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Author Topic: Unintentional Settings  (Read 217131 times)
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dennis100
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« on: July 19, 2017, 02:07:43 AM »

Model Number 250
Event Date 12/01/2010
Event Type Malfunction
Event Description
It was initially reported by the treating neurologist that the pt's settings appeared to be at unintentional settings, which appeared to be due to an interrupted system diagnostic test. The current physician changed the settings and could not confirm the previous physician, so no further details were available on the issue. Later, the pt reported having shortness of breath, so the physician opted to temporarily disable for a week and begin a gradual titration. Diagnostics were said to have been performed, which were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1968650
« Last Edit: July 19, 2017, 08:59:05 AM by dennis100 » Logged
dennis100
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« Reply #1 on: July 19, 2017, 02:08:29 AM »

Model Number MODEL 250
Event Date 11/09/2015
Event Type Malfunction
Event Description
It was reported that the vns patient's device was tested recently and the patient began coughing and gagging due to device stimulation delivered from the diagnostic test. The patient's device had previously been disabled and believed to have remained programmed off following the office visit. Additional information was received stating that the patient's device was evaluated by another physician on (b)(6) 2015 as the patient had been experiencing left jaw pain and the device was found to be programmed on. It is possible that an interrupted system diagnostic test occurred during the previous office visit that caused an unintended change in device settings. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5294773
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dennis100
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« Reply #2 on: July 19, 2017, 02:09:19 AM »

Model Number MODEL 250
Event Date 11/12/2009
Event Type Malfunction
Event Description
During review of programming history, it was noted that an interrupted system diagnostic test occurred that caused an unintended change in device settings. The settings were not corrected at the time of the event. No adverse events have been reported as a result of this.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3545944
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dennis100
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« Reply #3 on: July 19, 2017, 02:10:02 AM »

Model Number 250
Event Date 07/08/2010
Event Type Malfunction
Event Description
It was reported that during generator revision surgery, an interrupted systems diagnostic test occurred resulting in the patient being programmed to 01/20/500/30/60. The nurse practitioner did not perform a final interrogation and did not notice the setting change. The change in settings resulted in the patient vomiting, gagging and having nausea with stimulation. The patient followed up with the nurse practitioner who then noted the setting change. The nurse practitioner programmed the device off and the issues resolved. Good faith attempts to obtain a copy of the programming history to verify the interrupted systems test are current being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1804747
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dennis100
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« Reply #4 on: July 19, 2017, 02:11:40 AM »

Model Number 250
Event Date 12/01/2010
Event Type  Malfunction   
Manufacturer Narrative
The treating physician notified the manufacturer regarding the software anomaly.
 
Event Description
It was reported by a neurologist that she found the patient's presented settings are different than what was intended during an office visit in (b)(6) 2011. The settings appeared to be indicative of a faulted systems diagnostic test. It is most likely that the test did not complete, resulting in a change in the patient's settings. There were no reports of any patient adverse events as a result. The patient's settings were corrected on (b)(6) 2011 and the physician was instructed to perform final interrogations at the end of each office visit to ensure the settings are as intended.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2074893
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dennis100
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« Reply #5 on: July 19, 2017, 02:12:42 AM »

Model Number MODEL 250
Event Date 06/27/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the vns patient was having intolerable voice issues on an hourly basis. The patient¿s device was interrogated and found to be programmed to settings indicative of an interrupted system diagnostic test. The patient¿s device was tested during an office visit the previous day, but the system diagnostic test had to be interrupted because the test was too painful for the patient to tolerate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3952700
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dennis100
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« Reply #6 on: July 19, 2017, 02:13:51 AM »

Model Number 250
Event Date 08/18/2009
Event Type Malfunction
Event Description
It was reported that the vns patient was seen for a follow up appointment in (b)(6) 2010 and reported that he was feeling that the device was stimulating erratically over the past 3 months or so. The patient also reported experiencing an increase in seizure activity, below the pre-vns baseline over the past 3 months. The patient was no longer in the office when the physician called the manufacturer, however, he did state that a system diagnostic test was performed which revealed normal device function. The physician requested that a mfr representative be present for the patient's next follow up appointment to test the device. At the subsequent follow up visit, when the device was interrogated, the off time was noted to be 60 minutes off. The device settings upon interrogation were 1ma/20hz/500usec/30sec/60mins, which are settings indicative of an interrupted system diagnostic test. The device settings were re-programmed to the intended settings at that time. The data from the physicians hand held was sent to manufacturer for review, where it was observed in (b)(6) 2009 there was a faulted system diagnostic test and no final interrogation was done to ensure the device was set to the intended settings. The next interrogation was in the beginning of (b)(6) 2010, but the settings were not changed at that time. The settings were finally corrected on (b)(6) 2010.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1638700
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dennis100
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« Reply #7 on: July 19, 2017, 02:14:35 AM »

Model Number MODEL 250
Event Date 08/21/2007
Event Type  Malfunction   
Event Description
Reporter indicated that the physician was having some difficulty with programming. The physician reported that the pt felt "shocking" at the electrode site when she walked past a magnetic board. The physician reported that he had checked to confirm the magnet mode was at 0ma; however, review of programming history shows that during an interrupted systems diagnostic test the magnet mode output current had been inadvertently set to 1ma. Although a final interrogation was performed which showed this setting, the physician did not reprogram the generator at that time. Another systems diagnostic test was performed and was within normal limits. At the next office visit the magnet mode output current was reprogrammed to 0ma.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=958702
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dennis100
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« Reply #8 on: July 19, 2017, 02:15:54 AM »

Model Number MODEL 250
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A request for a battery life calculation was received by the manufacturer for a patient¿s generator, and the settings were provided were those indicative of an interrupted system diagnostic test. Review of the available programming and diagnostic history available in the in-house database for the device did not reveal any anomalies; however, the history available in house ends on (b)(6) 2011. Attempts for additional information will be made.
 
Event Description
Additional information was received stating that the neurologist did not make any programming changes to the vns patient's device settings as the patient was doing well, despite being programmed to a low duty cycle (30 seconds on, and 60 minutes off).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3662478
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dennis100
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« Reply #9 on: July 19, 2017, 02:16:52 AM »

Model Number 250
Event Date 02/22/2011
Event Type  Malfunction   
Event Description
Following a generator's explant, it was received for product analysis by the mfr at the settings of 1 ma/20 hz/500 microsec/30 sec/60 min and 1 ma/30 sec/500 microsec. These settings are indicative of an interrupted system diagnostic test. A search of the mfr's programming history database showed last known settings to be on (b)(6) 2009, which were 0. 75 ma/20 hz/130 microsec/14 sec/0. 3 min and 0. 75 ma/30 sec/500 microsec. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2041422
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dennis100
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« Reply #10 on: July 19, 2017, 02:44:27 AM »

Model Number MODEL 250
Event Date 06/07/2011
Event Type Malfunction
Event Description
During review of the in-house programming/diagnostic history database, it was observed that 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 device was not 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; therefore, the settings were not corrected prior to the patient leaving the office. 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=3548769
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dennis100
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« Reply #11 on: July 19, 2017, 02:45:09 AM »

Model Number MODEL 250
Event Date 06/28/2013
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) 2013, 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) 2013. The physician corrected the settings; however, the device off time and magnet on time were not corrected. The device was not interrogated prior to the patient leaving the office on (b)(6) 2013 as recommended by device manufacturer to ensure the device is at the correct settings; therefore the settings were not corrected prior to the patient leaving the office. 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=3550408
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dennis100
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« Reply #12 on: July 19, 2017, 02:46:16 AM »

Model Number MODEL 250
Event Date 04/11/2013
Event Type Malfunction
Event Description
During review of the in-house programming/diagnostic history database, it was observed that on office visit on (b)(6) 2013 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2013. The settings found were indicative of a generator diagnostic test which occurred on (b)(6) 2013. The device was not interrogated prior to the patient leaving the office on (b)(6) 2013 as recommended by device manufacturer to ensure the device is at the correct settings; therefore, the settings were not corrected prior to the patient leaving the office. The settings were corrected on (b)(6) 2013. 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=3548110
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dennis100
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« Reply #13 on: July 19, 2017, 02:48:20 AM »

Model Number MODEL 250
Event Date 11/05/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
During review of programming history, it was noted that an interrupted system diagnostic test occurred that caused an unintended change in device settings. The settings were not corrected at the time of the event. No adverse events have been reported as a result of this.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3547610
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dennis100
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« Reply #14 on: July 19, 2017, 02:50:00 AM »

Model Number MODEL 250
Event Date 03/02/2011
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 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 device was not 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; therefore, the settings were not corrected prior to the patient leaving the office. The settings were not corrected until (b)(6) 2011; however, the device off time was never corrected. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3546992
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dennis100
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« Reply #15 on: July 19, 2017, 02:51:34 AM »

Model Number MODEL 250
Event Date 01/12/2012
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 on office visit on (b)(6) 2012 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2012. It was noted that a faulted diagnostic test occurred on (b)(6) 2012 and the device was not 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; therefore, the settings were not corrected prior to the patient leaving the office. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3546983
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dennis100
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« Reply #16 on: July 19, 2017, 02:53:29 AM »

Model Number MODEL 250
Event Date 03/13/2007
Event Type Malfunction
Event Description
During review of programming history, it was noted that an interrupted system diagnostic test occurred that caused an unintended change in device settings. The settings were not corrected at the time of the event. No adverse events have been reported as a result of this.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3546742
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dennis100
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« Reply #17 on: July 19, 2017, 02:55:20 AM »

Model Number MODEL 250
Event Date 05/07/2008
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) 2008, 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) 2008. 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) 2008 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=3546543
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dennis100
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« Reply #18 on: July 19, 2017, 02:56:53 AM »

Model Number MODEL 250
Event Date 06/01/2010
Event Type Malfunction
Event Description
A review of programming and diagnostic data was performed. On (b)(6) 2010 a faulted system diagnostics test occurred and no final interrogation took place. On the patient's next visit, (b)(6) 2010, it was observed that the patient's settings had been changed due to this faulted system diagnostics test to the incorrect settings.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3545961
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dennis100
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« Reply #19 on: July 19, 2017, 02:59:04 AM »

Model Number MODEL 250
Event Type Malfunction
Event Description
It was reported that upon device interrogation the patient's settings were different than what were previously programmed. The physician reported that the device on time was low and the device off time was 60 seconds indicating that a faulted diagnostic test likely occurred. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4427194
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« Reply #20 on: July 19, 2017, 03:00:26 AM »

Model Number 102
Device Problem Energy output to patient tissue incorrect
Event Date 02/07/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during an interrogation, a patient's device was identified to be mysteriously programmed off. The nurse who identified that the patient's device was off did not believe any other physicians had done it and had no prior knowledge of the device being programmed off purposely when the event was identified. A review of the available programming history did not identify a cause for the event and showed that the device had previously operated as intended. A review of the manufacturing records verified that the generator had passed all inspections and was manufactured accordingly prior to release for distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6405491
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dennis100
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« Reply #21 on: July 19, 2017, 03:01:59 AM »

Model Number 101
Event Date 01/01/2008
Event Type Malfunction
Event Description
Reporter indicated that pt's pulse generator was interrogated and it was discovered that "settings were not what they should be. " good faith attempts are currently being made to obtain further info.

Manufacturer Narrative
Device malfunction suspected, but did not cause or contributed to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992269
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dennis100
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« Reply #22 on: July 19, 2017, 03:04:30 AM »

Model Number 250
Event Date 11/01/2010
Event Type Malfunction
Event Description
It was reported that the initial interrogation of a pt's vns at a routine office visit showed settings that were indicative of a faulted diagnostics test. The site indicated that a systems diagnostics test was performed at the last office visit that was likely not followed by a final interrogation. The pt's settings were then corrected after the unintended settings were discovered. No adverse events were reported as a result of the loss of therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2188683
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dennis100
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« Reply #23 on: July 19, 2017, 03:05:56 AM »

Model Number 250
Event Date 04/10/2006
Event Type Malfunction
Event Description
While reviewing the programming history available to the manufacturer, it was noted that a faulted diagnostics test occurred and caused the patient's settings to change unintentionally. The change in settings was not found and corrected until the next office visit. 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=2189231
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dennis100
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« Reply #24 on: July 19, 2017, 03:07:19 AM »

Model Number MODEL 250
Event Date 02/20/2006
Event Type Malfunction
Event Description
During review of programming history, it was noted that an interrupted system diagnostic test occurred on (b)(6) 2006 that caused an unintended change in device settings. The settings were not all corrected at the time of the event. (the magnet on time was not corrected. ) no adverse events have been reported as a result of this.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3550025
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dennis100
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« Reply #25 on: July 19, 2017, 03:24:09 AM »

Model Number 250
Event Date 01/01/2011
Event Type Malfunction
Event Description
It was reported that upon interrogation of the pt's vns generator prior to surgery, it was found that the settings were indicative that a faulted diagnostics test had occurred. This resulted in the pt being set at unintended settings. It is unk when the faulted diagnostics test occurred. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102410
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« Reply #26 on: July 19, 2017, 03:25:41 AM »

Model Number 250
Event Date 04/14/2005
Event Type Malfunction
Event Description
While reviewing the vns programming history available to the manufacturer, it was noted that a faulted diagnostics test occurred that resulted in a change in the programming settings. The physician interrogated the vns after the change in settings, however, he did not correct the change until the next visit. No adverse events have been reported as a result of the event.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092854
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« Reply #27 on: July 19, 2017, 03:27:31 AM »

Model Number 250
Event Date 01/01/2008
Event Type Malfunction
Event Description
During manufacturer review of a vns patient's programming history, it was identified that on (b)(6) 2010, the patient was interrogated and found to have vns settings of 0. 75ma/20hz/500pw/30 sec on/60 min off. The 60 minutes off is a default setting for an interrupted systems diagnostics test. The patient was immediately programmed to 5 minutes off time on (b)(6) 2010. There is no data prior to (b)(6) 2010 so it is unknown when the programming anomaly occurred, or what vns programming system was used. The faulted test is suspected to have occurred with a different vns programming system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2187460
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« Reply #28 on: July 19, 2017, 03:29:13 AM »

Model Number 250
Event Date 04/06/2011
Event Type Malfunction
Event Description
It was initially reported by the physician that a patient had come into an appointment at unintended settings. The physician reported that at the previous appointment that system diagnostics were run and there was no final interrogation. The physician would not provide the patient information citing (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2101698
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« Reply #29 on: July 19, 2017, 03:31:07 AM »

Model Number MODEL 250
Event Date 01/01/2006
Event Type  Malfunction   
Event Description
During a review of a pt's programming history available in the mfr's programming history database, it was found that the pt presented settings different than what was intended during an office visit on (b)(6) 2006. The settings most likely occurred due to a faulted systems diagnostic test sometime between (b)(6) 2004 and (b)(6) 2006, no specific date was identified. On (b)(6) 2006, output current and off time were corrected to 1. 5ma and 1. 8 mins. There were no reports of any pt adverse events as a result. The physician has been instructed to perform final interrogations at the end of each office visit to ensure the settings are as intended. On (b)(6) 2004 - interrogate - output current: 1. 5 ma, signal frequency: 20 hz, pulse width: 250 usec, on time: 30 seconds, off time: 1. 8 mins, magnet output current: 1. 75ma, pulse width: 250 usec, on time: 60 seconds. On (b)(6) 2006 - interrogate - output current: 0 ma, signal frequency: 20 hz, pulse width: 250 usec, on time: 30 seconds, off time: 3 mins, magnet output current: 1. 75ma, pulse width: 250 usec, on time: 60 seconds. On (b)(6) 2006 - program - output current: 1. 5 ma, signal frequency: 20 hz, pulse width: 250 usec, on time: 30 seconds, off time: 3 mins, magnet output current: 1. 75ma, pulse width: 250 usec, on time: 60 seconds.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092832
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