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dennis100
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« Reply #480 on: January 21, 2019, 11:08:23 AM »

Model Number MODEL 250
Event Date 08/16/2012
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2012 the patient's settings were different than what were programmed at the same office visit. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2012. The physician corrected the settings; however, the magnet on time was not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2012 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the magnet on time back to previous setting. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3943629
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dennis100
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« Reply #481 on: January 21, 2019, 11:09:15 AM »

Model Number MODEL 250
Event Date 11/20/2009
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation at an office visit on (b)(6) 2009 the patient¿s settings found were indicative of a faulted diagnostic test. The patient was implanted (b)(6) 2009. Based on the settings listed in programming/diagnostic history database the faulted system diagnostics test occurred on the day of implant, which caused the settings to change. Not all settings were corrected; however, and the magnet output current was at 1 ma. The patient is a depression patient and it is recommended that the magnet output current remain "off". No adverse events were reported. The settings were corrected on (b)(6) 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942225
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dennis100
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« Reply #482 on: January 22, 2019, 04:48:20 AM »

Model Number MODEL 250
Event Date 02/04/2008
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2008. The physician corrected the settings; however, the frequency and magnet on time were not corrected. A generator diagnostic test was performed during an office visit on 06/09/2008 which changed frequency and magnet on time back to settings prior to the interrupted system diagnostic test. No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3936374
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dennis100
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« Reply #483 on: January 23, 2019, 01:58:34 AM »

Model Number 103
Event Date 05/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was experiencing an increase in seizures. The neurologist planned to give the patient new medication. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The physician¿s office reported that after the patient was started back on medication, the patient has not been herself and had increased seizures. There are a lot of health issues. When the vns was checked previously, all diagnostics were okay.
 
Manufacturer Narrative

Event Description
The nurse at the treating physician¿s office reported that they recently performed vns programming changes, but they have not worked. The vns is felt to not be working. She reported that the magnet did not work the morning of (b)(6) 2014 and resultantly the patient had a seizure. She said that they feel the magnet is not working, and the patient has also been having more seizures since may. The patient went about 6-8 weeks since december with only 4 seizures and now has increased to having seizures every couple of days, to every day and one day she had two seizures. The patient was actually admitted recently to the hospital due to cluster of seizures. They are trying to get her as controlled as possible and have gone through medication changes as well. It is unclear what the cause of the increased seizures is but the medical staff is wondering if the generator is nearing end of service. The relationship of the increased seizures to pre-vns seizure frequency level was unknown by the nurse. Cyberonics labeling indicates that vns magnet therapy is an adjunctive therapy and not all patients benefit from its use.
 
Event Description
The patient had a follow-up appointment at which time the medications were adjusted, in addition to the magnet off time from 5 minutes to 3 minutes. Diagnostics were performed to check the device function and no anomalies were noted. The group staff was re-educated on magnet usage.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3916647
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dennis100
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« Reply #484 on: January 24, 2019, 03:53:52 AM »

Model Number MODEL 250
Event Date 09/13/2006
Event Type  Malfunction   
Event Description
The physician reported that the patient began to deteriorate after about a month and a half without magnetic activation. The physician noted that the output current has been pushed up to the patient's pre-op dose of 2. 5ma. The patient was reported to be tolerating the increase well and is now improved.
 
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2006. The physician corrected the settings; however, the magnet output current was not corrected. No patient adverse events were reported.
 
Manufacturer Narrative
\ the information included in follow-up mfr. Report #1 was inadvertently reported as this was not related to the report. Please disregard that information as it does not pertain to this reported event.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3905146
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dennis100
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« Reply #485 on: January 24, 2019, 03:54:48 AM »

Model Number 103
Event Date 07/29/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient had several grand mal seizures and that her magnet was not aborting her seizures.
 
Event Description
It was reported that the patient was referred to a new epileptologist due to an increase in seizures. It is unknown whether the increase is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4040075
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dennis100
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« Reply #486 on: January 25, 2019, 09:17:14 AM »

Model Number MODEL 250
Event Date 07/23/2014
Event Type  Malfunction   
Event Description
This event is a known issue with software version 8. 0 and rior model 250 software, and v10. 0 software is the same software as v8. 0 on a tablet interface. This issue has been corrected with v8. 1 software. In these events, multiple magnet activation times being displayed on the same line when viewing patient magnet history with vns programming software. The issue is related to a local array being mis-declared as a static variable within the programming software which is triggered when viewing patient magnet activation history which spans the time period before and after a generator total operating time rollover.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that the physician assistant's handheld had a dark screen. The power button was pressed which illuminated the screen briefly, but the handheld screen returned dark. During troubleshooting the company representative identified that the handheld did not show small icons on the bottom of the database screen. The physician assistant was provided a new programming tablet. The handheld is expected to be returned, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027185
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dennis100
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« Reply #487 on: January 25, 2019, 09:18:00 AM »

Model Number MODEL 250
Event Date 01/30/2014
Event Type  No Answer Provided   
Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on (b)(4) 2014. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Electronic submission of this report was not possible due to a problem with the mfr's software used for emdr submissions. Method: review of programming history performed.
 
Event Description
It was reported that during the pt's office visit that the pt's magnet activations were not displaying correctly. It was reported that the pt only had one magnet swipe recently, with only a total of 8 registering. However, for the one activation on (b)(6) 2014, the tablet magnet history was displaying 15 times. The total swipes registered displayed as 86. A copy of the physician's programming tablet data was obtained. Magnet history coincides with only one swipe registering on (b)(6) 2014 with no indication of multiple magnet activations. It was observed that total operating time rollover of the device occurred between the last appointment on (b)(6) 2012 and (b)(6) 2014. As a result, the magnet history on the tablet was showing 15 activations on (b)(6) 2014, because no other activations were available in the history due to rollover. The 15 most recent magnet activations stored within the generators memory span the time period before/after the rollover event are displayed and since there was only one swipe, 15 activations were displayed on the tablet on (b)(6) 2014. It is known that the device reed switch can be activated by several consumer devices/other devices that have magnetic field (i. E. Multiple accidental magnet swipes, etc. ). However, attempts for further info from the physician were unsuccessful.
 
Event Description
This report is to correct the initial mfr. Report that was inadvertently sent with a duplicate report #. The report was submitted via emdr on 08/21/2014 regarding a handheld screen issue and was inadvertenly sent with report # 1644487-2014-02046. Please correct that initial report to reflect the new number attached to this follow-up report.
 
Manufacturer Narrative
This report is to correct the mfr. Report # of the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027546
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dennis100
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« Reply #488 on: January 30, 2019, 09:06:08 AM »

Model Number MODEL 250
Event Date 06/19/2006
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that on office visit on (b)(6) 2006 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2006. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2006. The physician corrected the settings; however, the device pulse width, off time and magnet on time were not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2006 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the settings back to previous settings. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4064332
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dennis100
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« Reply #489 on: January 31, 2019, 02:11:35 AM »

Model Number MODEL 250
Event Date 07/06/2008
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6), 2014 during a review of programming history, it was observed that a system diagnostic test occurred on (b)(6) 2008 which resulted in a setting change. The settings change was noticed during that appointment but the magnet output was not corrected at that visit.
 
Manufacturer Narrative
Corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4054760
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dennis100
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« Reply #490 on: January 31, 2019, 02:12:15 AM »

Model Number MODEL 250
Event Date 09/07/2010
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2010 the patient's settings were different than what were programmed at the same office visit. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2010. The physician corrected the settings; however, the magnet on time was not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2010 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the magnet on time back to the previous setting. No patient adverse events were reported.
 
Manufacturer Narrative
Age at time of event or date of birth; corrected data: the previously submitted mdr inadvertently provided an incorrect patient age and date of birth. This report is being submitted to correct this data.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4205862
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dennis100
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« Reply #491 on: January 31, 2019, 02:12:47 AM »

Model Number MODEL 250
Event Date 04/20/2011
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2014 during a review of programming history, it was observed that a faulted system diagnostic test occurred on (b)(6) 2011 which resulted in a settings change. While attempting to correct the settings, a partial programming event occurred which was corrected but the settings were still not fully corrected when they were changed as a result of the faulted system diagnostic test. The magnet output was not programmed back off as intended.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4059021
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dennis100
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« Reply #492 on: January 31, 2019, 02:13:22 AM »

Model Number MODEL 250
Event Date 06/05/2002
Event Type  Malfunction   
Event Description
On (b)(6) 2014 during a review of programming history, it was observed that a system diagnostic test occurred on (b)(6) 2002 which resulted in a settings change. All settings were not corrected prior to the patient leaving the office visit; the magnet output was inadvertently left at the incorrect settings of output=1ma.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: the initial manufacturer report inadvertently provided an incorrect date for the faulted system diagnostic test.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4061664
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dennis100
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« Reply #493 on: January 31, 2019, 02:13:57 AM »

Model Number MODEL 250
Event Date 07/17/2009
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that on (b)(6) 2009 the patient¿s device programmed settings inadvertently were changed to unintended parameters. The settings found were indicative of a faulted diagnostic test. All settings were corrected except for the magnet on time. The device was not interrogated prior to the patient leaving the office as recommended by device manufacturer to ensure the device is at the correct settings. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4061610
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dennis100
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« Reply #494 on: January 31, 2019, 02:14:36 AM »

Model Number MODEL 250
Event Date 10/13/2010
Event Type  Malfunction   
Manufacturer Narrative
Serial #, corrected data: previously submitted mdr inadvertently did not provide the correct serial number of the suspect device. It is now known. This report is being submitted to correct this data. Lot #, corrected data: previously submitted mdr inadvertently did not include this information. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr inadvertently did not include this information. This report is being submitted to correct this data.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2010, the patient's settings were different than what were programmed at the same office visit. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2010. The physician corrected the settings; however, the magnet on time was not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2010 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the magnet on time back to the previous setting. No patient adverse events were reported.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4063702
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dennis100
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« Reply #495 on: January 31, 2019, 02:15:12 AM »

Model Number MODEL 250
Event Date 09/05/2011
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2011 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2011. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2011. The physician corrected some settings; however, the device pulse width, off time, magnet output current and magnet on time were not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2011 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct these settings back to previous settings. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4063976
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« Reply #496 on: January 31, 2019, 02:15:59 AM »

Model Number MODEL 250
Event Date 11/09/2009
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr indicated that the device was not interrogated prior to the patient leaving the office to ensure the device is at the correct settings; however, an interrogation was performed following the change in settings after which physician re-programmed device settings. Relevant tests/laboratory data, including dates, corrected data: the settings to which the device was reprogrammed on the date of the change in settings was inadvertently omitted from the previous mdr. Lot #, other, corrected data: previously submitted mdr indicated that these items were unknown. They are now known. Name and address, corrected data: previously submitted mdr indicated an incorrect initial reporter. Occupation, corrected data: previously submitted mdr indicated an incorrect initial reporter. Device manufacture date (mo/day/yr), corrected data: previously submitted mdr indicated that this was unknown. They is now known.
 
Event Description
An interrogation was performed following the change in settings after which physician re-programmed device settings; however, not all settings were returned to their previous values.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that a system diagnostic test was performed on (b)(6) 2009. Interrogation after the diagnostic test showed that the settings found were indicative of a faulted diagnostic test. The settings were corrected prior to the patient leaving the clinic, except the magnet on time. The device was not interrogated prior to the patient leaving the office as recommended by device manufacturer to ensure the device is at the correct settings. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4054830
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« Reply #497 on: January 31, 2019, 02:16:40 AM »

Model Number 105
Event Date 10/01/2014
Event Type  Injury   
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.
 
Event Description
It was initially reported that the patient was hospitalized due to seizures. The patient reported that there magnet swiping did not do anything for his seizures.
 
Event Description
On (b)(6) 2014 it was reported that the physician will not provide any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4209421
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« Reply #498 on: February 01, 2019, 12:03:12 PM »

Model Number MODEL 250
Event Date 02/23/2011
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2011. The physician corrected the settings; however, the magnet on time was not corrected. No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4180679
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« Reply #499 on: February 01, 2019, 12:03:50 PM »

Model Number MODEL 250
Event Date 09/30/2009
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2009. The physician corrected the settings; however, the magnet on time was not corrected. No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4183897
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« Reply #500 on: February 01, 2019, 12:05:10 PM »

Model Number MODEL 250
Event Date 01/26/2010
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2010. The physician corrected the settings; however, the magnet on time was not corrected. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4186567
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« Reply #501 on: February 01, 2019, 12:06:03 PM »

Model Number MODEL 250
Event Date 07/22/2010
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2010. The physician corrected the settings; however, the magnet pulse width was not corrected. No patient adverse events were reported.
 
Manufacturer Narrative
(b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4200277
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« Reply #502 on: February 01, 2019, 12:07:06 PM »

Model Number MODEL 250
Event Date 10/05/2010
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2010 the patient's settings were different than what were programmed at the same office visit. The settings found were indicative of a faulted diagnostic test; however, review of system diagnostic testing from office visit on (b)(6) 2010 was within normal limits. The physician corrected the settings; however, the magnet pulse width was not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2010 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the magnet pulse width back to the previous setting. No patient adverse events were reported.
 
Manufacturer Narrative
Date of birth; corrected data: the initial mfr. Report inadvertently reported the wrong date of birth.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4205769
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« Reply #503 on: February 05, 2019, 03:00:21 AM »

Model Number 302-20
Event Date 09/24/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the high impedance was first observed (b)(6) 2014.
 
Event Description
It was reported that the vns patient was sent for x-rays due to concerns with her device lead impedance. X-rays were taken and were reported by the physician to be unremarkable. Follow-up revealed that the patient¿s concerns with lead impedance were due to pain occurring with magnet mode stimulation on-times. The patient¿s magnet output current was subsequently reduced. Patient manipulation or trauma is not believed to have caused or contributed to the event. Follow-up revealed that the patient¿s device was tested and diagnostic results revealed high impedance (dc dc ¿ 6). X-rays dated (b)(6) 2013 and (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block with the images provided. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. 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=4230225
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« Reply #504 on: February 07, 2019, 02:20:57 AM »

Model Number 103
Event Date 11/02/2014
Event Type  Injury   
Event Description
It was reported that the patient was in the icu due to seizures. It was reported that the patient could no longer feel device stimulation and was wondering if the vns was still working. It was reported that the patient experienced three seizures after the noon hour the day prior and that the magnet would not abort the seizures. Further follow-up revealed that the patient was stable and would be seen by a neurologist to have the device checked. The patient was seen the same day by the neurologist at which time it was reported that device diagnostics were within normal limits and the generator was not at end of service. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4287528
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« Reply #505 on: February 07, 2019, 02:21:39 AM »

Model Number 102
Event Date 07/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received indicating that the vns patient experienced 20 seizures back-to-back within a 5 hour period. Magnet mode stimulation was activated but did not help with the patient¿s seizures. The patient had a total of 56 seizures in (b)(6) 2013 with an average of 9 seizures per day. During an office visit on (b)(6) 2013, the patient¿s device showed normal device function and the patient¿s medications were adjusted. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4295509
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dennis100
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« Reply #506 on: February 07, 2019, 09:04:22 PM »

Model Number 103
Event Date 02/08/2014
Event Type  Malfunction   
Event Description
Additional information was received containing the patient's programming, diagnostic, and magnet use history. Review of the magnet usage history showed that the last 15 magnet activations all occurred on 02/08/2014, with no activations occurring since.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that the vns patient¿s device was unable to initiate or inhibits stimulation when using her magnet. It was confirmed that the patient was using the appropriate magnet swipe technique. Attempts for additional relevant 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=4409561
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dennis100
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« Reply #507 on: February 07, 2019, 09:05:06 PM »

Model Number 103
Event Date 12/01/2014
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2014 note that the device magnet output current was previously increased due to an increase in seizures. It is unknown if the increase in seizures was above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4425851
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dennis100
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« Reply #508 on: February 07, 2019, 09:05:37 PM »

Event Date 12/21/2014
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital after experiencing five seizures. It was reported that the magnet stimulation was not aborting seizures and that the device was no longer helping the seizures as much. The patient believes that the vns is not working correctly. No additional relevant information was provided. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4427449
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dennis100
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« Reply #509 on: February 07, 2019, 09:06:15 PM »

Model Number 105
Event Date 12/17/2014
Event Type  Injury   
Event Description
It was reported that the patient had been admitted to the emergency room for seizures, and the emergency room was using the magnet to attempt to abort the seizures. The seizures were not being aborted by the magnet, but the device showed that the magnet swipes were being recorded. Lead impedance of the vns system was within normal limits at 1666 ohms. The patient was reportedly stable at the time of report. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4419262
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