Pages: 1 [2] 3 4 ... 226   Go Down
Print
Author Topic: High Lead Impedance  (Read 533403 times)
0 Members and 30 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #30 on: April 26, 2017, 12:09:31 AM »

Model Number 102
Event Type Malfunction
Event Description
Initial reporter indicated to our country manage in (b) (4) that their pt had high lead impedance and x-rays reviewed showed the lead pin to not be fully inserted into the header of the generator. Revision surgery for exploration is scheduled for (b) (6)2009.

Manufacturer Narrative
Mfr reviewed x-rays of the implanted device. X-rays reviewed by the mfr and the lead pin did not appear to be fully inserted into the header of the generator. The pt's lead pin does not appear to be fully inserted into the header of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578749
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #31 on: April 27, 2017, 12:57:54 AM »

Model Number 300-30
Event Date 11/01/2009
Event Type Malfunction
Event Description
It was reported to the manufacturer that the vns patient's device showed high lead impedance during diagnostic testing at an office visit. The patient recently fell at his place of residency. The patient's physician indicated that the trauma from the fall may have contributed to the high lead impedance event. X-rays were not taken to evaluate the integrity of the device. The patient had a end of service generator replacement surgery in (b) (6) 2009. Diagnostic tests performed with the old generator in (b) (4) 2009 prior to replacement revealed proper device function. Surgery is likely to occur where the connector pin will be reinserted in to the header block or the lead will be replaced to resolve the reported event.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575232
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #32 on: April 27, 2017, 12:58:28 AM »

Model Number 302-30
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that high lead impedance readings were obtained during a surgical consult appointment. The surgeon felt there might be a possible lead micro-fracture and would perform a full revision. There was a report that the pt had recently been in a car accident but it is unk if this affected the device. Pre-operative diagnostics resulted in an impedance value >10. 000 ohms. The generator was replaced and diagnostics were performed again. This time the impedance value was 1883 ohms. The surgeon elected not to replace the lead at this time. Attempts are currently being made to obtain a copy of the surgeon's flashcard to review the diagnostics performed during surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575247
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #33 on: April 27, 2017, 12:59:00 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was initially reported by the physician that the pt showed high lead impedance on a system diagnostics test. X-rays were performed and lead break was found. X-rays were not available for mfr review as per the physician's nurse. Nurse stated that no pt manipulation or trauma was reported. Pt's programming history was reviewed and it was noted that the pt had a continuous fluctuation of dcdc code on system test. This is indicative that a short circuit condition was suspected which eventually lead a lead break. Revision surgery is likely.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1571619
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #34 on: April 27, 2017, 12:59:36 AM »

Model Number 302-20
Event Date 11/01/2009
Event Type Malfunction
Event Description
Reporter indicated high lead impedance readings were obtained for a vns pt at an office visit. The vns was disabled. The pt had fall trauma in (b) (6) 2009, and has a history of falls, but it is not certain if this contributed to the high lead impedance. Two sets of x-rays were reviewed by the manufacturer which did not identify any lead breaks; however, it does appear that the electrodes are not in alignment. In addition, the lead pin was fully inserted. A lead fracture is suspected. Vns lead revision surgery is planned for (b) (6) 2009.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1571643
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #35 on: April 27, 2017, 01:00:07 AM »

Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the pt had high lead impedance on system diagnostics. X-rays were taken and sent to manufacturer for review. Upon review of the x-rays, no anomalies were noted other than the pin possibly not being fully inserted, though this could not be confirmed. The pt has had several atonic seizures (not an increase) which may have caused or contributed to the high impedance. Pt underwent surgery to replace the lead. At the time of surgery, the pin was reinserted, but this did not resolve the high impedance, so the lead was replaced. It was also noted that the anchor tether was not on the nerve as is recommended per labeling. Product has been requested, but has not been returned to manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1571647
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #36 on: April 28, 2017, 12:24:47 AM »

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

Event Description
It was reported to the manufacturer that the vns patient's device showed high lead impedance during diagnostic testing at an office visit. No patient manipulation or trauma to the device site occurred that could have contributed to the reported event. Diagnostic tests performed at initial implantation surgery were within normal limits. It was indicated that the patient's device has been programmed off and that revision surgery is likely. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1551279
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #37 on: April 28, 2017, 12:25:30 AM »

Model Number 300-20
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the surgeon cut the lead during an implant surgery. Pt was scheduled for a generator replacement surgery due to an end-of-service battery. However, entire system was replaced in the or since the surgeon saw the lead broken. It was later indicated that the treating physician had gotten high lead impedance on the pt's follow up visit prior to the surgery. X-rays were received and reviewed by the manufacturer which did not show any lead break. No obvious anomalies were noted on the x-rays. Good faith attempts to obtain additional information has been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1551273
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #38 on: April 28, 2017, 12:26:14 AM »

Model Number 302-20
Event Date 11/02/2009
Event Type Malfunction
Event Description
It was reported that both system and normal mode diagnostics resulted in high lead impedance during a second follow up visit with the current treating neurologist. No pt trauma or manipulation as well as medication changes have been reported. The pt's generator was programmed to 0 ma. Further info from the surgeon's office revealed the pt underwent full replacement surgery of both lead and generator due to the previously reported high impedance. Good faith attempts to obtain product return have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1555939
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #39 on: April 28, 2017, 12:26:55 AM »

Model Number 300-20
Event Date 01/01/2005
Event Type Malfunction
Event Description
Reporter indicated a vns pt was having increased seizures and that the pt has had high lead impedance since 2005. The vns was disabled in 2005 due to the high lead impedance. Vns generator and lead surgery is planned. Attempts for additional info are in progress.

Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1569671
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #40 on: April 28, 2017, 12:27:36 AM »

Model Number 302-20
Event Date 11/05/2009
Event Type Malfunction
Event Description
Reporter indicated a vns patient had high lead impedance readings with diagnostics testing. There has been no known trauma or device manipulation, but the patient does fall. The vns was disable. Vns revision surgery is planned, but a surgery date has not been set.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570354
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #41 on: April 28, 2017, 12:28:13 AM »

Model Number 302-20
Event Date 11/03/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
Clinic notes were received for review that reported the patient was seen in their neurology clinic and it was noted the patient had high lead impedance. Palpation of the stimulator and the leads revealed significant tenderness right at the terminus in the throat just lateral to the larynx. The patient was seen for a surgical consult in relation to their "vns not working" and is scheduled for surgery on (b)(6) 2009. Good faith attempts will be made for the explanted product to be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570355
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #42 on: April 28, 2017, 12:28:55 AM »

Model Number 302-20
Event Date 11/01/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
Initial reporter indicated that the vns pt was seen in clinic and system diagnostic testing yielded high lead impedance 7 limit high. The vns was programmed off and the pt's parents don't want to come back for anything this year. The pt was last seen in (b)(6) 2009, and full diagnostics were done and no issues showed at that time. It was reported that there are major family issues with violence that could have lead to trauma to neck. No x-rays were taken as no intervention is planned. If surgery is performed it will be for a vns explant not replacement. The site will not provide any further details about the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570468
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #43 on: April 28, 2017, 12:29:46 AM »

Model Number 302-20
Device Problem High impedance
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that high lead impedance readings were obtained during a routine office visit. The pt is active in sports but it is unk if any trauma or manipulation may have occurred. The device is not believed to be at end of service. X-rays were taken and sent to the mfr for review. A small portion of the lead appeared to be behind the generator and continuity in that portion of the lead could not be assessed. Strain relief was present but not per labeling. There were no acute angles or lead discontinuities in the visible portions of the lead. Revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570475
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #44 on: April 28, 2017, 12:30:37 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the pt high lead impedance readings were obtained during an office visit. Specific results were not provided. The last acceptable diagnostics were obtained in (b) (6) 2009. There were no reports of any trauma or manipulation. The pt did also have some redness at the generator site with stimulation which resolved once the device was programmed off. X-rays were taken and reviewed by the mfr and no anomalies were observed. The strain relief was not per labeling. A portion of the lead behind the generator could not be assessed. The pt is currently programmed off and will be monitored.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580751
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #45 on: April 28, 2017, 12:31:23 AM »

Model Number 300-20
Event Date 07/12/2004
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Programming history was reviewed from the pt's neurology office by manufacturer revealed the pt had high lead impedance on a systems test and normal mode test. Testing performed on (b) (6) 2009 and (b) (6) 2007 showed 7/limit/high on their systems diagnostic test. Normal mode diagnostics on (b) (6) 2004 also showed 7/limit/high. The pt was sent for revision surgery. The surgeon was not notified of the lead issue prior to the or from his office staff and the pt just had their generator replaced and not programmed on. Surgery will be scheduled at a later date for full revision. The pt's treating neurology office will not release any further info about the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1556525
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #46 on: April 28, 2017, 12:32:20 AM »

Model Number 302-20
Event Date 07/25/2006
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 vns patient had high lead impedance readings with diagnostics. The vns was not disabled, and the reporter is aware of the manufacturer's recommendations to disable the vns when high lead impedance is received. There has been no known trauma or device manipulation. The patient has been referred for x-rays and vns revision. A surgery consult has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570352
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #47 on: April 28, 2017, 12:33:02 AM »

Model Number 300-20
Event Date 10/01/2009
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 by the pt's treating neurologist to our mfg consultant that they had received high lead impedance on a systems diagnostic test output status limit, lead impedance high, dcdc 7, eri yes. The device was not turned off at that time but the site is aware to program the vns off. There was no reported trauma or falls that may have contributed to event. The pt is scheduled for full revision surgery in (b) (6) 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1556040
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #48 on: April 28, 2017, 12:33:48 AM »

Model Number 300-20
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspect, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a patient presented high lead impedance readings during a recent office visit. The patient denies any recent trauma to the device. The device was programmed off and the patient was sent for x-ray. Information was received via clinic notes that the patient also experienced an increase in seizures several months ago ((b) (6)2009). X-ray were taken and sent to the manufacturer for review and no acute angels or obvious discontinuities were observed. There was a portion of the lead behind the generator that could not be assessed. The lead pin was fully inserted into the connector block. There was no strain relief present. Both the positive and negative electrodes did not appear to be properly aligned with the vagus nerve suggesting possible electrode/nerve detachment. The patient has been referred for revision surgery later this month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580795
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #49 on: April 28, 2017, 12:34:56 AM »

Model Number 302-20
Device Problems Bent; High impedance
Event Date 11/03/2009
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. Results - x-rays reviewed by mfr, no gross lead discontinuities visualized. In the ap chest view, near the generator header an acute angle in the lead body was observed only based on that one view. Conclusions - device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Initial reporter indicated to our europe office that they had a pt that did not feel his magnet activations and upon interrogation had high lead impedance on their systems and normal mode testing eri no. X-rays were received for review. Based on the x-rays reviewed, there are no obvious anomalies that could be contributing to the system diagnostic result of dcdc=7 limit high. However, in the ap chest view an acute angle was observed in the lead body near the generator header. It cannot be determined if this acute angle is contributing to the dcdc=7 limit high. A lead discontinuity cannot be ruled out. No other obvious anomalies were observed in the portions of the lead visualized that could be contributing to the reported dcdc=7 limit high result. The pt did not have any fall or injury preceding the high impedance being discovered. At this time unk if any interventions are planned and if the vns is programmed on or off.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1569663
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #50 on: April 28, 2017, 12:35:46 AM »

Model Number 300-20
Device Problem High impedance
Event Date 11/17/2009
Event Type Malfunction
Event Description
It was reported that a vns patient had been hospitalized due to an increase in seizures and the patient's pre-vns seizure baseline was unknown as the patient was new to the treating neurologist. Furthermore, during an office visit system, diagnostics resulted in high lead impedance. X-rays were ordered by the neurologist and were evaluated by the manufacturer. The review of the patient's x-rays indicated the generator was able to be visualized. The lead connector pin appeared to be fully inserted into the generator connector block, the generator placement appeared normal, and the filter feed-throughs appeared intact. The lead body was able to be visualized and no obvious discontinuities or acute angles were observed. Additionally, there is a portion of the lead body that is located behind the generator which is not able to be assessed. At the moment, no patient trauma or manipulation has been reported and revision surgery is likely.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570349
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #51 on: April 28, 2017, 12:36:38 AM »

Model Number 302-20
Device Problem High impedance
Event Date 11/10/2009
Event Type Malfunction
Event Description
It was reported that system diagnostics resulted in high lead impedance during, a follow up visit with the treating neurologist. The patient's generator was programmed off and x-rays were ordered by the neurologist. X-rays were received and evaluated by the manufacturer which revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The lead wires were unable to be assessed if intact at the connector pin. The lead connector pin appeared to be fully inserted into the generator connector block. The portion of the lead behind the generator could not be assessed for lead discontinuities. No acute angles or discontinuities were observed in the visualized portion of the device, though a suspect area was identified in the portion of the lead between the clavicle and the generator. Additional information was received from the surgeon's office indicating the patient underwent lead replacement surgery due to the previously reported high lead impedance. Good faith attempts to obtain product return have been unsuccessful to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570348
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #52 on: April 28, 2017, 12:37:26 AM »

Model Number 302-20
Event Date 10/01/2009
Event Type Malfunction
Event Description
It was reported that the vns pt was seen for follow up and high lead impedance resulted from a system diagnostic test. The physician programmed the device off and referred the pt for x-rays. X-rays were sent to mfr for review where the lead appeared to have a slight kink just above the tie-down, which was located below the anchor tether in the neck. In addition, there were two suspect areas of the lead visualized in the pa chest views received. The first suspect area was located just below the positive electrode where a possible lead discontinuity was observed. The second suspect area was located just above the tie-down where the lead appears to have a kink, where there is a second possible discontinuity observed. The c-spine neck views were inconclusive in revealing lead discontinuities due to the x-ray quality and resolution. The lead pin appeared to be fully inserted inside the generator. The pt has been referred to a surgeon where revision surgery is likely to occur.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. Review of x-rays by the mfr revealed two suspect areas where the lead appeared to have two possible discontinuities. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570473
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #53 on: April 28, 2017, 12:38:22 AM »

Model Number 302-30
Event Date 10/20/2009
Event Type Malfunction
Event Description
It was initially reported that the pt had generator revision due to unk reasons. The pt had her generator replaced, and diagnostics performed in the operating room were within normal limits. The pt was said to have an increase in seizures while in the hospital recovering, so diagnostics were again performed, which resulted in high lead impedance. The diagnostics initially indicated 3100 ohms for the impedance value, but when ran add'l times, the impedance value increased in >10,000 ohms. The pt's settings were decreased from 0. 75ma to 0. 50ma and 0. 25ma, and it did not resolve the impedance value. Later it was indicated that the pt was seen on (b) (6) 2009, which the pt reported a "vibration" on the left side of the chest and shoulder and that she could feel it stimulating "internally and externally. " diagnostics were performed at that time, which were within normal limits. When the pt returned to the office in (b) (6) 2009, diagnostics were performed due to the continued "vibrations," which resulted in high lead impedance. The pt was disabled at this time. At a follow-up appointment on (b) (6) 2009, the pt's device was turned back on to 0. 50ma due to unk reasons. Diagnostics were again performed, which still resulted in high lead impedance. The pt was referred for surgery due to high lead impedance previously observed. The pt had x-rays taken prior to surgery and was said to be fine with no apparent fractures. The x-rays were not sent to the mfr for review and the mfr was not aware of the high impedance at that time. The pt was admitted to the hospital because she was having a lot of seizures, which is their protocol. The leads were not replaced at the time of surgery since there was not enough info to support lead issue. It was noted that prior to the surgery, diagnostics were performed, which resulted in high lead impedance. X-rays of pt that were taken on (b) (6) 2009, (b) (6) 2009 and (b) (6) 2009 were sent to the mfr for review. The x-rays taken on (b) (6) 2009 and (b) (6) 2009, which had the initial generator were assessed. Based on the x-rays received, there were no discontinuities visualized on the lead portions which could be contributing to the reported high lead impedance, but due to the availability of one view and image quality, the entire device could not be completely assessed. The x-rays taken on (b) (6) 2009 were assessed, which had the replacement generator implanted. Based on the x-rays received, there were no discontinuities visualized on the lead portions which could be contributing to the reported high lead impedance, but could not be confirmed due to image quality of the x-rays. In all x-rays reviewed, the pin appeared to be fully inserted into the generator. The pt has been referred for revision surgery.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570478
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #54 on: April 29, 2017, 12:05:07 AM »

Model Number 302-30
Event Date 03/01/2008
Event Type Malfunction
Event Description
Reporter indicated that a system diagnostic test showed high lead impedance. It was reported t hat the pt had recently slipped and fallen, and then within a week of that incident the pt no longer felt vns stimulation and experienced a change in mood. The physician attributed both of these events to loss of therapy due to high lead impedance. X-rays were reviewed by the mfr. The electrodes did not appear to be in the typical orientation, although this could be due to pt anatomy. It was also noted that the strain relief bend was inadequate and the tie-downs were not placed according to recommendations in labeling. Additionally, due to quality of the x-rays, it could not be confirmed that the lead pin was fully inserted past the connector block. Revision surgery is likely.

Event Description
Information was received on 08/16/2016 indicating that the patient had declined to undergo lead revision surgery and had their generator programmed off. The generator was programmed off five years ago according to the physician; a specific date was not available. Diagnostic information confirmed that the patient's generator indicated high impedance was present.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. Results: x-rays reviewed by the mfr, no gross lead discontinuities visualized. The electrodes were not in typical orientation and the strain relief bend appeared inadequate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1023674
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #55 on: April 29, 2017, 12:06:31 AM »

Model Number 302-20
Event Date 03/05/2008
Event Type Malfunction
Event Description
Reporter indicated that diagnostic tests indicated high lead impedance. It was reported that the pt had experienced an increase in seizures, which were at pre-vns baseline levels. It was also reported that the pt falls "quite a bit". X-rays were reviewed by the mfr, and it could not be confirmed that the lead pin was fully inserted. Additionally, the strain relief was not placed according to labeling with a sharp angle below the positive electrode, no tie-downs were visible, and the electrodes did not appear to be in the typically observed orientation. Revision surgery is likely.

Manufacturer Narrative
Method - mfr reviewed x-rays of implanted device. Results - x-rays reviewed by the mfr, although no gross lead discontinuities visualized, it could not be confirmed that the lead pin was fully inserted, the strain relief appeared in adequate, no tie downs were visible, and the orientation of the electrodes appeared atypical. Conclusions - device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022732
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #56 on: April 29, 2017, 12:07:41 AM »

Model Number 302-20
Event Date 02/15/2008
Event Type Malfunction
Event Description
Reporter indicated that the patient was scheduled for surgery consultation due to high impedance on system diagnostic test. X-rays were reviewed by the manufacturer; the lead body was visible and no gross lead fracture was found. The entire lead could not be assessed because there was a portion of the lead that was behind the generator. There were two tie downs present; one was no longer attached to the leads but appeared to be free floating. The lead electrodes were not aligned in the typically observed vertical fashion. This may be due to patient's anatomy or may be due to the electrodes not being properly connected to the vagus nerve. This anomaly may possibly contribute to the high impedance readings. Further follow up indicated that surgery had taken place. The manufacturer was informed that, "the negative electrode was not attached to the vagus nerve. Only the positive electrode and anchor tether were attached. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014329
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #57 on: April 29, 2017, 12:09:07 AM »

Model Number 300-20
Event Date 03/12/2008
Event Type Malfunction
Event Description
Initial reporter indicated that the pt went to the or for surgery to have their generator replaced for end of battery life. High impedance on a systems test was noted in the or after replacement of the generator. The pt was scheduled at a later date for lead and generator replacement surgery. No lead break was visualized on films reviewed by the surgeon preop or documented seen in the or. It was noted preop the pt's lead was seen to be protruding laterally. There was no report of a fall or injury preceding the high impedance event. Device malfunction is the suspected cause of the high impedance event. The explanted product will not be returned for analysis.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1036484
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #58 on: April 29, 2017, 12:11:27 AM »

Event Date 02/19/2008
Event Type Malfunction
Event Description
Reporter indicated a vns patient presented at an office visit with high lead impedance. The physician also indicated the pt has not received any benefit from the vns therapy system. X-rays were taken and sent to the manufacturer for review. A gross lead fracture was visualized prior to the lead bifurcation. Follow-up with the physician revealed the pt has no axial body tone and cannot sit up. The pt is constantly falling over in her chair and the falls are bad. The physician believes one of the falls could have caused or contributed to the lead break. The physician also believes the lack of efficacy is due to the pt not receiving therapy because of the lead fracture. Good faith attempts to obtain additional info have been unsuccessful to date.

Event Description
Additional information was later received from the np who saw the patient in the clinic on (b)(6) 2012. The patient will be explanted (with no specific date known yet) due to patient not responding. The np again reported that the patient's vns was turned off a while ago, and the mother does not want the patient implanted anymore. Attempts for product information have been unsuccessful to date. Although explant surgery is likely, it has not occurred to date.

Event Description
Additional information was received from the company representative reporting that the patient's treating neurologist informed the surgeon in a letter that the patient had not experienced any significant change in seizures using either vns or medication. (although, it is previously known that the device was turned off on (b)(6) 2008. ) the letter also stated that the seizures have not gotten worse, and that the patient was discontinued off of medications. The patient is autistic and keeps grabbing at her generator and the mother would rather have the entire vns system out. At this time, it appears that the patient will have a generator and lead explant, however it has not occurred to date. Clinic notes dated (b)(6) 2012, were received from the referring neurologist's office which reported that the request to have her vns removed was furnished previously bus has not been acted on by her mother. She is currently on no medications having self-discontinued her medications. Her mother states that she has tremors throughout the day and drop attacks with inconsistent history stating occasionally four per week or four per day. The mother requests return to medication because she feels the patent has had some effect in the past.

Manufacturer Narrative
Patient identifier, corrected data: the initial report inadvertently did not report this information. Dave of event, corrected data: the initial report inadvertently reported the date incorrectly. Suspect device implant date, corrected data: the initial report inadvertently did not report the date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015917
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #59 on: April 29, 2017, 12:13:04 AM »

Model Number 302-20
Event Date 03/01/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that patient was in the hospital for three weeks and in that time an external defibrillator was used. Subsequent diagnostics testing revealed high lead impedance, indicating a lead malfunction. Patient later underwent a full revision surgery. Explanted lead and generator were returned to manufacturer, however, that analysis is not yet complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1037190
Logged
Pages: 1 [2] 3 4 ... 226   Go Up
Print
Jump to: