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dennis100
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« Reply #30 on: July 19, 2017, 03:34:14 AM »

Model Number 250
Event Date 04/26/2006
Event Type  Malfunction   
Event Description
While reviewing the programming history available to the mfr for the pt's vns generator, it was noted that the pt's vns settings on (b)(6) 2006 were indicative of a faulted diagnostics test that likely occurred at the previous visit on (b)(6) 2006. The pt likely left the previous visit at unintended settings that were not corrected until the next visit. A final interrogation was not performed as recommended to verify that the pt was at the intended settings. No adverse events have been reported as a result of the anomaly.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117709
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dennis100
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« Reply #31 on: July 19, 2017, 03:36:00 AM »

Model Number 250
Event Date 11/28/2007
Event Type Malfunction
Event Description
While reviewing the programming history available to the mfr for the pt's vns generator, it was noted that the pt's vns settings on (b)(6) 2008 were indicative of a faulted diagnostics test that likely occurred at the previous visit on (b)(6) 2007. The pt likely left the previous visit at unintended settings that were not corrected until the next visit. A final interrogation was not performed as recommended to verify that the pt was at the intended settings. No adverse events have been reported as a result of the anomaly.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117694
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dennis100
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« Reply #32 on: July 19, 2017, 03:37:40 AM »

Model Number 250
Event Date 05/18/2007
Event Type Malfunction
Event Description
While reviewing the programming history for the generator noted in manufacturer report # 1644487-2011-01010, it was noted that the patient was found to be at settings indicative of a faulted diagnostics test upon initial interrogation of the patient's vns generator. At the previous office visit on (b)(6) 2007, it was noted that a faulted generator diagnostics test occurred that likely resulted in the unintended settings change. A final interrogation was not performed. The unintended settings were corrected at the next visit. No adverse events have been reported as a result of the change in settings.

Manufacturer Narrative
Method: analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117660
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dennis100
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« Reply #33 on: July 19, 2017, 03:39:33 AM »

Model Number 250
Event Date 06/24/2010
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
It was stated in a patient's clinical information on (b)(6) 2011, that his current settings were indicative of an interrupted diagnostic test. A review of the manufacturer's programming history database confirmed that on (b)(6) 2010, a faulted system diagnostic test changed the patient's settings. The patient's settings were partially corrected, although the off time was left at altered settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2118868
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dennis100
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« Reply #34 on: July 19, 2017, 03:53:21 AM »

Model Number 250
Event Date 01/01/2011
Event Type Malfunction
Event Description
During analysis of a vns generator returned due to end of service, it was found that the as rec'd programmed settings were indicative of a faulted diagnostics test. F/u with the surgeon's office found that no note of any interrogation or diagnostics was noted on the operative report from the day of replacement surgery. This indicates that a faulted diagnostics test likely occurred prior to this date which may have resulted in the pt not receiving the intended therapy. Attempts for add'l programming history are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2118114
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dennis100
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« Reply #35 on: July 19, 2017, 03:54:38 AM »

Model Number MODEL 250
Event Date 01/16/2011
Event Type Malfunction
Event Description
During mfr review of a pt's vns programming history, it was noted a faulted systems diagnostics test occurred which changed the pt's settings from 1. 75ma/20hz/250pw/14 seconds on/1. 8 mins off to 1ma/20hz/500pw/30 seconds on/60 mins off. The pt's vns was reinterrogated, but no settings were changed after the faulted test. The physician has since been informed of the need to perform final interrogations to ensure that vns settings are as intended.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092838
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dennis100
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« Reply #36 on: July 19, 2017, 03:55:58 AM »

Model Number 250
Event Date 11/09/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contributed to a death or serious injury.

Event Description
It was reported to mfr that the vns pt's device setting were not what was expected when the device was interrogated at a follow up visit. Attempts to obtain add'l info from the physician have been made, but have been unsuccessful to date. The programming history from the handheld is expected to be returned to mfr for review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=964352
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dennis100
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« Reply #37 on: July 19, 2017, 03:57:34 AM »

Model Number MODEL 250
Event Date 09/11/2009
Event Type Malfunction
Event Description
A review of programming and diagnostic data was performed. On (b)(6) 2009, a faulted system diagnostics test changed the generator parameters to unintended settings. The changed settings were first observed on (b)(4) 2010. The settings were not corrected until (b)(6) 2011.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3552226
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dennis100
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« Reply #38 on: July 19, 2017, 03:59:16 AM »

Model Number MODEL 250
Event Date 09/17/2012
Event Type Malfunction
Event Description
During review of the periodic programming history, it was discovered that a faulted diagnostic test occurred on (b)(6) 2013 and programmed the device to unintended settings. The device was interrogated prior to leaving the office; however, the settings were not corrected until (b)(6) 2013.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551616
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dennis100
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« Reply #39 on: July 19, 2017, 06:02:48 AM »

Model Number MODEL 250
Event Date 12/15/2012
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) 2010 the patient's settings were different than what were programmed at the same office visit. The settings found were indicative of a generator diagnostic test which occurred 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=3548778
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dennis100
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« Reply #40 on: July 19, 2017, 06:04:32 AM »

Model Number 250
Event Date 12/15/2005
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
While reviewing the programming history available to the manufacturer for the patient's vns generator, it was found that a faulted diagnostics test likely occurred that resulted in a change in the patient's settings. The faulted settings were corrected at the next visit. No adverse events were reported as a result of the change in settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2175230
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dennis100
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« Reply #41 on: July 19, 2017, 06:05:15 AM »

Model Number MODEL 250
Event Date 07/27/2006
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the vns pt's programming history, it was noted that a faulted diagnostics test occurred on the day of implant that resulted in the pt being set to unintended settings. The physician interrogated the generator following the faulted test however he did not correct the unintended settings. The settings were corrected by the neurologist at the next office visit. No adverse events were reported as a result of the change in settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2154191
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dennis100
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« Reply #42 on: July 19, 2017, 06:05:55 AM »

Model Number 250
Event Type  Malfunction   
Event Description
During review of internal programming history, it was noted that an interrupted test occurred on an unk date and another interrupted when they were seen in clinic on (b)(6) 2010 and unk if they left the office at unintended therapy that date. The pt came into clinic on (b)(6) 2010 and found to be at interrupted test settings 0/20/500/30/60 instead of their intended therapy of 1. 5/30/500/30/5. On the same visit, after interrogation, another system test faulted and no interrogation was performed. Therefore, unk if the pt left the office at unintended therapy.
 
Manufacturer Narrative
Review of programming history confirmed event unk date event occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2172223
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dennis100
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« Reply #43 on: July 19, 2017, 08:24:06 AM »

Model Number 250
Event Date 04/20/2009
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
During the review of the programming history, a programming anomaly was observed. The generator was returned to the mfr set to settings which do not appear to be typical for the pt given the history and known duty cycle. This could potentially be a cross-programming issue or interruption in diagnostics, however, due to lack of info, this cannot be confirmed. Attempts for further info have been unsuccessful to date.

Event Description
A programming history review was performed which found that the changed settings were due to a faulted system diagnostic test. On (b)(6) 2009, a faulted system diagnostic test was performed and a final interrogation was not performed on the vns device afterwards. The patient was next seen (b)(6) 2009 and found to be programmed to different settings upon initial interrogation. Although most of the patient's settings were adjusted at this visit, the off time was not changed from 60 minutes leaving the patient with an inefficacious duty cycle. The most current programming information available, from (b)(6) 2011, shows the patient is still set to 60 minutes off time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2161109
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dennis100
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« Reply #44 on: July 19, 2017, 08:25:28 AM »

Model Number 250
Event Date 05/28/2006
Event Type Malfunction
Manufacturer Narrative
Method - analysis of programming history.

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 likely occurred due to a faulted systems diagnostic test between (b)(6) 2006 and (b)(6) 2006. After the programming anomaly was identified, it was not completely corrected until (b)(6) 2006 where off time was corrected from 60 minutes to 5 minutes. 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) 2006, program - output current: 2. 25 ma, signal frequency: 30 hz, pulse width: 250 usec, on time: 30 seconds, off time: 1. 1 minutes, magnet output current: 2. 50 ma, pulse width: 250 usec, on time: 60 seconds. On (b)(6) 2006, system diagnostics - communication = ok, output status = ok, lead impedance = ok, dcdc = 2, eri = no. On (b)(6) 2006, interrogate - output current: 0 ma, signal frequency: 30 hz, pulse width: 500 usec, on time: 30 seconds, off time: 60 minutes, magnet output current: 0 ma, pulse width: 500 usec, on time: 30 seconds. On (b)(6) 2006, program - output current: 0. 25 ma, signal frequency: 30 hz, pulse width: 500 usec, on time: 30 seconds, off time: 60 minutes, magnet output current: 0. 25 ma, pulse width: 500 usec, on time: 30 seconds. On (b)(6) 2006, interrogate - output current: 0. 25 ma, signal frequency: 30 hz, pulse width: 500 usec, on time: 30 seconds, off time: 60 minutes, magnet output current: 0. 25 ma, pulse width: 500 usec, on time: 30 seconds. On (b)(6) 2006, program - output current: 0. 5 ma, signal frequency: 30 hz, pulse width: 250 usec, on time: 30 seconds, off time: 5 minutes, magnet output current: 0. 75 ma, pulse width: 500 usec, on time: 30 seconds.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2185666
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dennis100
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« Reply #45 on: July 19, 2017, 08:26:48 AM »

Model Number 250
Event Date 06/09/2008
Event Type Malfunction
Event Description
During review of the vns patient's programming history available to the manufacturer, it was noted that a faulted systems diagnostics test occurred that resulted in a change of the patient's settings. An interrogation was not performed following the diagnostics test. The unintended settings were corrected at the next visit. No adverse events have been reported as a result of the faulted diagnostics.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2189245
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dennis100
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« Reply #46 on: July 19, 2017, 08:28:26 AM »

Model Number 250
Event Date 10/30/2006
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2011, a manufacturer's clinical investigator reviewed the vns pt's programming history and found two faulted diagnostic tests that occurred (b)(6) 2006, where the physician did not perform a final interrogation afterwards. The pt presented at their next appointment on (b)(6) 2007, with the incorrect settings of 0/20/500/30/0. 8 due to the faulted diagnostics from the prior visit. The pt was then programmed to higher settings. If additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2101954
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dennis100
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« Reply #47 on: July 19, 2017, 08:29:52 AM »

Model Number 250
Event Date 04/29/2011
Event Type Malfunction
Manufacturer Narrative
Analysis of limited programming history provided by the physician.

Event Description
On (b)(6) 2011, a vns treating physician reported that the vns patient came in for a scheduled appointment and after interrogation it was noticed that the patient was not at the settings they were previously programmed to at their last visit. The patient's settings were at 1. 0/20/500/30/60 with magnet at 1. 25/60, but they should have been at 2. 0/30/500/30/1. 8 with magnet at 2. 25/60/500. The patient lives at a group home and that the physician assistant there has his own programming system and does not feel that he needs additional training for the device. It was discussed that possibly the physician's assistant at the group home may have ran a systems diagnostics that faulted which could have resulted in the patient's incorrect settings; however, the physician assistant at the patient's group home would have even interrogated the patient. The physician states that she did run a final interrogation during the patient's last appointment and the patient had left with the correct settings. The consultant is going to obtain a copy of the physician's programming history for review. When additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2109773
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dennis100
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« Reply #48 on: July 19, 2017, 08:31:24 AM »

Model Number 250
Event Date 08/12/2009
Event Type Malfunction
Event Description
This event was reported in error. Further review of the available programming history revealed that, while a faulted system diagnostic test did occur, it was identified and corrected within a few minutes. The date of the faulted system diagnostic test was (b)(6)2009. There was no risk to the patient and no loss of therapy as a result of the faulted system diagnostic test.

Manufacturer Narrative
Analysis of programming history.

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) 2009. The settings occurred due to a faulted systems diagnostic test sometimes between (b)(6) 2009, no specific date was identified. The pulse width and off time were corrected on (b)(6) 2009 to 250 u seconds and 3 minutes. 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) 2009 - program - output current: 1 ma, signal frequency: 20 hz, pulse width: 250 usec, on time: 30 seconds, off time: 5 minutes, magnet output current: 1. 25ma, pulse width: 250 usec, on time: 30 seconds. On (b)(6) 2009 - interrogate - output current: 1 ma, signal frequency: 20 hz, pulse width: 500 usec, on time: 30 seconds, off time: 60 minutes, magnet output current: 1ma, pulse width: 500 usec, on time: 30 seconds. On (b)(6) 2009 - program - output current: 1 ma, signal frequency: 20 hz, pulse width: 250 usec, on time: 30 seconds, off time: 3 minutes. Magnet output current: 1. 25ma, pulse width: 500 usec, on time: 30 seconds.

Manufacturer Narrative
(b)(4):this issue was reported in error. The incorrect settings were corrected within a few minutes of the faulted system diagnsotic test.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2094617
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« Reply #49 on: July 19, 2017, 08:32:49 AM »

Model Number 250
Event Date 03/03/2006
Event Type Malfunction
Manufacturer Narrative
Analysis of programming.

Event Description
It was noted through review of a patient's programming history that a vns patient was set to unintended settings. The patient was implanted on (b)(6), 2001 and upon review of the patient's programming history it was noted that the patient settings were found to be at 1/20/500/30/60 on (b)(6) 2006 which correspond to a programming anomaly. At the moment good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2189238
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dennis100
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« Reply #50 on: July 19, 2017, 08:34:12 AM »

Model Number 250
Event Date 11/13/2005
Event Type Malfunction
Event Description
During mfr review of a pt's vns programming history, it was identified that a faulted systems diagnostics test caused the vns settings to change to systems diagnostics default settings of 1ma/20hz/500 pulsewidth/30 sec on/60 min off on (b)(6) 2005. The settings were not corrected until (b)(6) 2005. The physician has been trained to always perform a final vns interrogation to verify settings before the pt leaves the office.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107767
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dennis100
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« Reply #51 on: July 19, 2017, 08:35:26 AM »

Model Number 250
Event Date 11/19/2007
Event Type Malfunction
Event Description
Manufacturer review of a pt's vns programming history revealed a pt's vns settings were found to be at 0ma at an office visit on (b)(6) 2007. The settings were adjusted back to intended parameters on (b)(6) 2007. A system's diagnostics test was performed at a previous office visit on (b)(6) 2007 and faulted, followed by a successful system's diagnostics test, but no final interrogation occurred to confirm the settings. It is suspected the faulted system's diagnostics test caused the output current to reset to 0ma, which is a default setting for an interrupted system's diagnostics test.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2177518
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« Reply #52 on: July 19, 2017, 08:36:32 AM »

Model Number 250
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history. Although, a faulted systems diagnostics test was not noted during the review of programming history, it is suspected a faulted test occurred due to the 60 minutes off time setting, which is a default setting for a faulted systems diagnostics test.

Event Description
Reporter indicated a patient's vns settings were unintended at an office visit, as the off time was 60 minutes. The patient was new to the reporter and the settings were pre-existing to the office visit. The settings were adjusted by the reporter. Review of available vns programming history for the patient did not identify any anomalies, but nearly five years of recent history is missing. Sixty minutes off is a default setting for a faulted systems diagnostics test; it is suspected a faulted test occurred previously with an unknown vns computer which caused the settings to change.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2175221
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« Reply #53 on: July 19, 2017, 08:37:35 AM »

Model Number 250
Event Date 04/26/2011
Event Type Malfunction
Event Description
It was reported by a nurse through a company rep that a vns pt was seen in clinic and noted that the pt's pulse width parameter had been changed, but pt had not been reprogrammed by the hosp, making the event of unk cause. At the moment, good faith attempts to obtain additional info regarding the event are still underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107383
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« Reply #54 on: July 19, 2017, 08:38:44 AM »

Model Number 250
Event Date 08/12/2003
Event Type Malfunction
Event Description
During the review of the patient's programming history database, it was noted that a faulted system diagnostic test unintentionally re-programmed the patient's generator during the initial implant surgery on (b)(6) 2003. The settings were not fully corrected until (b)(6) 2003.

Manufacturer Narrative
Method - analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2175204
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« Reply #55 on: July 19, 2017, 08:39:49 AM »

Model Number 250
Event Date 07/01/2009
Event Type Malfunction
Event Description
Manufacturer review of a vns pt's programming history revealed that a faulted systems diagnostics test occurred on (b)(6) 2009 which caused the vns settings to change and the output current to be set to 0ma. Md. At the next office visit on (b)(6) 2009, the settings were adjusted back to the intended settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2177517
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« Reply #56 on: July 19, 2017, 08:40:58 AM »

Model Number 250
Event Date 05/03/2010
Event Type Malfunction
Event Description
A review of the patient's programming history was performed on (b)(6) 2012. During this review it was observed that a faulted system diagnostic test first occurred on (b)(6) 2010, which resulted in a change to the patient's settings. The off time was left at 60 minutes and the magnet was left at 1. 0ma. It was previously reported by the physician that on (b)(6) 2010, the patient's off time was 5 minutes, however review of the available history indicates that the off time was 60 minutes as it had not previously been corrected. Additionally 3 faulted test occurred on (b)(6) 2011, which resulted in a change to the patient's setting. Again, the patient left at un-intended settings as the off time was left at 60minutes. The off time was not corrected until (b)(6) 2011. The magnet appears to have been intentionally enabled.

Event Description
It was initially reported that a patient was having painful stimulation, although the pain was not present with every stimulation. System diagnostics revealed proper device function at this time and the patient's settings were said to be 2 ma/20 hz/250 microsec/30 sec/5 min. Furthermore, when a company representative followed up with the site diagnostics on (b)(6) 2010 showed all systems to be properly functioning. It was on this date that the doctor described receiving an error message, but the exact detail on the message was not known at this time. The representative met with the patient and doctor and found the patient's settings to be 1 ma/20 hz/500 microsec/30 sec/60min. System diagnostic testing on this day showed proper device function. It was explained to the doctor that these settings indicated a faulted diagnostic test. Attempts for more information have been unsuccessful to date.

Manufacturer Narrative
Method: analysis of programming history (if applicable).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102227
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« Reply #57 on: July 19, 2017, 08:50:39 AM »

Model Number MODEL 250
Event Date 06/22/2010
Event Type Malfunction
Event Description
It was reported from a review of the pt's programming history that the pt's settings were altered on (b)(6) 2010. The report stated that the generator was interrogated on (b)(6) 2010 and found to be at faulted systems diagnostic settings. The pt's programming history in the in-house database was available from (b)(6) 2007 (the date of implant) to (b)(6) 2010. A review of the programming history confirmed that a faulted diagnostic test occurred on (b)(6) 2010 which resulted in the pt's setting change. The pt's programming errors were not resolved prior to the pt leaving the physician's office.

Manufacturer Narrative
Method: review of programming/device diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2313503
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« Reply #58 on: July 19, 2017, 08:51:50 AM »

Model Number 106
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 01/23/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician did not intentional disable and from their recollection no error message internal investigation shows that the physician likely encountered the "errant invalid parameter values " error message, which forced the programming to 0 ma. The device was programmed without the physician's intention. While the device could have been programmed back by the physician, there is not a logged attempt to reprogram it back to original settings on the same day.
 
Event Description
The patient's device was interrogated and found to be disabled. The device was previously programmed to therapeutic level. Programming history was reviewed and it shows that the device was disabled. The device was interrogated again and settings were observed to be at 0 ma. But there was no programming event after that to enable the device by the physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7529963
« Last Edit: September 11, 2018, 06:10:32 AM by dennis100 » Logged
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« Reply #59 on: July 19, 2017, 08:52:53 AM »

Model Number 250
Event Date 10/22/2009
Event Type Malfunction
Event Description
Manufacturer review of a pt's vns programming history identified that a faulted systems diagnostics test occurred on (b)(6) 2009 which caused the settings to change. There was no final interrogation performed to verify settings. The settings were corrected on (b)(6) 2009.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2101949
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