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Author Topic: Unintentional Settings  (Read 217127 times)
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dennis100
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« Reply #1890 on: April 21, 2019, 03:13:38 AM »

Model Number MODEL 250
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic history, it was identified that patient's vns system was found programmed to incorrect settings on (b)(6) 2015. An interrupted system diagnostic test is suspected, which may have caused an unintended change in device settings during the previous office visit. Attempts for additional relevant information have been unsuccessful to date. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6105584
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dennis100
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« Reply #1891 on: April 21, 2019, 11:22:30 PM »

Model Number MODEL 250
Event Date 04/20/2016
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic history, it was identified that an unintended change in device settings occurred on (b)(6) 2016. There is no evidence of the settings been corrected on the same date; the patient most likely left the office visit with a duty cycle less than 2% (30 sec on time and 60 min off time). It was identified that an interrupted system diagnostic test occurred that could have caused an unintended change in device settings during that office visit on (b)(6) 2016. No patient adverse events were reported.
 
Event Description
Further information from the physician indicated that this patient's generator was replaced on (b)(6) 2016. Patient was then seen again in clinic in (b)(6) 2016 (which was the last visit until now), where his settings were adjusted. No further details on the settings could be provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6089018
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dennis100
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« Reply #1892 on: April 21, 2019, 11:23:17 PM »

Model Number MODEL 250
Event Date 09/16/2014
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic history, it was identified that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2014. The settings were not corrected on the same date. The review of the manufacturing records confirmed that the programming computer passed all functional tests prior to the distribution. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6078479
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dennis100
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« Reply #1893 on: April 22, 2019, 12:17:41 AM »

Model Number MODEL 250
Event Date 09/24/2014
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic history, it was identified that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2014. The settings were not corrected on the same date. The device settings were ok on (b)(6) 2015. The review of the manufacturing records confirmed that the programming computer passed all functional tests prior to the distribution. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6078543
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dennis100
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« Reply #1894 on: April 24, 2019, 12:54:03 AM »

Model Number MODEL 250
Device Problems Computer Software Problem; Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2012
Event Type  Malfunction   
Event Description
It was reported that on (b)(6) 2016 a vns patient experienced an increase in seizures and a decrease in perception 4 years ago in 2012. She had to escalate back up on levetiracetam though it is unclear if this is making any impact. " the device was stated it was not near end of service. The physician noted specifically that ¿ her current output is not consistent with her set parameters and that after 12 years of stimulation she was past the battery life¿ indicating he believes the battery may currently be depleting. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Generator replacement surgery occurred. The generator was received for analysis and was completed 01/18/2017. The report of low battery was not confirmed. During the analysis, there was no indication from the device that an end of service condition existed. The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. 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. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Follow-up from the physician provided that the intended output setting was 1. 25 milliamps, however it was started to be 1. 0 milliamps. The device settings were currently reported to be 1. 5 milliamps. The results of the most recent systems diagnostics were within normal limits. The patient¿s increase in seizures was not worse, but was the same as before she had vns, at 3-4 per week.
 
Event Description
Further follow-up from the physician provided that the current output that was not consistent with the set parameters was observed after an interrogation check. The physician stated that it was believed the battery was near end of life. The that the incorrect output current after interrogation of device settings provides evidence that the cause of the incorrect output current was due to a faulted systems diagnostic test, and may be related to the increase in seizures and decrease in perception experienced by the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6189981
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dennis100
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« Reply #1895 on: May 05, 2019, 12:45:08 AM »

Model Number MODEL 250
Event Date 06/16/2005
Event Type  Malfunction   
Manufacturer Narrative
Corrected data: the initial report inadvertently listed the wrong software version number.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
A computer software error was observed when reviewing a pt's programming history. On (b)(6) 2005, a faulted system diagnostics test was observed, after which the pt was not interrogated. The pt's next recorded visit was on (b)(6) 2006, during which the pt's settings were indicative of interrupted system diagnostics. The pt's settings were not corrected at the visit. The pt's settings were still unchanged at the next visit on (b)(6) 2006. The settings were changed between (b)(6) 2006, but the date of the change is unk per the programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324815
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dennis100
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« Reply #1896 on: May 11, 2019, 12:35:45 AM »

Model Number 105
Device Problem Energy Output Problem
Event Date 03/15/2019
Event Type  Malfunction   
Event Description
Physician reported that the programming system used on a patient was freezing and causing the patient's settings to spontaneously change to lower than programmed. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8555605
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dennis100
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« Reply #1897 on: May 11, 2019, 12:36:24 AM »

Model Number 102
Device Problem Energy Output Problem
Event Date 03/11/2019
Event Type  Malfunction   
Event Description
It was reported that patient had an explant due to battery depletion but prior to the patient¿s off time was 60 min when it has been programed to 5 min off per the nurse. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8487214
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dennis100
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« Reply #1898 on: May 14, 2019, 12:59:56 AM »

Model Number 104
Device Problem Energy Output Problem
Event Date 04/05/2018
Event Type  Malfunction   
Event Description
It was reported that a patient¿s generator was found to be disabled and not delivering current due to a wand reset. The patient experienced coughing when the device was re-enabled. Per the reporter, this had occurred previously with the patient¿s generator and when the device was re-enabled the patient experienced coughing as well. It was reported that an error code 382 was seen which corresponds to the message seen for a variety of disablement causes, and there was no known intentional reset of the patient's device. Reportedly, the patient has had no falls or potential trauma to his chest, there has been no surgery of any kind which could have resulted in the reset, and no one else interrogated his vns device. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. A review of exported programming data confirmed that the patient¿s generator had been reset with an estimated date of (b)(6) 2018. After a system diagnostics test was performed, the device performed as expected. An additional interrogation on (b)(6) 2019 indicated another reset occurred as the estimated restart time was on (b)(6) 2019. There were no issues with lead impedance values or any anomalies with battery voltage in the available data. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8492020&pc=LYJ
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dennis100
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« Reply #1899 on: May 18, 2019, 12:45:56 AM »

Device Problem Energy Output To Patient Tissue Incorrect
Event Type  Malfunction   
Event Description
It was reported from the patient¿s treating physician that they believed an airport scanner had turned off a patient¿s vns generator. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6593226
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dennis100
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« Reply #1900 on: May 27, 2019, 11:06:38 PM »

Model Number 250
Device Problems Computer Software Problem; Energy Output To Patient Tissue Incorrect
Event Date 11/15/2016
Event Type  Malfunction   
Event Description
A physician reported that a patient was having an increase in seizures and when he came into the office, his vns device was found to be programmed off for an unknown reason. No warning messages were received on the programming software. No additional relevant information has been received to date.
 
Event Description
Information was received that the patient's vns device was turned back on and the patient's seizure activity has decreased. Programming data was received from the physician however the patient's serial number is not known at this time so the data could not be reviewed for the patient's device.
 
Event Description
The patient's product information was received so the programming data could be reviewed for the patient. It was found after a programming history review that there was a failed diagnostic test which resulted in the patient's device being inadvertently disabled. The disablement of the device is what led to the increase in seizures for the patient since the disablement was not caught until a later date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6658075
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dennis100
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« Reply #1901 on: May 27, 2019, 11:08:32 PM »

Model Number 102R
Device Problem Communication or Transmission Problem
Event Date 05/31/2017
Event Type  Injury   
Event Description
It was reported from the patient¿s full vns replacement surgery that, preoperatively, the patient had pain from a shocking sensation with device diagnostics and lost consciousness for about 30 seconds. The patient¿s behavior was described ¿as if he was having a seizure. ¿ the full diagnostic reading could not be collected due to the poor tolerability of the diagnostic test. It was later clarified that the patient¿s behavior during diagnostic test was that he was ¿incoherent for about 30 seconds¿ but soon recovered. The vns was not disabled prior to surgery. During dissection of the old leads, the patient experienced an episode of asystole while the nerve was being manipulated. The device was disabled at that time to remove it was a variable. The placement of the new leads and generator occurred without incident. The patient¿s explanted lead and generator were reported to have been discarded. Therefore, device return is not expected. Review of the programming history from the surgery showed that a faulted system diagnostic test occurred preoperatively that led to an unintended change of settings. These settings were not resolved until the generator was disabled. No additional pertinent information has been received to date.
 
Event Description
Follow up with the patient¿s surgeon showed that the preoperative ¿episode¿ experienced during the vns diagnostic test represented syncope with the patient being unresponsive for a few seconds. The surgeon knew of no other contributing factors besides vns stimulation. The patient was stated to have fully recovered without intervention and that the episode was assessed to not represent a serious injury. To date, not further pertinent information has been received regarding the intraoperative asystole.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6652801
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dennis100
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« Reply #1902 on: May 30, 2019, 06:11:33 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/17/2017
Event Type  Injury   
Event Description
It was reported that the patient's output current turned to zero due to an unknown reason. The patient had previously been programmed to 1. 5 ma. Because of the loss in therapy, the patient experienced an increase in seizures. The patient was programmed back on. As the patient's generator is a model 102, it is susceptible to programming anomalies that may occur during programming or diagnostics as addressed in the device's labeling. Therefore this can reasonably be attributed to a programming anomaly. Per labeling, the patient's device should be interrogated at the end of each appointment in order to prevent the patient from leaving with unintended settings caused by a programming anomaly. No further relevant information has been received to date.
 
Event Description
It was reported that when the patient's generator was found to be programmed off, the patient's seizure rate was the same as baseline. After the generator was reprogrammed on, the patient's seizure rate improved, but the rate was not as good as before the vns was unintentionally disabled. Review of the programming history found that a programming anomaly occurred on (b)(6) 2017 that left the patient's device unintentionally disabled. The physician did not perform a final interrogation and the disabled output current wasn't corrected until (b)(6) 2017. No further relevant information was received to date.
 
Event Description
It was determined that the programming anomaly event described in supplemental mdr 1 was the anomaly that caused the patient's increased in seizures. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6641856
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dennis100
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« Reply #1903 on: June 08, 2019, 05:16:44 AM »

Model Number 102
Device Problem Energy Output Problem
Event Type  Malfunction   
Event Description
It was reported that a patient's settings were changed unexpectedly and the device was found to be off. It was unclear how settings were changed. It was noted that the patient had been traveling since her last visit and the office was unsure if this may have contributed to the setting change. It was specified that the office was not having any issues with the programming system. The patient's device was left off as the patient had been seizure free. Diagnostics were confirmed to be within normal limits. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8607225
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dennis100
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« Reply #1904 on: June 08, 2019, 05:17:34 AM »

Model Number 102
Device Problem Energy Output Problem
Event Date 02/13/2019
Event Type  Malfunction   
Event Description
It was reported that patient had an appointment, the device was interrogated and the normal mode output current was set to 0. 00 ma while the magnet mode current was still set to 2. 00 ma. The np stated that the patient's device was not turned off at the time of the event in february. The facility cannot determine whether the patient's device has been turned off since february, they have decided to start the patient back up at lower levels and titrate the patient up slowly. She stated that diagnostics were run and were within normal limits. Programming history was reviewed and had settings from february and april appointments. It is seen that the last event in february was a programming event to 1. 75ma and when the patient came in april the settings were at 0ma. There is no indication form the settings of a faulted diagnostic test that may have unintentionally changed settings. There is a two month gap where the patient may have potentially been seen by a different physician and programmed to these settings however this needs to be confirmed. Other than the note anomaly above, no other anomalies were noted. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8599052
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dennis100
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« Reply #1905 on: June 09, 2019, 12:53:33 AM »

Model Number 103
Device Problem Energy Output Problem
Event Date 09/20/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was interrogated and found to be disabled, unintentionally. It was reported that once discovered the patient's generator was able to be programmed back on without any difficulty or malfunction. The disablement was described by the representative as all of the settings being programmed to 0. The patient's generator was checked in (b)(6) 2019 and everything was reportedly operating as expected with the intentionally programmed settings. On (b)(6) 2019 the generator was found to be disabled again and re-programmed back on without difficulty. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8638576
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dennis100
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« Reply #1906 on: June 12, 2019, 02:36:46 AM »

Model Number 106
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported that the physician interrogated the patient's device during an office visit. The device's auto stimulation mode output current was found set to 3. 25ma however the physician believed that a different output current had been programmed at the previous visit. It was noted that this was the second time a suspected change in settings had occurred. A review of the internal programming history database found that the device had been intentionally programmed to the reported settings at one time. However it was unclear when the physician found what were believed to be incorrect settings. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6914115
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dennis100
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« Reply #1907 on: June 13, 2019, 03:07:41 AM »

Model Number MODEL 250
Event Date 02/06/2006
Event Type  Malfunction   
Event Description
Review of the patient's programming history was performed. It was observed that a faulted system diagnostic test occurred on (b)(6) 2006 which changed the settings to 1ma, 20hz, 500 microseconds, 30 seconds on, 60 minutes off; magnet: 1 ma, 500 microseconds, 30 seconds on, when settings of 1 ma, 20 hz, 250 microseconds, 30 seconds on, 5 minutes off; magnet: 1. 25 ma, 250 microseconds, 60 seconds on were intended. A final interrogation was performed, but the settings were not corrected on the same office visit. The settings were corrected on (b)(6) 2006. 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=3459681
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dennis100
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« Reply #1908 on: July 05, 2019, 09:48:50 PM »

Model Number MODEL 3000
Device Problem Computer Software Problem
Event Date 03/12/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The physician provided clinic notes which mentioned that at an office visit, the programmer was "malfunctioning," and therefore the patient could not be programmed. At the next appointment, it was discovered that the patient's generator had been unintentionally programmed to 0ma output current. The physician believed that the device was at eos because of the device's age and the fact that the output current was at 0ma. It was also mentioned that it was possible, but unlikely, that the patient came in contact with a strong magnet during recent travels which turned the system off. It was noted that the physician was able to program the patient's system back to 1. 5 ma normal mode output current and 2. 5 ma magnet mode output current at this appointment. Additionally, it was noted that the patient lost perception of stimulation for "the past couple months", which would have put the start date right around the time of the noted programmer "malfunction. " no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8691878
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dennis100
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« Reply #1909 on: July 11, 2019, 12:23:23 AM »

Model Number 103
Device Problem Energy Output Problem
Event Date 07/02/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Report received that a patient's generator was interrogated in the clinic. An error message was received on the programmer stating "the pulse generator is disabled due to a wand reset". The provider then used another programmer to interrogate the device where it was found that all the output currents were set to 0ma. Further information was received from the provider that there were no actions taken before the generator was interrogated. It was also reported that it was not possible that another provider could have disabled the device prior to the disablement being seen in the clinic. There was no programming history available for review and no additional data has been reviewed to date. The device history record was reviewed and showed that the generator passed all quality inspections and electrical testing prior to being released for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726092
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« Reply #1910 on: July 11, 2019, 12:24:17 AM »

Model Number 102R
Device Problem Energy Output Problem
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported through clinic notes that a patient's model 102r device was unexpectedly found off on (b)(6) 2019. The patient hadn't been programmed since (b)(6) 2018 and per the physician's notes wasn't turned off and the parents denied seeing anyone between (b)(6) 2018 and (b)(6) 2019. The patient had an increase in seizures in (b)(6) 2018 which he believed may be related to the vns being disabled. The patient's vns was turned back on. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8745033
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« Reply #1911 on: July 14, 2019, 04:12:03 AM »

Model Number 106
Device Problem Energy Output Problem
Event Date 08/06/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in seizures and upon interrogation of his device it was found that the output currents were disabled. It was reported that clinical notes from the last office visit at 6/29 showed that the vns was on. The physician did not recall any error messages upon interrogation, and was able to perform diagnostics which were normal and confirmed the battery was ok. No relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7838618
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« Reply #1912 on: July 20, 2019, 10:17:09 PM »

Model Number MODEL 250
Event Date 11/23/2011
Event Type  Malfunction   
Event Description
During analysis of the received generator, it was noted that the as received programmed settings were indicative that a faulted system diagnostics test had occurred and the patient may have been at unintended settings. The generator had been replaced due to normal end of service. Review of the programming history available to the manufacturer found that two faulted system diagnostic tests occurred on (b)(6) 2011. One of these faulted tests likely resulted in the change in settings. A final interrogation was not performed. No adverse events have been reported as a result of the change in settings.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2569026
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« Reply #1913 on: July 23, 2019, 12:46:39 AM »

Model Number 250
Event Date 04/12/2008
Event Type  Malfunction   
Event Description
During the review of the pt's programming history, it was noted that a faulted system diagnostic test on (b)(6) 2008 altered the pt's settings unintentionally. The settings were not corrected until (b)(6) 2008.
 
Manufacturer Narrative
Analysis of programing history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2354815
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« Reply #1914 on: July 26, 2019, 12:49:56 AM »

Model Number MODEL 3000
Device Problem Computer Software Problem
Event Date 12/17/2018
Event Type  Malfunction   
Manufacturer Narrative
Suspect device software version: version 1. 0. 2. 4.
 
Event Description
It was reported that the patient's generator settings were changed to unintended settings by the programming system software. A review of the programming history found that the reported unintentional settings were programmed as part of a "standard protocol. " this is consistent with information from the nurse practitioner, who indicated that during the initial interrogation the system showed guided programming, which is not a feature available on the model 106 generator the patient's implanted with. It was reported that the patient's settings were programmed as intended before leaving the dosing appointment. No other programming events were marked as standard protocol. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242411
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« Reply #1915 on: July 30, 2019, 10:15:25 AM »

Model Number 106
Device Problem Energy Output Problem
Event Date 01/15/2019
Event Type  Malfunction   
Event Description
It was reported that the patient¿s settings had been interrogated and found to be disabled. The patient¿s device was programmed back on. Programming history was attempted to be reviewed, however no data has been received. The device history record was reviewed for the generator and no anomalies were seen. No further information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8318120
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« Reply #1916 on: August 09, 2019, 11:24:07 PM »

Model Number 102
Device Problem Energy Output Problem
Event Date 05/01/2019
Event Type  Malfunction   
Event Description
The patient reported that their vns stopped working in (b)(6) 2019. The patient mentioned that they knew the device had stopped working because they experienced an increase in seizures. The patient went in to have the vns checked, and the patient reports that the device was programmed off due to event that he states is a "common occurrence for his generator model number. " additionally, the patient's physician assistant informed the livanova sales representative that they did see the vns change to 0ma output current, however no further details were provided. Further follow up has been performed to the physician's assistant's office, however no response has been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8767384
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« Reply #1917 on: August 09, 2019, 11:24:46 PM »

Model Number 1000
Device Problem Energy Output Problem
Event Date 05/26/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's m1000 vns generator had an unexpected settings change when interrogated. It was stated that an error message was observed indicating that the stimulation was not being provided. The company representative clicked "ok" and dismissed the message. The output current was shown as 0. 75 ma, magnet as 1. 00 ma, and autostim was disabled. The patient's previous settings were 0. 875 ma for autostim. The company representative turned on the autostim, but was unable to verify the heartbeat. The company representative ended the session and re-interrogated the vns. The autostim now showed as programmed to 0. 875 ma. Based on a review the tablet data received to date, the time of the reboot of the device, which resulted in disablement of settings, was identified. No other issues were identified in the decoder. The tablet data from the company representative present at the patient's implant surgery was reviewed later and no reboots or anomalies were identified. Internal testing is being performed as to the root cause of the event. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8777018
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dennis100
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« Reply #1918 on: August 09, 2019, 11:25:38 PM »

Model Number 1000
Device Problem Energy Output Problem
Event Date 05/22/2019
Event Type  Malfunction   
Event Description
It was reported on that the patient's vns had been turned on with a 10% duty cycle on date of implant. Sensing was turned on, but autostimulation output current was set to 0 ma. When the patient was next seen, the autostimulation detection was turned off. It was subsequently turned back on and reprogrammed. Today, at the end of the session, the patient was noted to be in off time of 100% of the time per the session report pie chart. Normal mode stimulation in the pie chart was noted as <1%, even though parameters had been at 10% duty cycle since implant advanced interrogation had been used to interrogate. Diagnostics were fine and magnet swipes registered and were felt by the patient. The parents of the patient then stated that the vns hadn't been working since implant and then from (b)(6) (intermediate appointment) and onwards. Later that day, the patient's father reported that the patient's device was turned off 4 hours after the appointment while the patient was in the car as the patient was no longer feeling magnet stimulation. Follow-up with the attending representative who attended the surgery, found that he hadn't been aware of any problems at date of implant. Review of the patient's programming data found that the generator had been reset due to error code 6 - "flash access violation. " the times of reset were reviewed and it was determined that the devices reset due to error code 6 within 24 hours of being programmed 3 times. The parents and patient reported that there had been nothing unusual occurring at the time when these occurred. During the first reset, the patient was still in the hospital, during the second reset, the patient was likely watching tv with his family and the third reset the patient was in the car. Approximately two weeks after the 3rd device reset, a field visit was conducted by livanova engineers for further data gathering. With the assistance of the physician, the patient's device was re-enabled at approximately noon. The device was still on at 4:30 pm. However, the patient and mother reported that the patient's device disabled that night while they were watching tv. During the field visit, extensive questioning found that the patient had not been exposed to any unexpected/unusual electrical equipment/situations. The patient's sensing was turned off the next morning. A week later, it was determined that the patient's device had not reset since the sensing was turned off. The generator's manufacturing device history records were reviewed. The generator passed final functional and quality specifications prior to release. Further investigation is underway but at the time of this report potential causes of this event include a defective microcontroller wafer lot, an unpublished errata from the component manufacturer, hardware bugs sensitive to alignment of code blocks, or a gap in the workaround for a known errata. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8787082
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dennis100
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« Reply #1919 on: August 09, 2019, 11:26:26 PM »

Model Number 1000
Device Problem Energy Output Problem
Event Date 05/29/2019
Event Type  Malfunction   
Event Description
It was reported by the physician that the patient had come in 3 times with the device off due to error code 6 - flash access violation, and he didn't know why. Patient could still feel the magnet but autostimulation was off. Further information was received outlining the following events: physician said he had turned the patient's device on originally on (b)(6), and patient left the office with the generator programmed to deliver normal, magnet, and autostimulation. When the patient came back to follow up on (b)(6), the device was off with sensing. Patient's wife denied patient having any imaging done (ie: mri) in that time frame. She said the patient stopped feeling the magnet swipe the day before coming into clinic (around (b)(6)). The physician said he ran systems diagnostics, magnet diagnostics, and generator diagnostics and all "checked out within normal limits. " he then set the device on to previous settings. On (b)(6), the patient's wife reported that the patient doesn't feel the magnet swipe anymore (he could feel it the days before) and doesn't think the device is working again. Wife reported that there was a magnetic frame in their above-ground pool and that the patient had been swimming over the weekend. The device was found to be reset/disabled again on (b)(6) 2019 and turned back on. The patient came in on (b)(6) 2019, and the device had not reset. The patient has stayed out of their above-ground pool, which they believed may have caused the device to shut off. The data was reviewed and error code 6 was identified. Beyond the error code 6 reboot, no obvious anomalies in the data were observed. Livanova engineers participated in a field visit on (b)(6) 2019, to obtain data. Reset time stamps were provided to the patient and his wife. They could not remember what happened prior to the (b)(6) reboot, but would have been asleep or sitting in bed at the time of all of the reboots. Internal data reviewed showed that the patient had logged 117 magnet swipes between (b)(6), with only 19 completed magnet stimulations. The patient indicated that he was feeling seizures coming on in that time period and was swiping the magnet as much as possible, which aligned with the data. At this visit, it was observed that the device again was disabled. As a result, the physician elected to leave tachycardia detection disabled. He increased normal and magnet stimulation output currents. Review of the extended data indicated that a reboot occurred on (b)(6), a few minutes after 10 am, resulting in the tachycardia detection disablement. The (b)(6), clinic visit ended around 10 am, so the device likely rebooted during the visit. The physician denied intentionally disabling the generator. The generator's manufacturing device history records were reviewed. The generator passed final functional and quality specifications prior to release. Further investigation is underway but at the time of this report potential causes of this event include a defective microcontroller wafer lot, an unpublished errata from the component manufacturer, hardware bugs sensitive to alignment of code blocks, or a gap in the work around for a known errata. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8787296
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