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Author Topic: Unintentional Settings  (Read 195912 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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