Pages: 1 ... 61 62 [63] 64   Go Down
Print
Author Topic: Unintentional Settings  (Read 195900 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1860 on: March 23, 2019, 01:24:01 AM »

Model Number MODEL 250
Device Problems Use of Incorrect Control Settings; Failure of Device to Self-Test
Event Date 04/15/2014
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) 2014 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2014. The settings found were indicative of a faulted diagnostic test; however, review of system diagnostic testing does not identify a faulted diagnostics that may have caused the change in settings. The settings were corrected on (b)(6) 2014. No patient adverse events were reported.
 
Event Description
It was reported that the patient was seen on (b)(6) 2014 and device settings upon interrogation were unchanged indicating that the fault did not occur until this visit. It was confirmed that this was the only visit prior to finding the change in settings which narrows the event down to this date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5294000
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1861 on: March 23, 2019, 01:24:43 AM »

Model Number MODEL 250
Event Date 09/21/2006
Event Type  Malfunction   
Event Description
Programming history was reviewed and it was found that a system diagnostic test occurred on (b)(6) 2006 which faulted settings to unintended settings. A final interrogation was not performed on (b)(6) 2006 and patient came back into the office on (b)(6) 2006 at the unintended settings. It is unknown if the patient was programmed back to intended settings since this is the last known programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5295578
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1862 on: March 24, 2019, 02:00:21 AM »

Model Number MODEL 250
Event Date 04/14/2015
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic history, it was observed that a programming anomaly occurred on a vns patient¿s device that caused an unintended change in device settings found in office visit on (b)(6) 2015. The normal mode and magnet mode were changed to 0 ma. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5260456
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1863 on: March 24, 2019, 02:01:10 AM »

Model Number MODEL 250
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a periodic review of the programming history database it was found what appears to be a faulted system diagnostics test that resulted in a change of settings. On (b)(6) 2007 the patient was at settings of output=1. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 75ma/magnet pulse width=250usec/magnet on time=30sec for the final interrogation. On (b)(6) 2008 the patient was found at settings of output=0ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60min/magnet output=0ma/magnet pulse width=250usec/magnet on time=30sec which appears to have been due to a faulted system diagnostics test. It is unknown when this occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5270420
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1864 on: March 24, 2019, 02:01:48 AM »

Model Number MODEL 250
Event Date 12/15/2009
Event Type  Malfunction   
Event Description
A programming history review was performed (b)(6) 2015 and it was found that on (b)(6) 2009 a faulted system diagnostics test changed the patient's settings and no final interrogation was performed. The settings change was not noticed until the next visit on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5274241
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1865 on: March 25, 2019, 02:15:47 AM »

Model Number MODEL 250
Event Date 03/10/2011
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that the vns patient's device was programmed to settings indicative of an interrupted system diagnostic test. The source of the interrupted system diagnostic is unknown. No patient adverse events were reported. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5375149
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1866 on: March 25, 2019, 02:16:22 AM »

Model Number MODEL 250
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic history, it was identified, during an office visit on (b)(6) 2014, that an interrupted system diagnostic test occurred that caused an unintended change in device settings. It's unknown when that change in device settings occurred. The settings were corrected on (b)(6) 2014 when the event was found. Diagnostics history was reviewed and no record was found of an interrupted system diagnostic test that might have caused the change in device settings. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5375832
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1867 on: March 26, 2019, 02:36:57 AM »

Model Number MODEL 250
Device Problems Use of Incorrect Control Settings; Failure of Device to Self-Test
Event Date 09/03/2015
Event Type  Malfunction   
Event Description
During review of the in-house programming history database, it is suspected that a faulted system diagnostic test occurred after (b)(6) 2015. On (b)(6) 2015 a system and normal mode diagnostics were performed. A final interrogation was performed confirming the correct settings. On the next recorded office visit, the settings were found to be at unintended parameters. The device was programmed to intended settings on (b)(6) 2014. No patient adverse events were reported.
 
Event Description
Additional information was received from the physician assistant that patient's change in settings due to computer software error occurred on (b)(6) 2015. The physician assistant mentioned that she had trouble interrogating the patient's device on (b)(6) 2015. She was able to interrogate the settings initially but was unable to program. She performed troubleshooting by replacing the cables, securing cable connections and replacing the tablet/handheld devices. She then identified the issue to be due to wand battery depletion by performing the battery test. When the 9v wand battery was changed, the patient's generator was able to be programmed. The change in the patient's device settings were corrected the same visit. Product information was requested but were not provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5355510
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1868 on: March 26, 2019, 02:37:50 AM »

Model Number MODEL 250
Event Date 05/15/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Review of the manufacturer's in-house programming history data observed an unintended change in settings. The data for the diagnostic that caused the unintended settings and the date that it occurred is not available in the in-house programming history database to-date. The settings were corrected on (b)(6) 2014. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5357984
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1869 on: March 26, 2019, 02:38:41 AM »

Model Number MODEL 250
Device Problem Device Operates Differently Than Expected
Event Date 12/29/2014
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) 2015. The settings were not corrected on the same date. No patient adverse events were reported.
 
Manufacturer Narrative
Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Description of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event description. Relevant tests/laboratory data, including dates; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Other, software version ; corrected data: the previously submitted mdr inadvertently provided an incorrect software version.
 
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 patient's programming settings were first corrected during the next clinic visit on (b)(6) 2015. No patient adverse events were reported.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong serial number and software number.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5366285
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1870 on: March 26, 2019, 02:39:37 AM »

Model Number MODEL 250
Event Date 10/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during an office visit on (b)(6) 2014. The physician corrected the settings; however, the output current off time was not corrected. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5366099
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1871 on: March 26, 2019, 02:40:25 AM »

Model Number MODEL 250
Event Date 01/11/2007
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during surgery on (b)(6) 2007. A finial interrogation was performed but the patient's device settings were not corrected during the procedure. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5366807
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1872 on: March 28, 2019, 07:10:16 AM »

Model Number MODEL 250
Event Type  Malfunction   
Event Description
It was reported that the patient's device settings were identified to be at settings indicative of a faulted diagnostic test. The physician identified the settings during the physician's first visit with the patient. The patient reported that her previous physician was retired and that the physician was unknown. The new physician reprogrammed the device settings and plans to see the patient in follow-up. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5452365
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1873 on: March 30, 2019, 01:32:58 AM »

Model Number MODEL 250
Event Date 06/26/2012
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. The settings found were indicative of a faulted diagnostic test; however, review of system diagnostic testing from office visit on (b)(6) 2012 was within normal limits. 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. The settings were corrected on (b)(6) 2012. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3410854
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1874 on: March 31, 2019, 06:52:23 AM »

Model Number MODEL 250
Event Date 07/15/2014
Event Type  Malfunction   
Event Description
It was observed during a review of the manufacturer's in house programming history data that the patient was inadvertently programmed to 60 minutes of off time resulting in a low therapy level. This was the result of a faulted systems diagnostics test on (b)(6) 2014 that reprogrammed the device. The settings were then re-programmed on (b)(6) 2014 to correct the faulted diagnostics test, however the off time of 60 minutes was not corrected. An increase in seizure activity below the pre-vns baseline was reported and it was attributed by the medical professional to be due to the unintentional sub-therapeutic levels due to the vns off time being too high. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5486316
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1875 on: April 05, 2019, 12:55:32 AM »

Model Number MODEL 250
Event Date 05/20/2010
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Settings on (b)(6) 2010 show the device programmed to intended settings. System diagnostics on (b)(6) 2010 after this programming event show faulted diagnostics. Settings from (b)(6) 2010 show interrogation with settings indicative of faulted diagnostics. The device was programmed on to intentional settings on (b)(6) 2010.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5710308
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1876 on: April 06, 2019, 12:12:47 AM »

Model Number 102
Device Problem Output Problem
Event Date 12/06/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's settings were inadvertently "zeroed out" at a patient's previous appointment in december. The session report at the patient's last appointment in july, everything was fine. Programming history was reviewed and it was confirmed that the patient's normal mode output current was 0 ma upon interrogation in december; however, data from the appointment at july was unavailable. It is known that because 102 generators temporarily changes the programmed settings to run system diagnostics test, interrupted diagnostics may lead to unintended settings changes. In labeling, it indicates that final interrogations should be performed at the end of every appointment to confirm correct settings. It is suspected that an interrupted test occurred at the previous appointment and the physician did not confirm the settings with a final interrogation, but this has not yet be confirmed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8445336
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1877 on: April 07, 2019, 01:40:34 AM »

Model Number 102
Device Problem Energy Output Problem
Event Date 02/14/2019
Event Type  Malfunction   
Event Description
It was reported that upon interrogation it was found that the patient's generator output current was programmed off. The patient was programmed back to intended settings by the company representative and it was reported that the device diagnostics were within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8408193
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1878 on: April 09, 2019, 12:12:56 AM »

Model Number MODEL 250
Event Date 05/09/2016
Event Type  Malfunction   
Event Description
It was reported that during an office visit on (b)(6) 2016 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2016. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2016. The device was not interrogated prior to the patient leaving the office on (b)(6) 2016 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. As a result of the changed setting the patient experienced painful stimulation. The settings were then adjusted on (b)(6) 2016. No additional relevant information has been received to date.
 
Event Description
An sd card containing a copy of the physician's tablet was received. The data was reviewed and confirmed that the output current was set to 0ma prior to a faulted diagnostic test with no final interrogation. The following day the generator was interrogated and output current was found to be set to 1ma. The data also confirmed that diagnostic results were within normal limits when the patient was experiencing the painful stimulation. Additionally, the data indicated that the patient was programmed off on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698270
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1879 on: April 10, 2019, 12:52:32 AM »

Model Number MODEL 250
Event Date 10/01/2014
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) 2014 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2014. The settings found were indicative of a faulted diagnostic test; however, review of system diagnostic testing from office visit on (b)(6) 2014 was within normal limits. The device was interrogated prior to the patient leaving the office on (b)(6) 2014 as recommended by device manufacturer to ensure the device is at the correct settings; therefore, the change in settings occurred after the (b)(6) 2014 visit. The physician indicated that the patient was not seen in between these two dates; however, it is unknown if the patient was seen by another physician during this time. No patient adverse events were reported. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5807233
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1880 on: April 10, 2019, 12:53:28 AM »

Model Number MODEL 250
Event Date 06/24/2015
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic history, it was identified that a device which was programmed on (b)(6) 2015 at 1. 75ma of output, were found at 0ma output on (b)(6) 2015. When this issue was found, it was corrected on the same date. No patient adverse events were reported. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. No further information was provided to date.
 
Event Description
Further information was received from the physician indicating that when the patient came to the clinic-visit on (b)(6) 2016 at 09. 55 am, the first interrogation revealed the same settings than the previous clinic visit. At 9. 59 am, an interrupted system diagnostic test occured, and this was then corrected at the same visit, back to the settings recorded at the first interrogation. Review of manufacturing records confirmed all tests passed for the concerned tablet prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5836189
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1881 on: April 11, 2019, 01:45:43 AM »

Model Number MODEL 250
Event Date 03/10/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was identified during the manufacturer's review of the in-house programming history that a programming anomaly occurred on (b)(6) 2015. The device was interrogated and system diagnostics were ran. The system diagnostics indicated there was faulted communication during the diagnostic test. The settings were found seven hours later at unintended parameters indicative of a faulted test. The settings were corrected at this visit on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5781844
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1882 on: April 12, 2019, 12:24:14 AM »

Model Number 250
Event Date 07/14/2016
Event Type  Malfunction   
Event Description
It was reported by the company representative that the patient had come in for a vns replacement surgery. Upon interrogation of the device, the settings were found to be indicative of a faulted diagnostic test. It was explained to the surgeon that the settings found during interrogation were indicative of a faulted diagnostic test. The neurologist's physician's assistant was notified and stated the last time the checked the device was (b)(6) 2016 and he was able to provide the intended settings. The physician's assistant noted that when performing diagnostics on that date, the patient had a weird tightening sensation in her chest, so the diagnostics were interrupted. Due to the patient's tightness, they were unable to perform a final interrogation to verify the settings. It was explained to the physicians at that time that the patient would have been programmed at the unintended settings since (b)(6) 2016 until the day of surgery (2 weeks). After the implant was complete, the surgeon decided to program the patient back to the intended settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5913259
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1883 on: April 13, 2019, 03:37:37 AM »

Model Number MODEL 250
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 05/18/2016
Event Type  Malfunction   
Event Description
On (b)(6) 2016 information was received regarding a patient with a m102 generator. Reportedly on the first interrogation during the patient's office visit the patient's generator was not programmed to the settings the physician set. It is currently unclear how the patient's settings were changed at this time. The parameters were reset and the patient was ok. No further addition information has been received to date.
 
Event Description
It was reported by the physician's nurse that he does have another programming system device that was used to interrogate this patient's generator. The nurse stated that the patient was only seen in (b)(6) , and not in (b)(6), so the data from may was the most recent, but another hand held was used and she believes that device may show that settings changed no additional relevant information has been received to date.
 
Event Description
Additional programming data was received which showed that a faulty diagnostic test was the cause of the change in settings. This change in settings was corrected by a different programming system during the same visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5912060
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1884 on: April 13, 2019, 03:38:08 AM »

Model Number MODEL 250
Event Date 10/22/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A review of the manufacturer's in-house programming data on 07/24/2016 indicated that on (b)(6) 2015, a system diagnostic was performed on a patient';s device and resulted in a "fault" in communication. On (b)(6) 2015 the device was interrogated and the settings had been changed to unintended parameters consistent with the faulted systems diagnostics. The device settings were then programmed back to intended parameters on (b)(6) 2016. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5897368
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1885 on: April 13, 2019, 03:38:40 AM »

Model Number MODEL 250
Event Date 01/01/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2016 a computer software event was identified from a review of the manufacturer's in-house programming history database. On (b)(6) 2011 the device was interrogated and system diagnostics were performed. One test resulted in a "fault," and the other was successful. The device was then programmed to intended settings in the same visit and there was no evidence that a software error occurred on this day. However, on the next recorded visit dated (b)(6) 2015 the device was interrogated and the settings were indicative of an interrupted diagnostic which had set the device to unintended settings. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5893452
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1886 on: April 13, 2019, 03:39:18 AM »

Model Number MODEL 250
Event Date 01/16/2015
Event Type  Malfunction   
Event Description
During review of the in-house programming history database, it was observed that a faulted system diagnostic test occurred on (b)(6) 2015. A final interrogation was not performed prior to the patient leaving the clinic. On the next recorded office visit, the settings were found to be at unintended parameters. These settings appear to be due to the faulted diagnostic tests on the previous visit. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5886307
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1887 on: April 15, 2019, 12:24:04 AM »

Model Number MODEL 250
Event Date 03/19/2013
Event Type  Malfunction   
Event Description
Review of the patient's in-house programming history identified a likely programming anomaly sometime between (b)(6) 2012 and (b)(6) 2013 that turned the off time from 5min to 60sec unintentionally. There were no noted diagnostic tests between those dates. A final interrogation was performed on (b)(6) 2012 which confirmed the intended settings. Upon initial interrogation on (b)(6) 2013, the off time was at 60min.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5867478
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1888 on: April 17, 2019, 06:38:45 AM »

Model Number MODEL 250
Event Date 03/31/2015
Event Type  Malfunction   
Event Description
A programming history review for the generator revealed a programming anomaly occurred on (b)(6) 2015 that changed device settings and therapy. On (b)(6) 2015 the device was interrogated and then programmed to the new and desired settings. The next interrogation the settings were changed to system diagnostic settings, which decreased the output current and therapy being given by the device. The device was programmed again on the same day, but the only parameter changed was the frequency from 20hz to 30hz, therefore the patient was receiving less therapy than intended. The settings were not changed again until a later visit on (b)(6) 2015, but were still set lower than the original settings on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5955851
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1889 on: April 21, 2019, 03:13:06 AM »

Model Number MODEL 250
Event Date 07/24/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a programming history review of the patient's generator on 8/8/2016, it was discovered that the device had a change of settings between visits as well as a change in the programmed implant date and initials. A cross-programming event between the two generators is suspected to have occurred on (b)(6) 2014. The patient's settings were adjusted by the neurologist on (b)(6) 2014. Due to the susceptibility of model 100, 101, and 102 pulse generators to cross-programming, labeling recommends that an initial and a final interrogation be performed at each office visit for all vns patients in order to verify parameter settings. Patients with initials (b)(6) were not seen by the neurologist on the same day. In the year 2014, patient (b)(6) was seen on (b)(6) 2014. Patient (b)(6) was seen on (b)(6) 2014. No additional relevant information was reported to have occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5926684
Logged
Pages: 1 ... 61 62 [63] 64   Go Up
Print
Jump to: