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Author Topic: High Lead Impedance  (Read 528553 times)
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dennis100
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« on: April 23, 2017, 01:54:15 AM »

Event Date 05/01/2009
Event Type Malfunction
Event Description
It was reported to the manufacturer that vns pt's device showed high lead impedance during diagnostic testing at an office visit. It is unk when the pt's device diagnostic tests were last within normal limits prior to this office visit. It was indicated that the pt was punched in the chest near the generator with a binder. The pt is still able to perceive stimulation and continues to experience voice alteration with stimulation. The pt's device was not programmed off per physicians discretion. It was also indicated that the pt has been experiencing an increase in seizure activity. It is unk if the increase was above pre-vns baseline level. The increase in seizure activity is believed to be a result of loss of therapy from the high lead impedance event. X-rays were taken of the pt's device and sent to the manufacturer for review. A lead fracture was identified in the neck region of the device, distal to the anchor tether, which is believed to have caused the high impedance event. The pt is being scheduled for revision surgery. Good faith attempts to obtain add'l info regarding the reported event have been unsuccessful to 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=1575842
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dennis100
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« Reply #1 on: April 23, 2017, 01:54:52 AM »

Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected but did not contribute or cause a death or serious injury.

Event Description
It was initially reported that the patient was experiencing some pains in the left part of her throat, which will go up to the head. The patient has always complained of these pains. It was also noted that her impedance was always high, but the physician elected to leave the device on as there were changes as a result. It is unclear at this time what the high impedance values are or any further details regarding the situation as the physician is not available until after the new year. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575857
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dennis100
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« Reply #2 on: April 23, 2017, 01:55:28 AM »

Model Number 300-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported by the patient's neurologist that the patient was seen for her first follow up appointment, since a recent generator revision surgery, and that a system diagnostic test was performed which revealed high lead impedance. The physician indicated that he had received notification from the surgeon who performed the generator replacement that there may be an issue with the lead. The patient was referred back to the surgeon for a consult. Good faith attempts to obtain additional information are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575860
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dennis100
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« Reply #3 on: April 23, 2017, 01:56:07 AM »

Model Number 302-20
Device Problem High impedance
Event Date 12/03/2009
Event Type Malfunction
Event Description
It was reported that the vns pt was seen during a clinic follow up visit, and when the vns device was tested, high lead impedance resulted. The device was programmed off, and the pt was sent for x-rays to evaluate the continuity of the device. X-rays were sent to mfr for review, and there were no obvious lead discontinuities observed, and the lead pin appeared to be fully inserted inside the generator connector block. A suspect area of the lead was noted below the anchor tether and above the tie-down. However, due to poor image quality, this area could not be adequately assessed. Additional info was received revealing that surgery was planned for (b) (6) 2009. The site reported that both the lead and generator were replaced. There was no trauma reported to have occurred prior to the high lead impedance. Good faith attempts to obtain additional info have been made, but have been unsuccessful to date.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no obvious 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=1581629
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dennis100
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« Reply #4 on: April 23, 2017, 01:56:51 AM »

Model Number 302-20
Event Date 09/01/2009
Event Type Malfunction
Event Description
It was initially reported by the physician that his patient showed high lead impedance on system diagnostics test. He stated that this patient is also experiencing increase in depression above pre-vns baseline and the physician believes it is related to vns/high lead impedance event. It was informed to the physician to turn off the patient's device and take x-rays. No patient manipulation or trauma was reported. Physician never performed diagnostics in the past, so it is unknown till what date the device was functioning properly. Good faith attempts to obtain additional information has been unsuccessful.

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=1575865
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dennis100
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« Reply #5 on: April 23, 2017, 01:57:30 AM »

Model Number 302-20
Device Problem High impedance
Event Date 12/02/2009
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
Reporter indicated high lead impedance readings were obtained after a pt's vns was re-enabled following an mri. The pt may have had possible trauma. The vns was disabled. X-rays were reviewed which did not identify any obvious anomalies, but the image quality was poor. It could not be determined if the lead pin was fully inserted into the generator. Vns revision surgery is possible, but has not been scheduled to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581625
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dennis100
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« Reply #6 on: April 23, 2017, 01:58:09 AM »

Model Number 300-20
Event Date 10/20/2009
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
It was reported that the patient was scheduled for surgery due to normal battery depletion and an increase in seizure activity. The generator was not able to be communicated with prior to surgery, due to normal expected battery depletion. During revision surgery, when a new generator was connected to the existing lead, high lead impedance resulted from the system diagnostic test. A pin re-insertion was attempted, and high lead impedance resulted again. The lead was not replaced at that time. The device has not been programmed on, and the neurologist is going to monitor the patient's seizure activity and will decide at a later date if revision surgery will occur to replace the lead. Good faith attempts to obtain additional information are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581631
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dennis100
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« Reply #7 on: April 23, 2017, 01:58:49 AM »

Model Number 303-20
Event Date 12/02/2009
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 suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient was seen for follow up and a system diagnostic test revealed high lead impedance when the vns device was checked. The device was programmed off, and the patient was sent for x-rays to assess the continuity of the device. The x-rays were sent to manufacturer to review and there were no lead discontinuities observed on the portion of the lead that could be visualized and the lead pin appeared to be fully inserted inside the generator connector block. The physician does not believe that there was any trauma or manipulation that contributed to the high lead impedance. Revision surgery is likely to occur.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581633
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dennis100
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« Reply #8 on: April 23, 2017, 01:59:58 AM »

Model Number 302-30
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the patient underwent revision surgery for an unk reason. Follow-up with the physician reveals that the patient had high lead impedance on diagnostics and this was the reason for the revision surgery. Per the physician, the lead was found to be broken near the electrode site at the time of surgery. No patient manipulation or trauma is suspected to have contributed to the lead fracture. X-rays of the patient's device were received and reviewed by the manufacturer, but no anomalies were noted. Attempts for 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=1581641
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dennis100
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« Reply #9 on: April 23, 2017, 02:00:31 AM »

Model Number 302-20
Event Date 12/01/2009
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. The patient's device was programmed off as a precautionary measure. There was no patient manipulation or trauma to the device site that could have contributed to the reported event. Diagnostic test results are indicated to have been within normal limits in (b) (6) 2009. It was also indicated that the patient has been experiencing an increase in seizure activity since (b) (6) 2009. It is unk if the increase is above pre-vns baseline levels. The patient is being scheduled for revision surgery. 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=1581644
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dennis100
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« Reply #10 on: April 23, 2017, 02:01:07 AM »

Model Number 300-20
Event Date 04/01/2005
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 was in surgery for a generator replacement, but when the surgeon attached the new generator to the implanted leads, he got high lead impedance on diagnostics. The surgeon tried attaching the original generator and again got high lead impedance on diagnostics. The surgeon decided at that time to program the patient off and not replace the lead as this was not anticipated at that time. Programming history was reviewed and it was found that diagnostics taken as far back as (b) (6)2005 showed high lead impedance. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581642
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dennis100
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« Reply #11 on: April 24, 2017, 03:23:05 AM »

Model Number 300-20
Event Date 12/01/2009
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 initially reported by the site that the patient showed a high lead impedance warning. It was indicated that the x-ray will be taken and patient was referred to surgeon. Good faith attempts to obtain additional information has been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581035
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dennis100
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« Reply #12 on: April 24, 2017, 03:23:39 AM »

Model Number 302-20
Event Date 12/01/2009
Event Type Malfunction
Event Description
It was initially reported by the nurse from the treating physician's office that the patient showed high lead impedance on system and normal mode test. Last good diagnostics were obtained back in (b) (6)2009. No patient manipulation or traum was reported.

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=1581034
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dennis100
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« Reply #13 on: April 24, 2017, 03:24:18 AM »

Model Number 302-20
Event Date 09/01/2009
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 initially reported by the physician that patient showed high lead impedance with lead impedance 7116 ohms. Normal mode showed ok, lead impedance 6993 ohms. Surgeon had ordered x-rays and treating physician wanted total revision because patient had a hard fall after prophylactic battery replacement surgery in (b) (6)2009. Follow-up with the company rep revealed that the patient had a full revision surgery. It was indicated that the last good diagnostics were obtained at the time of initial battery replacement surgery ((b) (6)2009) which showed everything within normal limit. Company rep stated that the treating physician believed that the reason for high lead impedance was due to a fall which might have caused the lead to break, however, the surgeon indicated that the reason was due to a build of a lot of scar tissue around the electrode region. She indicated that x-rays were taken, and it did not show any lead break. X-rays were not available for manufacture review. Lead was discarded by the hospital since they were torn into pieces at the time of revision surgery. The surgeon did not notice any break on the lead while removing it but he did notice a lot scar tissue around the electrode region. Patient's previous generator programming history was reviewed and it was observed that the dcdc code had dropped to 0. Given the fact that the dcdc code had dropped from 2 to 0, it is suspected that a short circuit condition likely existed which eventually lead to a lead fracture. It is unlikely that fibrosis could be a part of the high lead impedance given that the dcdc code cannot jump from a 0 to such high ohms value unless there is a lead failure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581033
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dennis100
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« Reply #14 on: April 24, 2017, 03:24:51 AM »

Model Number 302-20
Event Date 11/01/2009
Event Type Malfunction
Event Description
Reporter indicated that the pt's device was registering high impedance on a system, and normal mode, diagnostic test. All attempts for further information regarding the high impedance have been unsuccessful to date. X-rays have apparently been taken and are stated to have been sent to the manufacturer for review, but they have not yet been received.

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=1581042
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dennis100
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« Reply #15 on: April 24, 2017, 03:25:28 AM »

Model Number 302-20
Event Date 06/01/2009
Event Type Malfunction
Event Description
Reporter indicated that the pt's device was registering high impedance on both a system diagnostic test and a normal mode diagnostic test. All attempts for further information regarding the issue, and to have a set of x-rays taken for assessment of the lead, have been unsuccessful to date. No further plans for pt care are known currently, as the pt and physician are trying to get the pt's insurance provider to cover the x-rays and possible device replacement.

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=1581044
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dennis100
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« Reply #16 on: April 24, 2017, 03:26:18 AM »

Model Number 300-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a pt presented high lead impedance readings during a recent office visit. The pt as programmed off and it evoke potential measuring was planned. No x-rays have been taken. The pt's programming history was reviewed and it was found that high lead impedance readings were obtained in (b) (6) 2009. No device diagnostics were recorded for sessions prior to the (b) (6) 2009. A battery life calculation was performed using the data available, and it was found that the pt's device is not at end of service. Good faith attempts to obtain additional information are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581046
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dennis100
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« Reply #17 on: April 24, 2017, 03:26:56 AM »

Model Number 302-20
Event Date 11/23/2009
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 through a company representative that a vns pt was referred to the office of the neurosurgeon due to high lead impedance in system diagnostics. Additional information was provided from the office of the neurologist indicating that last known good diagnostics were in (b) (6) 2009. The pt was not seen again until (b) (6) 2009 in which the high lead impedance was read. According to the neurologist, the clinical change in the pt consisted of an increase in seizures and less benefit of using the magnet due high lead impedance with no manipulation or trauma reported by the pt. The clinical change occurred in the past 2-3 months according to the pt's mother and caretaker which coincides with the event. At the moment revision surgery is likely and x-rays were not ordered by the neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581045
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dennis100
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« Reply #18 on: April 24, 2017, 10:47:47 AM »

Model Number 302-20
Device Problems Corrosion; Fracture
Event Date 12/22/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a lead and generator replacement due to high impedance being observed. During the replacement surgery it was noted that the patient's vagus nerve appeared to be damaged. The surgeon reported that the nerve appeared atrophic and discolored immediately around and under the positive and negative electrodes. The surgeon could not determine the cause of the nerve's appearance but noted that the electrodes seemed to be more degenerated than usual. The explanted lead and generator were discarded following the surgery. Therefore product analysis cannot be completed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300905
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dennis100
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« Reply #19 on: April 25, 2017, 01:28:32 AM »

Model Number 302-20
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 a vns pt presented high lead impedance readings (systems 7/limit/high) during a routine visit. There were no pt side effects as a result. An evoke potential test was performed but no issues were identified. There were no reports of pt manipulation or trauma. The pt's programming history available in the in-house database was reviewed however, the results were present for the date of implant and a follow up visit 3 months later. The results were within normal limits. No additional programming/device diagnostic history can be provided by the site as the pt did not attend appointments regularly to have the device checked. X-rays were taken and sent to the mfr for review. No obvious discontinuities or acute angles were observed. The lead pin appeared to be fully inserted. Strain relief was present but not per labeling. No surgery has currently been scheduled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577007
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dennis100
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« Reply #20 on: April 25, 2017, 01:29:20 AM »

Model Number 102R
Event Date 11/19/2009
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no anomalies identified. The lead pins did appear to be fully inserted. It is unknown if the lead pins were fully inserted at the time of the recent surgery in (b) (6)2009, or loosened over time or due to trauma.

Event Description
Reporter indicated high lead impedance readings were obtained for a vns pt at an office visit. The pt had generator replacement surgery previously in (b) (6) 2009; diagnostics at the time were normal. X-rays were reviewed by the mfr and no anomalies were identified. The lead pins appeared fully inserted, suggesting a lead fracture or intermittent contact with the generator header scenario. Vns revision surgery was planned. During the revision surgery, normal vns diagnostics were obtained multiple times after the lead pins were reinserted into the generator. No devices were explanted. It is unknown if the pt has had any recent trauma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578755
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dennis100
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« Reply #21 on: April 25, 2017, 01:30:13 AM »

Model Number 302-20
Event Date 11/17/2009
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 the vns pt was seen for a follow up visit where it was indicated that the pt was no longer feeling stimulation of the device. The pt reported feeling stimulation six weeks ago. A system diagnostic test was performed, which revealed high lead impedance. The physician programmed the device off, and referred the pt for x-rays to evaluate the continuity of the device. The x-rays were sent to mfr for review, where there were no discontinuities observed on the portion of the lead that was able to be visualized. There was no report of pt trauma or manipulation of the device. The pt subsequently had surgery where intra-operative troubleshooting revealed that the lead was problematic. Therefore, the lead and generator were replaced. The explanted portion of the lead, and the generator are expected to be returned to mfr for analysis. Good faith attempts to obtain add'l info from the treating physician are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578751
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« Reply #22 on: April 25, 2017, 01:31:09 AM »

Model Number 302-30
Event Date 11/13/2009
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 at an office visit after the patient had physical therapy performed. The reporter feels the high impedance may be caused by fibrosis at the lead site or a lead fracture. No further information will be available from the reporter. The reporter is aware of the recommendation to disable the vns, but it is unknown if this has occurred. X-rays have been requested, but have not been received to date. Vns revision surgery is planned. Vns revision surgery is likely, but a surgery date has not been set.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1579178
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« Reply #23 on: April 25, 2017, 01:32:11 AM »

Model Number 300-20
Event Date 02/06/2002
Event Type Malfunction
Event Description
It was initially reported via receipt of an implant card, that the vns pt had surgery where both the lead and generator were replaced "prophylactically". Further review of the in-house programming history was performed, which revealed that the pt was seen in (b) (6) 2006, where a system diagnostic test revealed high lead impedance. The device was not disabled when the high lead impedance was observed. There were no other diagnostic test results available. Good faith attempts to obtain additional info from the physician are underway. Good faith attempts to obtain the explanted devices for analysis have been made, but have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575588
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« Reply #24 on: April 25, 2017, 01:33:00 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 a pt presented high lead impedance readings during a routine office visit. X-rays were ordered but not sent to the mfr for review. The pt's device was programmed off and the pt was referred for a surgical consult. There were no reports of pt manipulation or trauma that may have caused or contributed to the high lead impedance readings. Programming and device diagnostics were provided by the site and a battery life calculation performed showed that the device is not at end of service. Good faith attempts to obtain a surgery date and additional info such as x-rays have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575584
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« Reply #25 on: April 25, 2017, 01:33:39 AM »

Model Number 302-20
Event Date 11/03/2009
Event Type Malfunction
Event Description
It was reported that a vns pt underwent a full revision surgery due to high lead impedance. The pt reportedly presented high lead impedance readings (>10,000 ohms) approx 2 weeks prior to surgery. Once the entire device was replaced (lead and generator) the results were within normal limits. The pt's programming history was reviewed and the last acceptable diagnostics recorded were received in 2008. Good faith attempts to obtain additional info including x-rays have been unsuccessful to date. The explanted device has been returned to the mfr for analysis; however, device eval has not been completed.

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=1575587
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dennis100
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« Reply #26 on: April 25, 2017, 01:34:32 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 10/01/2009
Event Type Malfunction
Event Description
It was reported that a vns pt presented high lead impedance readings during a follow up visit after a recent generator revision surgery. The pt was programmed on in the operating room; however, the exact settings were unk. The pt underwent a lead revision surgery and during the procedure, the surgeon noted a lead break. Good faith attempts to obtain additional info have been unsuccessful to date. Attempts to obtain the explanted lead are currently being made.

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=1577002
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dennis100
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« Reply #27 on: April 25, 2017, 01:35:14 AM »

Model Number 302-20
Event Date 10/01/2009
Event Type Malfunction
Event Description
It was initially reported that pt was present in the er because his wound was re-opened and the device was extruding. This event is reported in mfr report # 1644487-2009-02531. Generator and leads were removed and returned to mfr for product analysis. Surgeon does not plan to re-implant the pt right now. Analysis was completed on the lead and a lead fracture was found. Inspection of the lead assembly identified a coil break in the positive coil. Pitting was found on the positive and negative lead coils. Surface pitting on the cut end of the negative quadfilar coil is most likely associated with the generator being left on after the explant procedure. Note that since the electrode array portion was not returned for analysis, an eval and resulting commentary cannot be made on that portion of the lead. No other anomalies were identified in the returned lead portion. Follow up with the treating physician regarding the lead fracture revealed that no pt manipulation or trauma was reported. Physician never performed diagnostics on this pt. Therefore, he wasn't aware of the high lead impedance and does not remember when the last good diagnostics results were obtained. Good faith attempts to obtain additional info has been unsuccessful. Additional info received from the surgeon reveals that the surgeon was not aware of the lead fracture either and he never performed diagnostics tests on the pt prior to explant surgery to confirm if the device was functioning properly.

Manufacturer Narrative
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=1577005
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dennis100
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« Reply #28 on: April 25, 2017, 01:35:59 AM »

Model Number 302-20
Event Date 11/01/2009
Event Type Malfunction
Event Description
It was reported that the patient had high impedance on diagnostics. The patient's parameters were turned down and patient is being monitored. No further information is available at this time. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1576986
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dennis100
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« Reply #29 on: April 26, 2017, 12:08:25 AM »

Model Number 102
Event Date 11/16/2009
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed showed the lead connector pin did not appear to be fully inserted into the generator connector block.

Event Description
Initial reporter indicated that their patient had high lead impedance on their systems test. The last date of within normal limit testing was (b) (6) 2009. It was additionally reported that the patient was hit on chest and presented with a hematoma in that area. The patient is also having an increase in seizures consisting of complex partial - generalized seizures that are not aborted by their magnet. The seizures are not over their pre vns seizure rate. Magnet activations do display in the patient's programming history. It has been recommended to program the vns off and surgical intervention has not been planned at this time. Manufacture reviewed x-rays that show the connector pin is not fully inserted past the connector block. However, because of the limited view provided and the quality of the image, a lead discontinuity cannot be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575411
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