was placed on coumadin. After implant with their pacemaker, the vns device and pacemaker are reportedly were working well and the patient doing fine as well. The patient had been implanted since (b)(6) 2005, and there is no indication that this event coincides with vns stimulation. No further information will be provided in regards to their cardiac event from their physician's office. It was later reported in (b)(4) 2013 that the patient had died. (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972148

 2 
 on: May 20, 2019, 10:10:07 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Defibrillation Problem
Event Date 12/01/2013
Event Type  Injury   
Event Description
It was reported that the vns patient was to be hospitalized in (b)(6) 2015 for disabling the vns stimulation and enabling it again in a controlled environment. It was reported that the patient had undergone cardioversion in (b)(6) 2013 as a treatment for heartbeat disorders that had followed myocardial infarction. The vns stimulation was turned off during cardioversion by fixing the magnet on the generator. After cardioversion and removal of the magnet the patient experienced an extreme burning sensation in the throat and neck, suffocation, flushing and eyes watering. The reported effects stopped when stimulation was stopped by fixing the magnet on the generator. The pulse generator was programmed at the mildest stimulation settings and the side effects improved. The pulse generator was programmed at output current 1. 50 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. Further information was received indicating that the patient¿s system was tested on (b)(6) 2013 and system diagnostics returned impedance within normal limits with 3119 ohms. On (b)(6) 2013 the pulse generator was programmed at output current 0. 75 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. On (b)(6) 2013 the pulse generator was programmed at output current 0. 5 ma, frequency 20 hz, pulse width 250usec, 30sec on and 5min off. It was later reported that the patient underwent cardioversion again on (b)(6) 2014 and that the pulse generator was disabled by fixing the magnet on the generator. After cardioversion was completing and the magnet was removed the patient experienced painful stimulation. The patient could not tolerate the output current set at 1. 75ma. The output current was programmed to 0. 5ma. The patients vns system was tested and system diagnostics returned impedance results within normal limits. Further information was received stating that before the first cardioversion session on (b)(6) 2013 system diagnostics returned impedance results within normal limits with impedance = 3781 ohms, and ifi=no. After the first cardioversion session, system diagnostics on (b)(6) 2013 returned impedance results within normal limits with impedance = 3119 ohms, and ifi=no. Before the second cardioversion session on (b)(6) 2014 system diagnostics returned impedance results within normal limits with impedance = 2922 ohms, and ifi=no. After the second cardioversion session, system diagnostics on (b)(6) 2014 returned impedance results within normal limits with impedance = 2429 ohms, and ifi=no. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the available programming and diagnostic history. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution.
 
Event Description
Further information was received indicating that the patient had undergone bi-phasic cardioversion in the morning with adhesive patches in anterior-lateral left position. The energy value used for the cardioversion was 100j. The generator's decoder spreadsheet was reviewed. On (b)(6) 2013 the patient underwent the first cardioversion treatment. On (b)(6) 2013 the battery voltage was 3. 440v and the lead impedance 3782 ohms. On (b)(6) 2013 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the patient underwent the second cardioversion. On (b)(6) 2014 the battery voltage was 2938v and the lead impedance 2401 to 2430 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877621

 3 
 on: May 20, 2019, 10:08:56 PM 
Started by dennis100 - Last post by dennis100
Model Number 102R
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 06/02/2017
Event Type  Malfunction   
Event Description
It was reported by the physician that patient's device settings were changed following a defibrillation. The settings were changed back by the physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7402670

 4 
 on: May 20, 2019, 10:07:08 PM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported by that patient underwent a cardioversion procedure. Following the procedure the patient¿s generator pocket appeared infected and the skin around the generator was breaking down which caused the generator to extrude. The physician was concerned that the cardioversion procedure could have contributed to the generator extrusion. The patient was referred for surgery due to the generator extruding from the body. The patient's generator was explanted and no replacement occurred at that time. A manufacturing review was performed which showed the generator and lead were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
Further information was received from the physician that the patient did not have an infection at the generator site. The physician did not know what the cause of the extrusion was.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6552915

 5 
 on: May 20, 2019, 10:06:24 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/26/2017
Event Type  Death   
Event Description
It was reported by the medical examiner that the patient had passed away. She had called to see if a company representative could come and check the device as she wanted to see if the patient was having a seizure or cardiac issue at the time of death. It was explained that the vns did not have those capabilities. It was confirmed the generator was explanted and the lead was clipped in the chest pocked, but not removed from the neck. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
The explanted vns generator was received by the manufacturer for analysis" was inadvertently left off of the initial mfr. Report. (b)(4).
 
Event Description
The medical examiner's office was contacted and it was reported the cause of the patient's death was hypertensive cardio vascular disease. It was also noted the patient did have a "bad heart". When speaking to the medical examiner directly, she stated this was the only conclusion she was able to draw based on the limited amount of information available. She explained the patient was quite decomposed and she was unable to assess the brain tissue to see if there had been any seizure activity which may have caused or contributed to the death. The explanted vns generator was received by the manufacturer for analysis and analysis was completed. The vns generator demonstrated the device was able to provide the expected level of output current during testing and the diagnostic values were as expected. There were no performance or any other types of adverse conditions found with the generator. The programming history database was reviewed. There were no anomalies found within the data available.
 
Event Description
The returned lead had analysis completed and approved. A small portion of the lead was returned measuring approximately 130mm. The condition of the returned lead portion was consistent with those that typically exist following an explant procedure. No obvious anomalies were noted in the returned lead portion. An evaluation could not be performed on the portion of the lead not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6593008

 6 
 on: May 20, 2019, 10:05:38 PM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Event Date 03/01/2008
Event Type  Malfunction   
Event Description
Reporter indicated that patient was in the hospital for three weeks and in that time an external defibrillator was used. Subsequent diagnostics testing revealed high lead impedance, indicating a lead malfunction. Patient later underwent a full revision surgery. Explanted lead and generator were returned to manufacturer, however, that analysis is not yet complete.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1037190

 7 
 on: May 20, 2019, 10:05:02 PM 
Started by dennis100 - Last post by dennis100
Lot Number 567565
Device Problem Magnet failure
Event Date 01/16/2008
Event Type  Malfunction   
Event Description
Reporter indicated that a magnet was used to inhibit stimulation during external defibrillation. Following the event, the magnet was reported to not stop seizures like it had in the past. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810749

 8 
 on: May 20, 2019, 10:03:18 PM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 04/11/2017
Event Type  Malfunction   
Event Description
It was originally reported by the physician's office that they had performed a vns adjustment and received the message "programmed current not being delivered". The nurse stated diagnostics were not performed, but she did note that no high impedance message was observed. It was later reported the patient began to experience tachypnea and labored breathing after the office visit. It was first occurring every 5 minutes and then it was occurring every 20 minutes, so they were unable to tell if is was occurring with vns stimulation. The device history record for the lead and the generator were reviewed and it was found both devices had passed all testing prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported by the nurse that the patient did not begin to experience the labored breathing until the settings were changed to an output current of 2ma. It was also explained through the conversation that the patient had been programmed to just 0. 125ma back in february and was programmed from 1ma to 1. 5ma just 2 weeks prior to being bumped up to 2ma. It was explained to the nurse that when programming the patient up by a half step as opposed to just a quarter step, they will received a "warning" message stating so, but that it does not indicate there is anything wrong with the device. It was also explained that since the patient is new to vns, the fast titration may be the cause of the labored breathing and they could try going back down in settings a little and giving the patient a couple extra weeks to acclimate to settings. It was explained by the nurse that a different physician had recommended the same thing. The nurse stated she would provide this feed back to the physician. No additional relevant information has been received to date.
 
Event Description
The physician sent a fax stating that the patient's labored breathing and the shortness of breath were both related to vns. The neurologist opted to lower the patient's output current in an attempt to resolve the symptoms and the patient was able to tolerate the new settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6553128

 9 
 on: May 20, 2019, 10:01:44 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/02/2012
Event Type  Injury   
Event Description
Clinic notes indicated that a patient went into cardiac arrest with associated respiratory arrest when he was given opioid pain medication shortly after his initial vns implant surgery. The medical team was administering the medication every 6 hours after surgery had occurred. Around midnight on the date of surgery, the staff noticed that the patient's breathing pattern had changed, leading to the cardiac arrest. An ambulance was called, and the patient was defibrillated. The physician concluded that the cardiorespiratory arrest was an adverse reaction to the pain medication and not caused by the placement of the vns. Clinic notes from later clinic visits indicated that the device was functioning properly. No additional relevant information has been received to date.
 
Event Description
The physician reported that the opioid painkillers were administered to the patient prophylactically. The physician also noted that the patient was non-verbal, so it could not be determined if or where the patient was experiencing post-surgical pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820596

 10 
 on: May 20, 2019, 09:59:02 PM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that the patient had three breakthrough seizures, but the physician had also stopped the patient's vimpat. Diagnostics were performed, which confirmed that the device was functioning properly. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's tie-down was protruding at the neck incision. It was stated that the patient has not had efficacy possibly from the lead being placed too low also causing side effects. It was alleged that the patient started feeling a burning sensation and vibrating in the throat with auto-stimulation. It was thought that the increase in seizures could have caused the patient to have more autostimulations than usual, which caused the burning/vibrating in the neck area. The device was then disabled in may due to the burning sensation and vibrating in throat. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the device was likely disabled around (b)(6) as the patient was seen in the emu at this time. No additional or relevant information has been received to date.
 
Event Description
Information was received indicating that the patient is scheduled for a full replacement. Surgery is likely but has not been completed to date. No additional or relevant information has been received to date.
 
Event Description
The patient underwent a full explant. It was stated that x-rays were reviewed and revealed that the device was too low and the electrodes did not appear even on the nerve the explanted devices have not been received for analysis to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566145

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