Pages: 1 [2] 3 4 ... 9   Go Down
Print
Author Topic: Short Circuit  (Read 77932 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #30 on: March 23, 2012, 08:48:24 AM »

Model Number 302-20
Event Date 08/22/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt did not experience any efficacy with vns therapy. Diagnostics performed on the device revealed proper device function. Review of programming history and confirmation with the physician revealed that multiple settings have been attempted to achieve greater efficacy. No interventions were taken for this event. If present, an intermittent short-circuit could have potentially contributed to the pt's lack of efficacy event.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476478
« Last Edit: November 23, 2015, 03:06:44 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #31 on: March 23, 2012, 08:48:49 AM »

Model Number 302-20
Event Date 08/22/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. The pt's physician reported that the pt experienced an increase in seizures below pre-vns baseline due to possible battery depletion. Diagnostics performed on the device revealed proper device function. The pt's generator was replaced prophylactically and returned to the mfr for product analysis. Product analysis did not reveal any anomalies that may have contributed to the reported event. The end of service allegation was not duplicated in the product analysis laboratory. If present, an intermittent short-circuit could have potentially contributed to the pt's increased seizure activity, though this activity was still below pre-vns levels.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476480
« Last Edit: November 23, 2015, 03:07:08 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #32 on: March 23, 2012, 08:49:14 AM »

Model Number 300-20
Event Date 07/26/2006
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a pt could no longer feel vns stimulation and was also having increased seizures. All attempts for further info from the reporter were unsuccessful. The pt later underwent vns generator replacement and was still unable to feel vns stimulation. The explanted generator was returned for analysis. No anomalies were noted and the generator performed per specifications. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device. This file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476488
« Last Edit: November 23, 2015, 03:07:30 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #33 on: March 23, 2012, 08:49:36 AM »

Model Number 302-20
Event Date 07/04/2006
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mr, no gross lead discontinuities visualized. Conclusion code: device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns pt experienced painful stimulation at the generator site along with muscle spasms in the left arm. X-rays were reviewed which did not identify any obvious lead discontinuities, but a sharp angle was noted in the lead near the lead/pin generator header interface. The pt underwent vns generator replacement surgery and the symptoms resolved. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device. This file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476490
« Last Edit: November 23, 2015, 03:07:51 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #34 on: March 23, 2012, 08:50:02 AM »

Model Number 302-30
Event Date 06/02/2006
Event Type Malfunction
Event Description
Reporter indicated: a pt had pain with vns stimulation at the generator site. Attempts to the reporter for further info were unsuccessful as the pt did not follow up with the reporter. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476491
« Last Edit: November 23, 2015, 03:08:16 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #35 on: March 23, 2012, 08:50:25 AM »

Model Number 300-20
Event Date 11/15/2005
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Rptr indicated that a vns pt underwent vns lead and generator replacement surgery due to facial pain. The face pain reportedly resolved following replacement surgery. The explanted lead and generator were returned for analysis. Analysis of the generator did not reveal any anomalies and the generator performed per specifications. No anomalies were identified with the returned portions of the vns lead and therefore no findings that could have contributed to the facial pain complaint. Note that since part of the lead assembly (approx 50%) was not returned for analysis an eval and resulting commentary cannot be made on the portion of the lead. Other than typical wear and explanted related observations, there were no findings or anomalies noted on the returned portion of the lead. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly to a related a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476493
« Last Edit: November 23, 2015, 03:08:40 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #36 on: March 23, 2012, 08:50:57 AM »

Model Number 300-20
Device Problem No Information
Event Date 05/14/2009
Event Type Malfunction
Event Description
As a part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. The reporter indicated that a vns patient had requested that his vns device be explanted as he felt that he had not received efficacy from therapy and added that his device had been programmed off for quite some time. A review of the patent's programming history revealed that the patient's generator was near end of service prior to device disablement. Good faith attempts to the patient's treating vns therapy physician assessment of the patient's lack of efficacy have been unsuccessful to date. Follow up with the patient's surgical facility revealed that the explanted device had been disposed of following surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476496
« Last Edit: November 23, 2015, 03:09:00 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #37 on: March 23, 2012, 08:51:20 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 03/13/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short circuit condition. It was reported that a vns patient had experienced an increase in seizures, below pre-vns baseline levels, just prior to generator revision surgery. The patient's seizure activity reportedly began to decrease two days after revision surgery. Follow up with the patient's treating vns therapy physician revealed that she did not believe the patient's seizures were due to vns and added that the patient's generator had been replaced prophylactically. If present, an intermittent short-circuit could have potentially contributed to the patient's increased seizure activity, though this activity was still below pre-vns levels.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476497
« Last Edit: November 23, 2015, 03:09:23 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #38 on: March 23, 2012, 08:51:45 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 06/07/2006
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt was experiencing an increase in seizures, below pre-vns baseline levels. The pt's treating vns therapy physician indicated that the pt's device had been programmed to a 1% duty cycle (30 seconds of stimulation /60 minutes of no stimulation). The physician adjusted the pt therapy settings in an effort to improve the pt's efficacy with therapy. Later, pt clinic notes were received indicating that the pt had fallen after having a seizure which resulted in a cut to his forehead and necessitated stitches. The clinic notes state that the pt's mother had mentioned that the pt had changed medications prior to this event. Device diagnostics performed two months after the pt's fall resulted in a dcdc code of 0.

Manufacturer Narrative
Device failure is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476498
« Last Edit: November 23, 2015, 03:09:48 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #39 on: March 23, 2012, 08:52:06 AM »

Model Number 300-20
Device Problem Low impedance
Event Date 01/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was not found to be possibly related to a short-circuit condition. Patient has a history of seizure flurries and it is not uncommon for the patient to have a flurry of seizures. The normal mode diagnostics indicate that the device is able to deliver it's programmed settings and was not at eos. Unknown cause from the site for the patient's seizure flurry, but is part of the patient's seizure history.

Manufacturer Narrative
Device malfunction is suspected, but did not contribute to a death or serious injury

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476499
« Last Edit: November 23, 2015, 03:10:11 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #40 on: March 23, 2012, 08:52:34 AM »

Model Number 300-20
Device Problem Electrical shorting
Event Date 01/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was initially reported that the pt began to "have a few breakthrough seizures which until now have been relatively well controlled for several years. " in addition, there was a concern of "early battery failure. " diagnostic testing found all systems intact and functioning normally with dcdc: 0 and eri = no. The pt's output current was increased to 2. 75ma which resulted in "an uncomfortable coughing and choking sensation in her ear and throat. " follow-up with the physician indicated that the pt's seizures were still below pre-vns levels which may have been related to the pt "getting sick due to infection. " the infection was not related to the vns but rather poor hygiene. The physician further explained that the pt's choking and coughing was related to intolerable settings as decreasing the pt's settings resolved the events. It was also noted that the pt was experiencing some weight loss. It was later reported on a follow-up that the pt is "continuing to tolerate the stimulator system well with no remarkable subjective complaints. There have been no changes in her general health status. " there is no allegation that the pt's weight loss is causing harm to the pt.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476500
« Last Edit: November 23, 2015, 03:10:37 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #41 on: March 23, 2012, 08:52:58 AM »

Model Number 300-20
Event Date 04/29/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the pt was experiencing an increase in seizures (below pre-vns-baseline). Per the physician, the believed cause of the increase is few missed doses of epilepsy medication. Device diagnostics were within normal limits with dc/dc code = 0. No further info is available at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476024
« Last Edit: November 23, 2015, 03:11:01 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #42 on: March 23, 2012, 08:53:25 AM »

Model Number 302-20
Event Date 05/23/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the pt was experiencing an increase in seizures (below pre-vns baseline) and had her generator prophylactically replaced. No further info is available to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476027
« Last Edit: November 23, 2015, 03:11:22 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #43 on: March 23, 2012, 08:53:54 AM »

Model Number 302-20
Event Date 11/01/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possible related to a short-circuit condition. It was reported that the pt was coughing when the device stimulated. The physician turned the output current down which alleviated the coughing for a few months, but then it started again. The physician did not know why the pt could not tolerate the stimulation. The device was turned off for a few weeks, and then turned back on to 0. 5 ma. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476029
« Last Edit: November 23, 2015, 03:11:45 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #44 on: March 23, 2012, 08:54:21 AM »

Model Number 302-20
Event Date 09/12/2005
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. Reporter indicated a vns pt was unable to feel regular or magnet mode vns stimulation

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476030
« Last Edit: November 23, 2015, 03:12:07 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #45 on: March 23, 2012, 08:54:46 AM »

Model Number 302-20
Event Date 07/21/2005
Event Type Malfunction
Manufacturer Narrative
Conclusions - device failure is suspected, but did not cause or contributed to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation a low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. Reporter indicated a vns pt could no longer feel vns stimulation

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476032
« Last Edit: November 23, 2015, 03:12:29 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #46 on: March 23, 2012, 08:55:41 AM »

Model Number 300-UNK
Event Date 10/09/2004
Event Type Malfunction
Manufacturer Narrative
Device failure suspected.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported in medwatch 1644487-2007-01852 that the vns pt had not had good seizure control over the last three years.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476034
« Last Edit: November 23, 2015, 03:12:54 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #47 on: March 23, 2012, 08:56:10 AM »

Model Number 300-20
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient showed increase in seizures but not above pre-vns baseline. The site thought that the battery was nearing end-of-service, however, battery life calculation showed approximately 2. 53 years before eri=yes. Site mentioned about dcdc code equal to zero and they thought there might have been some lead issue. Good faith attempts to obtain additional information was unsuccessful. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478393
« Last Edit: November 23, 2015, 03:13:23 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #48 on: March 23, 2012, 08:56:39 AM »

Model Number 302-20
Event Date 01/01/2005
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient had increase in cough. Patient had (b) (6), but vns system normally elicits the cough. Cough is worsened at night. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478394
« Last Edit: November 23, 2015, 03:13:49 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #49 on: March 23, 2012, 08:57:08 AM »

Model Number 302-20
Event Date 05/01/2005
Event Type Malfunction
Event Description
Please refer to report # 1644487-2005-00365. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478396
« Last Edit: November 23, 2015, 03:14:12 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #50 on: March 23, 2012, 08:57:39 AM »

Model Number 302-20
Event Date 01/01/2005
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported that the patient had an increase in seizures and patient's mom believe that the battery was dead or not working properly. No additional information was received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478398
« Last Edit: November 23, 2015, 03:14:55 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #51 on: March 23, 2012, 08:58:13 AM »

Model Number 302-20
Event Date 03/01/2009
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported that the patient is having pain in her neck, ear, throat, and mouth with stimulation. No trauma or manipulation was reported. Patient's device was turned off and then turned back on once pain disappeared. Patient was set to low output current and is doing great now.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478400
« Last Edit: November 23, 2015, 03:15:25 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #52 on: March 23, 2012, 08:58:46 AM »

Model Number 300-20
Event Date 10/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported in medwatch 1644487-2007-01890 that the patient was experiencing an increase in seizures, which was later found to be less than her baseline level of seizures, and was believed to be due to the generator nearing eos.

Manufacturer Narrative
Device failure suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478410
« Last Edit: November 23, 2015, 03:15:53 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #53 on: March 23, 2012, 08:59:25 AM »

Model Number 300-20
Event Date 09/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. Reporter indicated that the patient was experiencing an increase in seizure activity, however, it was not worse than before starting vns therapy, and the physician felt the event may be due to stressors in the patient's life, and not vns therapy.

Manufacturer Narrative
Device failure suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478411
« Last Edit: November 23, 2015, 03:16:24 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #54 on: March 23, 2012, 08:59:59 AM »

Model Number 300-20
Event Date 09/04/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. Reporter indicated that the patient was experiencing pain and muscle spasms in his neck during stimulation, that were more tolerable at lower output current settings.

Manufacturer Narrative
Device failure suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478412
« Last Edit: November 23, 2015, 03:16:55 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #55 on: March 23, 2012, 09:00:36 AM »

Model Number 302-20
Event Date 12/14/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported that the patient was experiencing an increase in seizures back to pre-vns baseline. The physician did not believe the increase was related to vns therapy and prior to the onset, that patient had changed her depakote dosing. The physician increased the patient's medication to address the event. No further information is available.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478413
« Last Edit: November 23, 2015, 03:17:25 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #56 on: March 23, 2012, 09:01:12 AM »

Model Number 302-30
Event Date 03/01/2007
Event Type Malfunction
Event Description
Initial reporter indicated that their patient was having an increase in seizures. In the last 2. 5 months he has been having a lot of seizures. Not over his pre vns baseline and the doctor is attributing them to the patient's stress that he is having at the moment. As part of a retrospective complaint review associated with an investigation of how impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly replated to a short-circuit condition.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478431
« Last Edit: November 23, 2015, 03:18:03 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #57 on: March 23, 2012, 09:01:49 AM »

Model Number 300-20
Event Date 03/15/2007
Event Type Malfunction
Event Description
It was reported that a vns patient experienced cough and subsequent muscle spasms in the neck with vns stimulation. X-rays were taken and reviewed at manufacturer no anomalies were observed. The patient's treating physician did witness the muscle spasms and correlated it with stimulation cycles. The patient's device was disabled and both cough and muscle spasms resolved. There are no plans to turn on the device. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

Manufacturer Narrative
Manufacturer review of x-rays. Results - x-rays reviewed by manufacturer, no gross lead discontinuities visualized. Conclusions - device malfunction suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478433
« Last Edit: November 23, 2015, 03:18:41 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #58 on: March 23, 2012, 09:02:22 AM »

Model Number 302-20
Event Date 08/17/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death.

Event Description
Initial reporter indicated that their patient was seen in their clinic and had on a systems test dcdc 7 limit high eri no and normal mode test dcdc 7 limit high eri no. It was additionally reported the patient had drop attack seizures and had been having more drop attacks recently. Last date diagnostics were taken was (b) (6) 2005. Normal mode ok/ok/dcdc 0, systems test ok/ok/dcdc 3. The patient's x-rays were not sent to the manufacturer but the site reported that they reviewed x-rays and there was an obvious break and lead coiled up. The treating physician believed the cause of the patient's lead break was related to a very bad fall related to drop attacks. The patient had their lead replaced but it was not returned to the manufacturer for analysis. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478437
« Last Edit: November 23, 2015, 03:19:17 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #59 on: March 23, 2012, 09:02:57 AM »

Model Number 302-20
Event Date 07/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a vns patient was working in an e. R. And got close to an mri machine while in use. The patient subsequently experienced a sensation of strong stimulation and had a gagging episode for about 20 minutes. The treating physician indicated that both events were believed to be related to vns and that the mri most likely caused the vns to "trigger". As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1478442
« Last Edit: November 23, 2015, 03:19:48 AM by dennis100 » Logged
Pages: 1 [2] 3 4 ... 9   Go Up
Print
Jump to: