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Author Topic: Unintentional Settings  (Read 130146 times)
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dennis100
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« Reply #1320 on: April 14, 2018, 12:29:26 AM »

Model Number MODEL 250
Event Date 02/07/2007
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
A programming history review was performed which found that a faulted system diagnostic test occurred on (b)(6) 2007 which changed the patient's settings. A final interrogation was not performed and the patient's settings were not adjusted within the same visit. Upon initial interrogation on the following visit, (b)(6) 2007, the faulted settings were seen and adjusted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2991044
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« Reply #1321 on: April 14, 2018, 12:30:05 AM »

Model Number MODEL 250
Event Date 12/16/2005
Event Type  Malfunction   
Event Description
During review of the patient's programming history available in the manufacturer's database, it was observed that a faulted system diagnostic test on (b)(6) 2005 and was not corrected until (b)(6) 2006. A final interrogation was not performed prior to the patient leaving the clinic. Therefore, the programming anomaly was not identified until (b)(6) 2006. No adverse patient events were reported.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2994203
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« Reply #1322 on: April 15, 2018, 12:51:34 AM »

Event Date 01/01/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was discovered during review of the patient's programming history that a programming anomaly occurred that changed the patient's settings on an unknown date. Upon interrogation on (b)(6) 2012 the patient's device the patient was found to be at settings indicative of a faulted system diagnostics test; output=0ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60min/magnet output=0ma/magnet pulse width=500usec/magnet on time=30sec. Only the output current and magnet output current were fixed prior to the patient leaving the visit this date. No adverse events were reported to have occurred due to this settings change. Good faith attempts for additional information from the physician were made but no additional programming history has been received to date.
 
Event Description
On (b)(4) 2013 additional programming history was received from the physician but it did not contain any further information about the faulted system diagnostics test that occurred.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3085844
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« Reply #1323 on: April 16, 2018, 01:30:25 AM »

Model Number 250
Event Type  Malfunction   
Event Description
The patient's vns generator was returned for product analysis after being explanted due to the device nearing battery depletion. Upon receipt of the device, it was noted that the settings were indicative of a faulted diagnostic test. Follow up was performed with the site to see if they had the patient's settings or diagnostic history prior to the explant surgery; however, this information was unavailable. No information was provided. A review of programming history found data up to the year 2010. It is unknown if and when a faulted diagnostic test may have occurred. No other information has been provided.

Manufacturer Narrative
Analysis of programming history.

Manufacturer Narrative
The incorrect date was inadvertently listed on the initial report. The date of the report was (b)(4) 2013 the same date as in manufacturer report number 1644487-2013-01957. The information submitted on the initial report was inadvertently sent, as it is duplicate information to that which was reported in manufacturer report number 1644487-2013-01957. The incorrect aware date was inadvertently listed on the initial report. The aware date should have been (b)(4) 2013, the same aware date as in manufacturer report number 1644487-2013-01957.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3193066
« Last Edit: November 28, 2018, 01:56:46 AM by dennis100 » Logged
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« Reply #1324 on: April 16, 2018, 01:31:07 AM »

Model Number MODEL 250
Event Date 03/08/2011
Event Type  Malfunction   
Event Description
During a review of the patient's programming history, it was found that a faulted system diagnostic test was performed on (b)(6) 2011, which was not followed by a final interrogation. When the patient was next seen on (b)(6) 2011, the patient's settings were different from those the patient was programmed to on (b)(6) 2011 (settings changed to output current = 0ma, frequency = 20 hz, pulse width = 500msec, on time = 30 sec, off time = 60 minutes, magnet output current = 0ma). These settings were corrected on (b)(6) 2011.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3074376
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« Reply #1325 on: April 16, 2018, 01:31:55 AM »

Model Number MODEL 250
Event Date 07/30/2007
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
While reviewing the programming history for the patient's vns generator, it was noted that a computer software error occurred on (b)(6) 2007. The computer software error was caused by faulted systems diagnostics and a final interrogation was not performed to verify the patient's settings on that day. On (b)(6) 2007 the patent's settings was output current= 3. 25 ma/ frequency= 20 hz/ pulse width= 250 ¿sec/on time= 30 sec/off time= 3 min / magnet output current= 1 ma/ on time= 60 sec/ pulse width= 250 ¿sec. During the next office hours of 09/18/2007 the patient¿s vns generator was programmed at output current= 0 ma/ frequency= 20 hz/ pulse width= 250 ¿sec/on time= 30 sec/off time= 3 min / magnet output current= 1 ma/ on time= 60 sec/ pulse width= 250 ¿sec. The vns generator was then programmed back at output current= 3. 25 ma/ frequency= 20 hz/ pulse width= 250 ¿sec/on time= 30 sec/off time= 3 min / magnet output current= 1 ma/ on time= 60 sec/ pulse width= 250 ¿sec.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3074290
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« Reply #1326 on: April 16, 2018, 01:32:30 AM »

Model Number MODEL 250
Event Date 11/28/2010
Event Type  Malfunction   
Manufacturer Narrative
Review of programming history.
 
Event Description
During review of programming history, it was noted that at faulted system diagnostic test occurred on (b)(6) 2010 that changed device settings. Upon interrogation at the next appointment on (b)(6) 2011, the device was found to be off. No adverse events have been reported as a result of this.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3077637
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« Reply #1327 on: April 16, 2018, 01:33:05 AM »

Model Number MODEL 250
Event Date 06/07/2004
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2004 a computer software error was noted while reviewing the vns programming history. A faulted diagnostics was done previously on (b)(6) 2004. On (b)(6) 2004 the patient left the office programmed at output current= 2 ma/ frequency= 20 hz/ pulse width= 250 sec/on time= 30 sec/off time= 1. 8 min / magnet output current= 2. 25 ma/ on time= 60 sec/ pulse width= 250 sec. After the faulted diagnostics the patient was not interrogated and during the next visit the patient was interrogated and was found at settings output current= 1 ma/ frequency= 20 hz/ pulse width= 500 sec/on time= 30 sec/off time= 60 min / magnet output current= 1 ma/ on time= 30 sec/ pulse width= 500 sec. The settings were corrected back in (b)(6) 2004 to ((b)(6) 2004) settings: output current= 2 ma/ frequency= 20 hz/ pulse width= 250 sec/on time= 30 sec/off time= 1. 8 min / magnet output current= 2. 25 ma/ on time= 60 sec/ pulse width= 250 sec.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075380
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« Reply #1328 on: April 16, 2018, 01:33:37 AM »

Event Date 06/16/2008
Event Type  Malfunction   
Event Description
On (b)(6) 2013 review of the patient¿s programming history revealed that on (b)(6) 2008 a faulted system diagnostics test occurred that changed the patient's settings to: output = 1. 0 ma/ frequency = 20 hz/ pulse width = 500 microseconds/ on-time = 30 seconds/ off-time = 60 minutes/ magnet output = 1. 0 ma / magnet pulse width = 500 microseconds/ magnet on time = 30 seconds. At that time the settings were not fully corrected; patient left the office at: output = 1. 50 ma / frequency = 20hz/ pulse width = 500 microseconds/ on-time = 30 seconds/ off-time =60 minutes/ magnet out put = 1. 75 ma/ magnet pulse width = 500 microseconds/ magnet on time = 30 seconds. No adverse events were reported to have occurred due to this settings change.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075472
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« Reply #1329 on: April 16, 2018, 01:34:33 AM »

Model Number MODEL 250
Event Date 06/03/2008
Event Type  Malfunction   
Event Description
During the review of internal programming history, it was observed that a lead test was interrupted on the date of implant (b)(6) 2008, which inadvertently changed the patient's settings to lead test parameters and resulted in the patient experiencing stimulation at 1ma /20 sf /500 pw / 30 seconds on time / 60 minutes off time. The next day the patient's settings were corrected and programmed back off.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075079
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« Reply #1330 on: April 16, 2018, 01:35:04 AM »

Model Number MODEL 250
Event Date 08/10/2007
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
While reviewing the programming history for the patient's vns generator, it was noted that a generator diagnostics was performed on (b)(6) 2007 by the physician's programming computer which resulted in setting the patient's vns generator to unwanted settings. On (b)(6) 2007 the patient's vns generator was set at output current= 3 ma/ frequency= 25 hz/ pulse width= 250 sec/on time= 30 sec/off time= 5 min / magnet output current= 3. 25 ma/ on time= 60 sec/ pulse width= 250 sec. After the generator diagnostics no final interrogation was performed during that office visit and the next interrogation was performed on (b)(6) 2008 which revealed the patient's generator settings to be at output current= 0 ma/ frequency= 30 hz/ pulse width= 500 sec/on time= 30 sec/off time= 5 min / magnet output current= 0 ma/ on time= 60 sec/ pulse width= 500 sec. With the programming history available to the manufacturer the patient was not corrected to the previous settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3073622
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« Reply #1331 on: April 16, 2018, 01:35:39 AM »

Model Number MODEL 250
Event Date 11/19/2008
Event Type  Malfunction   
Event Description
Through review of programming history a defaulted generator diagnostics on (b)(6) 2008 caused the generator to change its settings to undesirable values. On visit (b)(6) 2008, the patient was programmed at settings output current= 1. 75 ma/ frequency= 20 hz/ pulse width= 250 usec/on time= 60 sec/off time= 1. 1 min / magnet output current= 2 ma/ on time= 60 sec/ pulse width= 250 usec. A system diagnostics was then performed on the patient's vns generator which was faulted and changed the patient's settings. No interrogation was performed before the patient left the office. During the next visit on (b)(6) 2008, the patient's vns generator was interrogated and was found at output current= 1 ma/ frequency= 20 hz/ pulse width= 500 usec/on time= 30 sec/off time= 60 min / magnet output current= 1 ma/ on time= 500 sec/ pulse width= 30 usec. The patient's settings were then changed to output current= 2 ma/ frequency= 20 hz/ pulse width= 250 usec/on time= 60 sec/off time= 1. 1 min / magnet output current= 2. 25 ma/ on time= 60 sec/ pulse width= 250 usec.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3071858
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« Reply #1332 on: April 16, 2018, 01:36:14 AM »

Model Number 250
Event Date 10/17/2010
Event Type  Malfunction   
Event Description
While performing an internal review of programming history it was noted that on (b)(6) 2010 the device was interrogated and programmed several times, a system diagnostic was performed and resulted in "fault", a final interrogation was performed and the settings were 1ma / 20 sf / 500 pw / 30 seconds on time / 60 minutes off time which are faulted diagnostic settings. Prior to the patient leaving the visit on (b)(6) 2010, the device was not programmed to intended settings. On (b)(6) 2010 the patient's settings were corrected to 1. 75m a, 20 sf, 250 pw, 30 seconds on time, 0. 8 minutes off time.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3070915
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« Reply #1333 on: April 16, 2018, 01:36:43 AM »

Model Number MODEL 250
Event Date 11/20/2006
Event Type  Malfunction   
Event Description
During review of programming history in the manufacturer programming history database it was noted on the date of implanted that there was an incomplete diagnostics that change the patient's settings. The change was noted by the physician but was only partially corrected. The output current was change back to 0 ma and but the magnet setting were left on. As this is a depression patient they typically do not have magnet stimulation enabled.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3079839
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« Reply #1334 on: April 16, 2018, 01:37:13 AM »

Model Number MODEL 250
Event Date 08/17/2011
Event Type  Malfunction   
Manufacturer Narrative
Review of programming history.
 
Event Description
During review of programming history, it was noted that a faulted system diagnostic test took place that altered device settings to unintended settings. No adverse events have been reported as a result of this.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075525
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« Reply #1335 on: April 16, 2018, 01:37:46 AM »

Model Number 250
Event Date 01/01/2010
Event Type  Malfunction   
Event Description
It was reported that the pt's generator had been set to settings indicative of an interrupted system diagnostic test at the time of device replacement surgery. It is unk if these settings were intended or not, but as they are not typical settings and are indicative of an interrupted system diagnostic test, a computer software error is suspected. The pt was set to these settings following surgery. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1880284
« Last Edit: July 24, 2018, 08:04:13 AM by dennis100 » Logged
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« Reply #1336 on: April 16, 2018, 01:45:15 AM »

Model Number 250
Event Date 07/16/2007
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of internal programming history, it was noted that a vns pt left their office at unintended therapy following an interrupted systems diagnostic test on (b)(6), 2007. The pt's settings were corrected at the next office visit on (b)(6), 2007. The site is aware how to avoid this event by interrogating before and after any testing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1961264
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« Reply #1337 on: April 16, 2018, 11:44:17 AM »

Model Number MODEL 250
Event Date 03/18/2013
Event Type  Malfunction   
Event Description
During review of programming history, it was noted that a faulted system diagnostic test likely changed device settings. While no final or subsequent interrogation is available, a normal mode diagnostic performed after multiple faulted system diagnostic tests show results typical for a device programed to a 0 ma output current; however, the device was not interrogated or programmed to a 0 ma output current prior to the normal mode diagnostic test. No adverse events have been reported as a result of this.
 
Manufacturer Narrative
Analysis of programming history.
 
Manufacturer Narrative
Previously submitted mdr inadvertently submitted the incorrect patient identifier. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3071628
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« Reply #1338 on: April 16, 2018, 11:44:46 AM »

Model Number MODEL 250
Event Date 04/03/2010
Event Type  Malfunction   
Event Description
During manufacturer review of a patient's vns programming history, it was identified that a faulted systems test occurred on (b)(6) 2010 at 09:28:45, the patient was then programmed to 2ma/30hz/500pulsewidth/30sec on/5min off at 09:27:43 and then another systems test followed at 09:30:41 which was successful, but no final interrogation was done to verify settings. At the next office visit on (b)(6) 2010, the initial interrogation at 11:33:41 has settings of 1ma/20hz/500pulsewidth/30sec on/60min off/1ma mag/500pulsewidth/30sec on, which is indicative of a faulted systems diagnostics test. The settings were all corrected on (b)(6) 2010.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3070735
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« Reply #1339 on: April 16, 2018, 11:45:15 AM »

Model Number MODEL 250
Event Date 05/10/2007
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) 2007 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2007. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2007. The device was not interrogated prior to the patient leaving the office on (b)(6) 2007 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) 2007. 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=3071574
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« Reply #1340 on: April 16, 2018, 11:45:45 AM »

Model Number MODEL 250
Event Date 06/08/2010
Event Type  Malfunction   
Event Description
During manufacturer review of a patient's vns programming history, it was noted a faulted systems diagnostics test occurred on (b)(6) 2010 which caused the settings to change. A final interrogation was not performed, and on (b)(6) 2010 the patient's device was interrogated and revealed the settings of 1ma/20hz/500pulsewidth/30sec on/60min off/1. 0ma mag/500pulsewidth/30sec on, which were not corrected at that time.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069291
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« Reply #1341 on: April 16, 2018, 11:46:12 AM »

Model Number MODEL 250
Event Date 09/25/2008
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During manufacturer review of a patient's vns programming history, it was noted that a systems diagnostics test faulted on (b)(6) 2008. The settings were corrected, but the off time remained at 60 minutes. It was not until (b)(6) 2010 that the off time was programmed to 5 minutes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069262

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« Reply #1342 on: April 16, 2018, 11:46:44 AM »

Model Number MODEL 250
Event Date 10/07/2009
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) 2009 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) 2009. The physician corrected the settings; however, the settings were not changed to the intended settings, but were changed to non-efficacious settings. The device was not interrogated prior to the patient leaving the office on (b)(6) 2009 as recommended by device manufacturer to ensure the device is at the correct settings; therefore, the patient left the office at non-efficacious settings. There was no programming history available that showed that the device has been reprogrammed to efficacious settings. 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=3071570
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« Reply #1343 on: April 16, 2018, 11:47:15 AM »

Model Number MODEL 250
Event Date 01/24/2007
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 at office visit on (b)(6) 2007 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2007. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2007. The device was not interrogated prior to the patient leaving the office on (b)(6) 2007 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) 2007. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3071539
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« Reply #1344 on: April 16, 2018, 11:47:46 AM »

Model Number MODEL 250
Event Date 02/21/2011
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2011 the patient's settings were different than what were programmed at the same office visit. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2011. The physician corrected the settings; however, the device off time and frequency were not corrected. The device was interrogated prior to the patient leaving the office on (b)(6) 2011 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the off time back to efficacious setting. The setting was corrected on (b)(6) 2012. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3071535
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« Reply #1345 on: April 16, 2018, 11:48:14 AM »

Model Number 250
Event Date 03/05/2009
Event Type  Malfunction   
Event Description
During review of the patient's programming history on (b)(6) 2013, it was observed that a faulted system diagnostics test occurred on (b)(6) 2009 that changed the patient's settings to faulted test settings. No final interrogation was performed and it was not until the patient's next visit on (b)(6) 2010 that these settings were observed and corrected. No patient adverse event was reported to have occurred due to this settings change.
 
Manufacturer Narrative
Analysis of programming history.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3071419
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« Reply #1346 on: April 16, 2018, 11:48:42 AM »

Model Number MODEL 250
Event Date 11/30/2005
Event Type  Malfunction   
Event Description
During review of programming history, it was noted that a faulted generator diagnostic test altered device settings. 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=3070801
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« Reply #1347 on: April 16, 2018, 11:49:09 AM »

Model Number MODEL 250
Event Date 06/13/2005
Event Type  Malfunction   
Event Description
During review of programming history it was observed that a incomplete systems diagnostics occurred that left the patient programming to unintentional settings. There was no final interrogation prior to the patient leaving the office and the setting changed was not noticed and only partially corrected at the next appointment. The off time was left a 60 minutes off and was not lowered until (b)(6) 2006.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3070284
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« Reply #1348 on: April 16, 2018, 11:49:44 AM »

Model Number MODEL 250
Event Date 09/13/2008
Event Type  Malfunction   
Event Description
During review of programming history it was observed that a incomplete systems diagnostics occurred that left the patient programming to unintentional settings. There was no final interrogation prior to the patient leaving the office and the setting changed was not noticed and corrected until the next appointment.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3070213
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dennis100
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« Reply #1349 on: April 16, 2018, 11:50:15 AM »

Model Number MODEL 250
Event Date 02/08/2010
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During manufacturer review of a patient's vns programming history, it was observed that diagnostic data does confirm that a systems diagnostics test was interrupted on (b)(4) 2010, which inadvertently changed the patient's settings to lead test parameters and no final interrogation to verify settings occurred. It was not until (b)(4) 2010, that the settings in question were found and corrected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069311
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