Pages: 1 ... 17 18 [19] 20   Go Down
Print
Author Topic: Unintentional Settings  (Read 5617 times)
0 Members and 4 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #540 on: August 31, 2017, 02:36:29 AM »

Model Number 258
Event Date 03/26/2009
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During a review the pt's programming history, it was noticed that a partial programming event occurred on (b)(6) 2009 following interrogation which resulted in the pt's device being reprogrammed to 0ma. The settings were not reprogrammed prior to the pt leaving the clinic. The settings were reprogrammed on the follow up visit on (b)(6) 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2443751
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #541 on: September 01, 2017, 01:50:27 AM »

Model Number MODEL 250
Event Date 03/04/2009
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During a review of programming history, a programming anomaly was observed. On (b)(6) 2009, the patient was interrogated and a generator diagnostic was performed. The patient was not re-interrogated and left the appointment at un-intended settings. At the patient's next appointment on (b)(6) 2009, the patient was interrogated and found to be programmed off. The patient's settings were then corrected at that visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2418530
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #542 on: September 03, 2017, 01:23:25 AM »

Model Number 250
Event Date 07/29/2010
Event Type  Malfunction   
Event Description
During a review of the patient¿s programming history, it was found that on (b)(6) 2010, the patient¿s device was interrogated and found to be programmed to settings indicative of a faulted systems diagnostic test. The last systems diagnostic test was performed on (b)(6) 2010 and did not appear to have faulted, however, the device was not interrogated on (b)(6) 2010, to ensure the settings were not affected. On (b)(6) 2010, the patient¿s device was interrogated and found to be programmed off. The settings were corrected on (b)(6) 2010 and there were no reports of any patient adverse events as a result.
 
Manufacturer Narrative
Analysis of programming and device diagnostic history performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2478503
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #543 on: September 03, 2017, 01:24:06 AM »

Model Number MODEL 250
Event Date 03/02/2011
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional programming history was received on (b)(4) 2012. From the programming history, it does appear that the patient was at faulted settings from the date of the faulted system diagnostic test on (b)(6) 2011, until the patient was interrogated on (b)(6) 2012. On (b)(6) 2012, the patient's off time was left at 60 minutes. During a generator replacement in march, the newly implanted generator was also programmed to 60min off, which was previously reported in medwatch # 1644487-2012-01557. The patient has since been programmed back to efficacious settings.
 
Event Description
It was reported by the site that the patient was experiencing an increase in seizures. Additional information was obtained indicating that the patient started experiencing an increase in (b)(6) 2011. The patient was started on a new medication for the increase in (b)(6) and the medication was then increased in december. It was noted that the patient had experienced 3-4 seizures which was said to be above his baseline; however they did not know the reason for the increase. It was also reported that from (b)(6) 2011 until (b)(6) 2012, the patient had not had any seizures. The patient's settings were provided by the site, and an anomaly was identified. When the patient was recently interrogated on (b)(6) 2012, the patient was at settings indicative of a faulted diagnostic test. At that appointment, the patient's settings were changed, however it is unclear at this time if the off time was corrected from 60 minutes. The site also provided the patient's settings in (b)(6) 2011; however they were unable to provide any information on diagnostics which may have been performed. A review of programming history, available in house, revealed that a faulted system diagnostic test occurred on (b)(6) 2011 and a final interrogation was not performed at that time. It is likely that the patient has been programmed to unintended settings since the time of the faulted diagnostic test. The cause of the increase in seizures therefore may be related to the decrease in therapy that the patient was receiving due to the reduction in settings.
 
Event Description
Additional information was received on (b)(4) 2012, from a manufacturer's representative indicating that the patient may have still be at 60 minutes off time at an interrogation performed in (b)(6). Attempts for additional programming history to confirm the event have been unsuccessful to date.
 
Manufacturer Narrative
Age at time of event- corrected data: the patient's age at the time of the event was incorrectly reported on the initial manufacturer's report. The patient was (b)(6) when the event occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2464281
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #544 on: September 03, 2017, 01:24:39 AM »

Model Number 250
Event Date 01/31/2012
Event Type  Malfunction   
Event Description
Product analysis for the generator was completed and approved on (b)(6) 2012. There were no performance or any other type of adverse conditions found with the pulse generator. However, it was noted that the as-received settings of 1. 0ma/ 20hz/ 500usec/ 30sec/ 60min, which indicated a faulted systems diagnostics test likely resulted in the unintended settings. There is not enough information available at this time to know if this event is related to the explant procedure and testing or if the device was at unintended settings for some time. The pt's last known settings in the programming history available from the product analysis is on (b)(6) 2010 in which the settings were 1. 25ma/ 30hz/ 130usec/ 30sec/ 0. 5min. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2481243
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #545 on: September 03, 2017, 01:25:23 AM »

Model Number MODEL 250
Event Date 02/26/2007
Event Type  Malfunction   
Event Description
It was noted upon review of a patient's programming history that a partial programming event occurred at a follow-up appointment and was not corrected prior the patient leaving the physician's office. The patient was seen at a later date and the settings were corrected.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2469831
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #546 on: September 03, 2017, 01:26:13 AM »

Model Number 250
Event Date 02/20/2009
Event Type  Malfunction   
Event Description
A faulted systems diagnostic test occurred on (b)(6) 2009 which resulted in the pt's settings changing to untended parameters. The settings were not corrected until the subsequent visit on (b)(6) 2010.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2481221
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #547 on: September 04, 2017, 02:11:21 AM »

Model Number 250
Event Date 01/16/2009
Event Type  Malfunction   
Event Description
It was initially reported that the physician noticed that the patient was not at the settings that were recorded in the patient's chart. The settings were noticed and correct at the (b)(6) 2012 appointment. The review of the physician's handheld history showed that the patient had an appointment in (b)(6) 2011 and (b)(6) 2011 and the patient was not at the intended setting at either appointment. Review of the patient's programming history in the manufacturer programming history database showed that there was a faulted diagnostics on (b)(6) 2009 and the patients settings were not fully corrected by the last date in the programming history at this time of (b)(6) 2011. It appears that the patient may not have had their settings fully corrected since the faulted test on (b)(6) 2009. (b)(4) attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2488760
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #548 on: September 04, 2017, 06:59:04 AM »

Model Number MODEL 250
Event Date 07/27/2007
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the pt's programming history for file (b)(4) it was discovered that on (b)(6) 2007 a system diagnostics test occurred that changed the pt to 1/20/500/30/60, although a final interrogation was performed, the settings were not changed until the patient's next visit on (b)(6) 2007. This file was created to house the programming anomaly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2457048
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #549 on: September 04, 2017, 06:59:45 AM »

Model Number 250
Event Date 07/17/2008
Event Type  Malfunction   
Event Description
During a review of the programming history available to the mfr, it was observed that a partial programming event occurred on (b)(6) 2008, which changed the pt¿s settings to 0 ma. A final interrogation was performed as recommended in mfr labeling, however the unintended settings were not corrected prior to the pt leaving the office. It wasn¿t until (b)(6) 2008 that the pt¿s settings were corrected.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2472967
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #550 on: September 06, 2017, 01:46:55 AM »

Model Number 250
Event Date 07/25/2006
Event Type  Malfunction   
Event Description
During a review of the pt's programming history available in the in-house database, it was observed that a faulted systems diagnostic test occurred on (b)(6) 2006. Upon initial interrogation on the subsequent clinic visit on (b)(6) 2006, the settings were at unintended settings. The output current was reprogrammed to 1. 25ma on (b)(6) 2006, but the rest of the settings remained the same. The off time was not corrected to 3 min until (b)(6) 2006.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2452092
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #551 on: September 06, 2017, 08:57:42 AM »

Model Number 250
Event Date 04/19/2009
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Review of internal programming history identified that a computer software error occurred. On (b)(6) 2009, a computer software error occurred, but it was corrected before the patient left the office. There was a programming and an interrogation on (b)(6) 2009, before the patient left the office and everything appeared to be fine, but on (b)(6) 2009 (the next visit), upon interrogation the patient was a faulted settings. The settings were corrected on (b)(6) 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434153
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #552 on: September 10, 2017, 01:18:25 AM »

Model Number 250
Event Date 01/01/2008
Event Type  Malfunction   
Event Description
It was reported that a pt was programmed at different settings than what was intended. The physician stated that the pt was previously set at 0. 75 ma output current; however, when he showed up for his appt, his generator was set at 0 ma. The physician recalls performing device diagnostics, however, he could not recall whether or not he interrogated the pt's device after performing diagnostics to ensure that the pt's settings were correct. Additional information received from the physician revealed that he has seen the pt again and everything was okay. He has not had any additional problems and will not be returning his handheld or a copy of his flashcard for analysis. He does not suspect any device malfunction.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1297971
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #553 on: September 10, 2017, 10:13:52 AM »

Model Number MODEL 250
Event Date 04/10/2008
Event Type  Malfunction   
Event Description
During review of the patient's programming history on (b)(6) 2012 it was discovered that a faulted system diagnostics test occurred on (b)(6) 2008 which changed the patient's settings from output=2ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 8min/magnet on time=2. 25ma/magnet pulse width=500usec/magnet on time=30sec to settings of output=0ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 8min/magnet on time=0ma/magnet pulse width=500usec/magnet on time=30sec. Although a final interrogation was performed, the settings were not corrected until the patient's visit on (b)(6), 2009.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2475487
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #554 on: September 10, 2017, 10:14:28 AM »

Model Number MODEL 250
Event Date 01/01/2009
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Reporter indicated that they interrogated the pt's device and it appeared the device settings had been errantly changed. Programming history was downloaded from the handheld computer for review, which revealed there was an interrupted systems diagnostics test. Interruption of a systems diagnostics test can cause the generator's settings to be inadvertently set to the parameters that the diagnostics test is carried out at. The pt left the physician's office with the incorrect settings, and had the settings changed by the physician at the next office visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1375770
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #555 on: September 11, 2017, 04:00:28 AM »

Model Number MODEL 250
Event Date 09/23/2010
Event Type  Malfunction   
Event Description
During review of programming history, it was noted that an interrupted diagnostic test occurred on (b)(6) 2011 that altered device settings. The settings were not corrected prior to the patient leaving the office visit. No adverse events have been reported as a result of this event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3239057
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #556 on: September 12, 2017, 12:42:51 AM »

Model Number MODEL 250
Event Date 11/29/2007
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of the programing history it was noted that on the date of implant that there was an incomplete diagnostics that resulted in a setting change. There was no finial interrogation and the patient left at unintentional settings. The setting changed was noted at a later appointment and corrected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3256458

Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #557 on: September 13, 2017, 02:12:07 AM »

Model Number MODEL 250
Event Date 04/01/2010
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During review of the in-house programming/diagnostic history database, it was observed that on office visit on (b)(6) 2010, the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2010. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2010. The device was not interrogated prior to the patient leaving the office on (b)(6) 2010 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) 2010; however, the magnet was left on. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3352466
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #558 on: September 14, 2017, 12:43:57 AM »

Model Number MODEL 250
Event Date 03/07/2011
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming and device diagnostic history performed.
 
Event Description
During a review of the patient's programming history performed on (b)(6) 2012 it was observed that on (b)(6) 2011, the patient's settings changed due to a systems diagnostic test that did not complete successfully. While the test did not state "fault", the test did not complete as noted by the settings upon interrogation after the test was performed. While the physician made adjustments to the settings, the off time was significantly higher than what it was when the patient first came into the office on (b)(6) 2011. There were no reports of any adverse events as a result of the setting change.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2592591
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #559 on: September 14, 2017, 12:44:52 AM »

Model Number 302-30
Event Date 07/01/2011
Event Type  Malfunction   
Event Description
A vns consultant was at a physicians office and reported that she noted when she was looking at programming history on his handheld computer that their was a patient with a dcdc 0 on a system diagnostic test. The patient's records were reviewed and noted that the patient had been having some increase in seizures since their office visit in (b)(6) 2011. She reported that the diagnostic results she noted were low impedance with dcdc 0 on a system test. The patient's current settings are 2/20/250/30/1. 8. Clinic notes were received for review and noted the patient having increased seizures not above baseline, stimulation not perceived and they were having more choking episodes, since being implanted with their vns the patient does not have anymore grand mal seizures. Surgery is going to be planned sometime this summer but no date set at this time. (b)(4) attempts have been made and no further information has been attained.
 
Event Description
A vns consultant was at a physician's office and reported that she noted when she was looking at programming history on his handheld computer that there was a patient with a dcdc 0 on a system diagnostic test. The patient's records were reviewed and noted that the patient had been having some increase in seizures since their office visit in (b)(6) 2011. She reported that the diagnostic results she noted were low impedance with dcdc 0 on a system test. The patient's current settings are 2/20/250/30/1. 8. Notes were received documenting several events of increased seizures. Some seizures not above baseline and some were above baseline and a change in frequency and possibly type. The patient does not feel their vns stimulation and they were having more choking episodes since their last programming change. Since being implanted with their vns the patient does not have any more grand mal seizures. Additionally noted (b)(4) 2012, that the patient had had several seizures after his last visit. He missed his next visit because of a hospitalization. His seizure control is better now. He has never had much benefit from activating the vns. He never has felt it go off. His seizures are less severe now. Reported (b)(6) 2011 clinic visit. His wife reports that since his last visit he has continued to have increase numbers of seizure averaging about 8 to 13 seizures per month. His wife also says that he used to just tighten up with his seizures and now he is starting to have more rhythmic movement, and she is worried that they are increasing in severity along with frequency. She says that over the years his best seizure control has been about 2 to 3 per month, and he has had a vns for years. She worries his vns is less effective. His vns was interrogated to make sure the generator and battery were working well. There is no evidence that his vns is failing at this time. However, given that he is 4 years out i his doctor recommended more frequent interrogation, and they plan on rechecking that in 3 months. For further treatment of his seizures as he has not tolerated higher settings on his vns they will be adding vimpat. The patient does have a history of falls. Their surgery will be planned for some time this summer no date set at this time.
 
Manufacturer Narrative
Adverse event corrected data: omitted clinic information on initial mdr.
 
Event Description
The patient had their vns generator replaced. The explanted generator is in product analysis pending completion. The patient did not have their lead replaced.
 
Manufacturer Narrative

Manufacturer Narrative
Operator of device; corrected data: updated to patient. Type of event: corrected data omitted 30 day report on initial mdr.
 
Event Description
The pulse generator was returned due to prophylactic replacement. Although the reported allegations of "increased seizures", "dysphagia", "stimulation not perceived", "lack of efficacy", "change in seizure pattern", and "increased seizure intensity", cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
A vns consultant went to a clinic visit and it was noted after review of programming history in the site's handheld that there had been a generator diagnostic test performed on (b)(6) 2012. This test is addressed in medwatch report number: 1644487-2012-01176. The patient's generator had been reset to 0. 00ma. The patient's settings were not reviewed with a final interrogation prior to the patient leaving the office and was subsequently programmed to unintended settings from the test. The patient would not have been receiving therapy. The patient returned to the office on (b)(6) 2012 and the settings were corrected at that time. The site is now aware how to prevent this from happening. The patient is scheduled to have their generator replaced on (b)(6) 2012. Loss of therapy likely attributed to the patient's seizure events since (b)(6) 2012. It is not suspected that the patient has a lead issue at this time. Likely a normal mode diagnostic test was performed when the device was programmed off. No further information has been received about the patient's reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2512499
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #560 on: September 16, 2017, 01:00:21 AM »

Model Number 250
Event Date 01/11/2011
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description
Information was received that while a vns consultant was at a clinic it was noted that a patient had a faulted system diagnostic test in their programming history. The patient's programming history was reviewed, which revealed an interrupted system diagnostic test on (b)(6) 2011. The patient's settings were 1. 25/25/500/60/1. 1 prior to the programming anomaly and was programmed to 1. 25/20/500/30/60 prior to leaving the office. The patient's off time was corrected from 60 minutes to 5. 0mins at their office visit on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2554451
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #561 on: September 16, 2017, 01:01:01 AM »

Model Number MODEL 250
Event Date 12/18/2007
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
During review of programming history, it was noted that an interrupted system diagnostic and generator diagnostic occurred on (b)(6) 2007 that altered patient settings. The settings were not corrected prior to the patient leaving the office. No adverse events have been reported as a result of this.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3235416
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #562 on: September 17, 2017, 02:28:18 AM »

Model Number MODEL 250
Event Date 06/22/2010
Event Type  Malfunction   
Event Description
During review of the patient¿s programming history it was observed that a faulted diagnostics test occurred on (b)(6) 2010 that changed the patient's programmed settings. The settings were not changed back until the next visit on (b)(6) 2010, during which the patient was interrogated at output=0ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60min/magnet output=0ma/magnet pulse width=250usec/magnet on time=30sec, and settings were programmed back to output=0. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 75ma/magnet pulse width=250usec/magnet on time=30sec.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3483993
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #563 on: September 18, 2017, 12:37:07 AM »

Model Number MODEL 250
Event Date 10/30/2011
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) 2012 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 corrected on (b)(6) 2012. 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=3821498
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #564 on: September 19, 2017, 03:08:00 AM »

Model Number MODEL 250
Event Date 12/29/2008
Event Type  Malfunction   
Event Description
During review of programming history, it was noted that an interrupted system diagnostic test occurred that altered generator settings. The settings were not corrected prior to the patient leaving the office. No adverse events have been reported as a result of this.
 
Manufacturer Narrative
Review of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3039726
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #565 on: September 20, 2017, 01:45:52 AM »

Model Number MODEL 350
Event Date 03/12/2004
Event Type  Malfunction   
Event Description
During the periodic programming history review, it was found that an interrupted system diagnostic test or partial programming event occurred which caused an unintended change in the patient¿s vns settings. The settings were not corrected at the time of the event. No adverse events have been reported as a result of this occurrence.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3354789
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #566 on: September 21, 2017, 12:56:31 AM »

Model Number MODEL 250
Event Date 07/26/2006
Event Type  Malfunction   
Event Description
In reviewing programming history for a vns pt, it was noted that the pt's device settings were re-programmed due to an interrupted system diagnostics test. A final interrogation was performed. But no changes were made to the device settings. The pt left the office visit with the non desired device settings. The device settings were reprogramed at a later date. No serious injury was reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=887967
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #567 on: September 22, 2017, 01:15:02 AM »

Model Number 250
Event Date 04/27/2006
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Review of programming history indicates that the patient's vns generator was inadvertently set to deliver stimulation. The settings were likely caused by an interrupted system diagnostic test during device implantation. No final interrogation was performed during surgery. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861303

Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #568 on: September 23, 2017, 03:47:43 AM »

Model Number MODEL 250
Event Date 12/06/2010
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) 2010. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2010. The device was not interrogated prior to the patient leaving the office on (b)(6) 2010 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) 2011. 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=3081001
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 44426


« Reply #569 on: September 24, 2017, 02:08:43 AM »

Model Number MODEL 250
Event Date 07/06/2010
Event Type  Malfunction   
Event Description
During review of the patient's programming history, it was observed that a faulted system diagnostic test occurred on (b)(6) 2010 which changed the settings to unintended parameters. The settings were not corrected until (b)(6) 2010. A final interrogation was performed on (b)(6) 2010 but the settings were not corrected prior to the patient leaving the clinic. No adverse events were reported as a result.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3004989
Logged
Pages: 1 ... 17 18 [19] 20   Go Up
Print
Jump to: