Pages: 1 ... 188 189 [190] 191 192 ... 225   Go Down
Print
Author Topic: High Lead Impedance  (Read 531909 times)
0 Members and 33 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5670 on: January 10, 2019, 01:44:31 AM »

Model Number 300-20
Event Date 03/10/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery, high impedance was observed and the patient underwent both generator and lead replacement. Only the explanted generator was returned for analysis. Analysis of generator was completed. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. The physician's office reported that the physician would not remember any further information; therefore, no additional relevant information was able to be obtained.
 
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=3778328
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5671 on: January 11, 2019, 02:05:05 AM »

Model Number 302-20
Event Date 05/24/2007
Event Type  Malfunction   
Event Description
Review of device programming history identified that high impedance (dc dc code - 4) was identified and then fluctuated back down to dc dc code - 3. On (b)(6) 2007, high impedance resulted on system diagnostics (ok/high/4/no). Previously on date of implant, system diagnostics were within normal limits at ok/ok/2/no. Later on (b)(b)(6) 2007, system diagnostics went back down to dcdc=3 but increased again to dcdc=4 on (b)(6) 2007. Later on (b)(6) 2009, system diagnostics were ok/ok/3/no.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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=3771009
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5672 on: January 11, 2019, 02:05:47 AM »

Model Number 302-20
Event Date 03/04/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that pre-operative diagnostics prior to generator replacement resulted in high impedance. During the surgery, a new generator was placed and it was determined that the lead should also be replaced. The lead was also explanted (leaving electrodes). Attempts to obtain additional relevant information have been unsuccessful to date. The explanted generator and lead had not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3718887
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5673 on: January 11, 2019, 02:06:59 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Relevant tests/laboratory data, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Evaluation codes, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history.
 
Event Description
Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.
 
Event Description
It was reported that during generator replacement for end of service, high impedance (9225 ohms) was seen when the new generator was attached to the existing lead. It was reported that interrogation of the device prior to surgery was unsuccessful and the high impedance was not observed until the new generator was attached. The surgeon went to explant the lead and observed that the tubing was "stripped back and exposed down to the wire". The surgeon was unclear if any trauma caused the damage. It was reported that the patient was recently mugged which resulted in bruising; however, it is unknown if this may have caused or contributed to the high impedance. The lead was explanted (leaving electrodes) and a new lead was placed. Diagnostics with the new generator attached to the new lead were within normal limits (1556 ohms). The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 292mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 282mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. One of the broken coil strands was identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. During the visual analysis of the returned 146mm portion the end of the (-) green electrode quadfilar coil appeared to be broken approximately 31mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. With the exception of the observed discontinuities and abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Analysis of the generator was completed on (b)(4) 2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
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=3771292
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5674 on: January 11, 2019, 02:08:01 AM »

Model Number 304-20
Event Date 03/24/2014
Event Type  Malfunction   
Event Description
The patient underwent lead and generator explant surgery (not replaced) and the lead and generator were discarded following surgery. The leads device history record was reviewed and all line items were verified to have been signed off. Additionally, all electrical tests/visual inspections were passed and there were no unresolved issues prior to device shipment.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury. Event date, corrected data: the initial report inadvertently listed the wrong event date.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The physician reported that the device diagnostics on (b)(6) 2014 were within normal limits. It was reported that the patient is developmentally delayed and there is a possibility that the patient may have suffered trauma to the vns system. The patient was referred for x-rays. The physician reported that he did not think x-rays would show anything. The x-rays will not be sent to manufacturer for review. The patient was referred for surgical consult. No surgical intervention has been performed to date. A review of device programming history identified that the high impedance first occurred on (b)(6) 2011 has been intermittent.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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=3762047
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5675 on: January 11, 2019, 02:09:06 AM »

Model Number 304-20
Device Problem High impedance
Event Date 04/01/2014
Event Type  Malfunction   
Event Description
It was reported that the explanted lead and generator were discarded.
 
Event Description
It was reported that the patient underwent full revision surgery. The explanted lead and generator have not been received to date. Device diagnostics with the new lead and generator were within normal limits.
 
Event Description
Additional information was received that the patient has been having 4-5 drop attacks per day. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that high lead impedance was observed for the vns patient¿s device. The patient was subsequently programmed off. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient was reported to be doing well. Review of the available programming and diagnostic history showed the last normal diagnostic results were from (b)(6) 2011. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(4) 2014, it was reported that the patient had been having quite a few seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3770336
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5676 on: January 11, 2019, 02:10:04 AM »

Model Number 300-20
Event Date 04/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance. Diagnostic tests were performed again and still showed high impedance (impedance value ¿ 9358 ohms). The physician intended to have the patient¿s device programmed off. No patient manipulation or trauma was reported. X-rays were taken on 04/01/2014 and were reported by the physician to be unremarkable. X-rays were provided to the manufacturer for further review. Based on the x-ray images provided, an exact cause for the reported high impedance could not be determined. There appeared to be a suspect area that could potentially be causing high impedance; however, this cannot be verified due to the poor image quality. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. X-rays reviewed by 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=3769800
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5677 on: January 11, 2019, 02:11:02 AM »

Model Number 302-20
Event Date 03/25/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient was referred for surgery. Clinic notes dated (b)(6) 2014 note that the impedance was high and that a new lead and generator would be reimplanted in the next few weeks. Clinic notes dated (b)(6) 2014 indicate that the lead impedance is within normal limits. The patient underwent generator and lead replacement on (b)(6) 2014. The generator was replaced prophylactically. The explanted devices are expected to be returned for analysis, but have not been received to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2014, additional information was received: the high impedance was initially seen on normal mode diagnostic testing; however, the dcdc value was not known. The device was not programmed off following observation of the high impedance results. X-rays were not taken. There was patient manipulation or trauma that may have caused/contributed to the high impedance.
 
Event Description
An implant card was received indicating that the generator and lead were replaced due to high impedance (dc dc code - 4). The generator analysis was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. The lead analysis was completed on (b)(4) 2014. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3767348
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5678 on: January 11, 2019, 02:12:04 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Event Description
X-rays were reviewed by manufacturer. No obvious lead breaks or sharp angles were identified on the lead portions that could be assessed. It was reported that no trauma or manipulation is suspected that may have caused or contributed to the high impedance. The generator was not programmed off after observing the high impedance.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed high lead impedance. The patient could no longer feel stimulation. X-rays were taken but have not been provided to the manufacturer for further review to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
The initial mfr. Report inadvertently listed that x-rays had not been received for analysis. The x-rays had been received and review was underway at the time of initial report. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3766168
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5679 on: January 11, 2019, 02:13:09 AM »

Model Number 302-20
Event Date 04/01/2013
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on ((b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc ¿ 7). The neurologist reviewed the patient¿s clinic notes and stated that high impedance was observed during an office visit in (b)(6) 2013. The patient¿s device was not programmed off at that time. The neurologist reported that the patient continues to have seizures and experienced a fall the previous week. The patient was reported to be non-verbal but active, so it is unclear what may have caused or contributed to the high impedance. No known interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the lead prior to distribution.
 
Event Description
The neurologist reported that the high impedance was observed at the patient's first visit with the physician and that device diagnostics with the previous physician in 2011 were within normal limits. The device was programmed off. The neurologist reported that x-rays were taken and that the plan was to leave the device programmed off and observe the patient for four to eight weeks. No surgical intervention have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3761245
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5680 on: January 11, 2019, 02:14:14 AM »

Model Number 300-20
Device Problem High impedance
Event Date 03/05/2014
Event Type  Malfunction   
Event Description
Further information was received indicating that system diagnostics were run on the vns system which returned a low impedance result and that the generator was disabled.
 
Event Description
Additional information was received stating that the vns patient¿s surgery has not been planned and has not occurred to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegation of high impedance was confirmed. Note that portions of the (+) white and (-) green electrode quadfilar coils, the anchor tether and (+) white electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Visual analysis of the returned lead portion found two places of broken coil strands. Both breaks having evidence of stress induced fracture (fatigue appearance). It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of high impedance. The abraded inner tubing openings, exposed coils in adjacent areas, and the tissue-covered (-) green electrode ribbon the condition of the returned lead portions are consistent with conditions that typically exist following an explant procedure. There is no evidence to support the low impedance condition. No other obvious anomalies were noted.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance during an office visit on (b)(6) 2014. The device was subsequently programmed off. The patient was experiencing an increase in seizures above pre-vns levels. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received indicating that the patient underwent generator replacement for end of life on (b)(6) 2014. The implant card noted that the lead impedance was high (>10,000 ohms). The physician reported that the high impedance was observed after the new generator was placed on the existing lead. The new generator was not disabled as the physician believed there were no adverse events reported. The patient is scheduled for lead replacement surgery. No surgical intervention has been performed to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with 1930 ohms. Return of the explanted lead and generator to the manufacturer is expected but it has not been received to date.
 
Event Description
It was reported that full revision surgery is expected but it has not occurred to date.
 
Event Description
The explanted lead and generator was returned to the manufacturer on (b)(6) 2015. Analysis of the lead is underway but it has not been completed to date. Analysis of the generator was completed and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717874
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5681 on: January 11, 2019, 02:15:24 AM »

Model Number 300-20
Event Date 12/23/2013
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that during an office visit on (b)(6) 2014, the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 7035 ohms). The patient reported that he felt stimulation and knew that he had damaged the device. The patient¿s device was subsequently programmed off. It was reported that the patient had a fall that is believed to have caused or contributed to the high lead impedance. X-rays were taken and were reported by the neurologist to be unremarkable. The notes indicate that during an office visit on (b)(6) 2013, the patient reported feeling a tingling sensation 2-3 times a week at his generator site. The neurologist stated that there may have been an issue with the patient¿s electrode as a warning message appeared during the office visit; however, diagnostic results during the office visit showed lead impedance (impedance value ¿ 3601 ohms) within normal limits. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product information was obtained. An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted generator and lead have not been returned to the manufacturer to date.
 
Manufacturer Narrative
Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Date of implant; corrected data: the previous mdr incorrectly reported the implant date. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative
Date of event, corrected data: the initial manufacturer report incorrectly reported the date of event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3766185
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5682 on: January 11, 2019, 02:16:30 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc ¿ 7). The patient¿s device was subsequently programmed off. No patient trauma was reported. The patient was seizure free for over a year until recently when he began having several seizures per month. Clinic notes were received indicating that the no patient or device issues were noted during the patient¿s previous office visit on (b)(6) 2014. The notes state that x-rays were taken and were reported by the physician to be unremarkable. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. No known interventions have occurred to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received stating that the patient¿s increase in seizure was related to a possible device malfunction and high impedance. The increase in seizures was above pre-vns baseline levels and all of the patient¿s seizure types had increased. X-rays were taken and were reported by the physician to be unremarkable.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3763225
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5683 on: January 11, 2019, 02:17:47 AM »

Model Number 304-20
Event Date 02/12/2014
Event Type  Malfunction   
Event Description
The patient's treating physician reported that the patient has not been in the clinic and he has no further information.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). X-rays were taken the same day and were provided to the manufacturer for review. Based on the x-rays received, the cause of the high lead impedance indicated is due to the presence of the gross lead fracture observed. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3767218
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5684 on: January 11, 2019, 02:19:12 AM »

Model Number 302-30
Event Date 03/24/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead explant. A new vns system was not implanted. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on 08/06/2014. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 08/11/2014. Abraded openings were noted on the outer and the inner silicone tubing. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Also, the negative coil shows that a stress-induced (fatigue) fracture occurred in one strand of the quadfilar coil. However, due to pitting and mechanical distortion (smoothed surfaces) the fracture mechanism of the other strands cannot be determined. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The physician programmed the device off on (b)(6) 2014. The physician reported that x-rays were performed and the patient was referred to surgery. The plan is to have the device explanted if insurance approves. Surgical intervention has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3762087
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5685 on: January 11, 2019, 02:20:16 AM »

Model Number 303-20
Event Date 03/18/2014
Event Type  Malfunction   
Event Description
A physician reported high lead impedance. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to the manufacturer to date.
 
Event Description
Additional information was received that the lead was returned to the manufacturer for evaluation. During the visual analysis of the returned 27mm portion the (-) green electrode tri-filar coil appeared to be broken approximately 14mm from the distal end of the anchor tether. A portion of the coil appeared to be dissolved. Scanning electron microscopy was performed on the (-) green electrode tri-filar coil break and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type and evidence of electro-etching on the coil surface. Scanning electron microscopy was performed on the spot-weld / slug area and identified evidence of electro-etching and pitting on the weld connection. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The puncture marks found on the bilumen tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the bilumen tubing. During the visual analysis of the returned 27mm portion what appeared to be a remnant of dried body tissue was observed on the surface of the ribbon. This condition may have prevented the (-) green electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the partially tissue-covered (-) green electrode ribbon the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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=3759174
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5686 on: January 11, 2019, 02:21:07 AM »

Model Number 300-20
Event Date 03/25/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (dc dc ¿ 7). The patient was last seen in (b)(6) 2013 and diagnostic results showed lead impedance within normal limits (dc dc ¿ 1) at the time. There were no reports of falls, adverse events, or contributory events that could have led to patient's high impedance. The neurologist elected not to have the patient¿s device programmed off. X-rays were taken and were reported to show no lead discontinuity. Replacement surgery was scheduled but canceled per the patient¿s request.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. 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=3758923
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5687 on: January 11, 2019, 02:22:56 AM »

Model Number 302-20
Event Date 03/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality specifications were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. The explanted devices were returned for analysis. Analysis was completed on the generator. The device performed according to functional specifications. Analysis concluded that no abnormal performance or any other type of adverse condition was found with the generator. Analysis of the lead has not been completed to date.
 
Manufacturer Narrative

Event Description
An analysis was performed on the returned lead portions. During the visual analysis of the returned 200mm portion quadfilar coil 1 appeared to be broken approximately 174mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the second broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The two remaining broken coil strands were identified as being pitted with mechanical damaged which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It is unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. It was later reported that x-rays were performed and would be sent to manufacturer for review. It is unknown if the device was programmed off per manufacturer's recommendations. No surgical intervention has been performed to date. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Attempts for additional information have been unsuccessful.
 
Event Description
X-rays were received and reviewed by manufacturer. Based on the x-rays received, the cause for the reported events are unable to be determined. There was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. As the lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Due it image quality the lead that were difficult to visualize and fully assess.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3757980
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5688 on: January 11, 2019, 02:23:54 AM »

Event Date 03/21/2014
Event Type  Malfunction   
Event Description
During generator replacement for end of service, high impedance (dc dc code - 7) was obtained with the new generator attached to the existing lead. It was reported that the high impedance was not observed prior to this as the explanted generator was unable to be interrogated due to being at end of service. The surgeon tested the newly implanted generator which showed the new generator was functioning as intended. It was reported that diagnostics on the explanted generator in (b)(6) 2013 resulted in "limit". It is unknown whether or not this is meant as near end of service or is related to high impedance. No information was received indicating whether or not the lead was also replaced. Attempts to obtain additional relevant information 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=3758934
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5689 on: January 12, 2019, 12:06:40 AM »

Model Number 304-20
Event Date 03/05/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
The patient underwent lead replacement surgery. The explanted generator was returned for analysis; however, despite attempts to have the lead returned for analysis, the lead has not been received to date. Attempts to obtain additional relevant information have been unsuccessful to date. Generator analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Evaluation, correction: it was inadvertently not reported on supplemental report #1 that the lead was discarded.
 
Event Description
It was reported that the lead has been discarded. Analysis of the generator was completed. Review of the internal data shows a change in impedance occurred approximately on (b)(6) 2014 from 2131 ohms to >20000 ohms. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the analysis lab, the battery is partially depleted. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported that during prophylactic generator replacement surgery on (b)(6) 2014, the replacement generator was tested with the existing lead and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). Operative notes stated that the surgeon did not observe any breaks in the lead or any leakage through the insulation at the chest wall pocket portion of the lead. The patient¿s device was not programmed on during the procedure. The operative notes indicate that diagnostics were performed after the patient was closed; therefore, no intraoperative troubleshooting was performed. Notes were received showed normal diagnostic results through (b)(6) 2013. X-rays were taken and were reported in the notes to be unremarkable. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3740315
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5690 on: January 12, 2019, 12:07:43 AM »

Model Number 300-20
Event Date 09/28/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The generator was programmed off on (b)(6) 2014. An emg was performed which showed an immediate drop of electrical load during stimulation which reflects a possible break of the lead. X-rays were taken and sent to manufacturer for review. X-rays did not identify any obvious discontinuities within the vns system. It was reported that surgery is likely; however, surgery has not occurred to date.
 
Event Description
During the product analysis there were no anomalies found with the pulse generator. The generator performed according to functional specifications. During the visual analysis of the returned lead portion, the (+) marked and (-) unmarked quadfilar coils appeared to be broken in the body area of the returned lead assembly. Scanning electron microscopy was performed and identified evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting on both of the broken coils. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded opening found on the (+) inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing. For the observed (-) inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement on (b)(6) 2014. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date. The surgeon indicated that there were white spots on the lead at the contact area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3741207
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5691 on: January 12, 2019, 12:09:12 AM »

Model Number 302-30
Event Date 03/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 04/22/2014. During the visual analysis the (+) white electrode quadfilar coil appeared to be broken approximately 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed identified the area as being mechanically damaged with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy, provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance and the patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. Pre-operative device diagnostics resulted in high impedance. The explanted generator and lead were returned for analysis on (b)(6) 2014. Analysis of the generator was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found; however, during decontamination an elective replacement indicator was observed. Analysis of the lead is underway, but has not been completed to date. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3751483
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5692 on: January 12, 2019, 12:10:02 AM »

Model Number 302-30
Event Date 03/18/2014
Event Type  Malfunction   
Event Description
The patient underwent a vns generator replacement surgery. High impedance was still present after the generator was replaced. Surgery to replace the lead has not occurred to date. The explanted generator was discarded by the facility, so product return to the manufacturer is not expected. No additional pertinent information has been received to date.
 
Event Description
The patient has been referred for surgery. No known surgery to replace the lead has occurred to date.
 
Event Description
During the periodic programming history review, programming history was reviewed for this patient's generator. The programming history shows that high impedance was observed on (b)(6) 2014.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The physician programmed the generator off after observing the high impedance. The physician requested testing be performed. The patient was not referred for x-rays. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.
 
Event Description
Additional information was received that the patient is undecided if she will pursue surgery. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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=3753871
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5693 on: January 12, 2019, 12:10:47 AM »

Model Number 302-20
Event Date 03/24/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient was experiencing an increase in seizures possibly due to end of service. The patient¿s device was tested and diagnostic results revealed high lead impedance. The battery status is unknown. The patient¿s device was subsequently programmed off. It is unclear whether trauma caused or contributed to the event. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discards explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3756978
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5694 on: January 12, 2019, 12:12:10 AM »

Model Number 302-20
Device Problem High impedance
Event Date 06/23/2005
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7; eos - yes). It was reported that the patient was referred to surgery. The device was not programmed off after observing the high impedance. Clinic notes dated (b)(6) 2014 note that high impedance was observed and that the vns is still working. Device settings were adjusted. The notes indicate that the patient was referred for surgery. The physician's office reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. No x-rays were performed. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative
Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.
 
Event Description
The generator was replaced on (b)(6) 2014. The patient had a full replacement on (b)(6) 2015. The surgeon stated he observed an obvious break in the lead wire approximately 3-4 inches away from the generator but did not know what might have caused it. The explanted lead has not been received to date.
 
Event Description
High impedance was detected on (b)(6) 2015, and a decrease in seizure control was reported. The patient has been referred to a surgeon for lead revision, but no surgical intervention has occurred to-date. Clinic notes received indicate that systems diagnostics was performed with lead impedance >=10000 ohms. The output current was lowered from 2. 0 ma to 1. 5 ma. The patient's generator was replaced on (b)(6) 2015.
 
Event Description
The generator and lead were received for analysis on 01/15/2016. Product analysis for the lead was completed and approved on 02/02/2016. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 81mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 37mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having extensive pitting which prevented identification of the coil fracture. The remaining two broken coil strands were identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. Pitting and residual material was observed on the coil surface. During the visual analysis of the returned 135mm portion the connector ring quadfilar coil appeared to be broken approximately 20mm from the end of the cut / torn outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having extensive pitting which prevented identification of the coil fracture. The remaining broken coil strand was identified as being mechanically damaged (smooth surfaces) with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Product analysis for the generator was completed and approved on 02/04/2016. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.
 
Event Description
Additional information was received indicating that the vns patient underwent surgery on (b)(6) 2014. During the procedure, the patient¿s generator was replaced due to end of service. The replacement generator was tested with the existing lead and system diagnostic results showed lead impedance within normal limits. The lead was not replaced. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Age at time of event, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Date of event, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Operator of device, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Evaluation codes, conclusions, corrected data: supplemental manufacturer report #01 inadvertently did not update this information to report user error caused event.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently reported that the patient's generator was replaced on (b)(6) 2015, when the replacement surgery occurred on (b)(6) 2015. Relevant tests/laboratory data, corrected data: the diagnostics performed on (b)(6) 2014 were inadvertently not provided in detail as provided by the clinic notes. The diagnostics also were inadvertently not identified as systems diagnostics. Brand name, corrected data: the brand name of the device was inadvertently reported for the generator in supplemental mfr report#01. Type of device, corrected data: the type of the device was inadvertently reported as the generator in supplemental mfr report#01 when intended to be for the lead. Model#, serial#, lot#, expiration date, corrected data: the device product information was inadvertently reported for the generator in supplemental mfr report#01 when intended to be for the lead. Explanted date, corrected data: the device was inadvertently reported explanted in supplemental mfr report#01 when intended to be for the lead, which has not been explanted to-date. Device evaluation, corrected data: the suspect device was inadvertently reported as the generator, when intended to be for the lead, which has not been returned as it has not been explanted to-date. Device manufacture date, corrected data: the suspect device manufacture date was inadvertently reported for the generator, when intended to be for the lead.
 
Event Description
The septum and setscrew were not returned with the generator. The end of service condition of the generator was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Describe event, corrected data, mdr #3 inadvertently stated that patient had generator replaced (b)(6) 2015 instead of (b)(6) 2014.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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=3757508
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5695 on: January 12, 2019, 12:13:06 AM »

Model Number 302-20
Event Date 12/04/2013
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results showed high lead impedance during an office visit on (b)(6) 2014. The patient¿s device was subsequently disabled. Patient manipulation is not believed to have caused or contributed to the high impedance; however, the physician noted that the patient experienced trauma from drop seizures. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The x-rays were sent to the manufacturer for further review. Based on the x-ray images provided, the cause of the high impedance cannot be determined. Due to the quality of the images provided, incomplete pin insertion and lead discontinuity cannot be confirmed. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanting facility discarded the explanted lead; therefore, no analysis can be performed.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. 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=3755702
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5696 on: January 12, 2019, 12:14:00 AM »

Model Number 300-20
Event Date 03/19/2014
Event Type  Malfunction   
Event Description
Product information was received.
 
Event Description
It was reported that during generator replacement surgery due to end of service on (b)(6) 2014, the vns patient¿s replacement generator was tested with her existing lead and diagnostic results revealed high lead impedance (dc dc ¿ 7). Pre-operative diagnostic tests were not performed due to failure to interrogate. The physician cleaned and re-inserted the lead pin into the generator header three times but was unsuccessful. Diagnostic results with the replacement generator and test resistor showed lead impedance within normal limits (dc dc 2). The physician did not replace the lead at the time and left the device programmed off. The patient did not exhibited any symptoms that would suggest high lead impedance. No known interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010. The explanted generator was returned to the manufacturer for analysis. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement on (b)(6) 2014. It was reported that the explanted devices will not be returned for analysis.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient has apparent left vocal cord paralysis (bitonal voice) following explant of the entire lead. No additional relevant information h as been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3755691
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5697 on: January 12, 2019, 12:15:12 AM »

Model Number 300-20
Event Date 03/17/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for x-rays and the device was programmed off after observing the high impedance. It was reported that the radiologist felt that there could be a discontinuity of the lead from his review. X-rays were sent to manufacturer for review. Review of x-rays identified a suspect area at the anchor tethor; however, no obvious lead fractures were seen. The physician reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to lead discontinuity and end of service. The explanted devices were returned to the manufacturer for analysis. No abnormal performance or any other type of adverse condition was found with the pulse generator. The device performed according to functional specifications. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3753833
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5698 on: January 12, 2019, 12:16:01 AM »

Model Number 302-20
Event Date 09/07/2013
Event Type  Malfunction   
Event Description
Data from the generator¿s ram memory was extracted from programming history obtained from the day of revision surgery and revealed that, contrary to the initial report, a high impedance warning was received during the initial interrogation of the patients existing generator in addition to an intensified follow-up indicator (ifi) message (not neos). The data also identified that a >25% change in system impedance was estimated to have occurred on (b)(6) 2013 (pre-change: 2092 ohms, post-change: 11954 ohms) signifying the onset of the high impedance event. This programming history also confirmed that diagnostics performed with the patient new lead and generator was within normal limits.
 
Event Description
It was reported that the patient underwent generator and lead replacement due to high impedance and neos = yes. It was reported that device diagnostics prior to generator replacement were within normal limits, but after the new generator was connected to the existing lead device diagnostics resulted in high impedance. The lead was then replaced. It was reported that there were no x-rays taken and no trauma or injury that was believed to have caused or contributed to the high impedance. It was reported that the explanting facility does not returned explanted devices; therefore analysis will not be performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Event date, corrected data: the initial report inadvertently listed the wrong event date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3746238
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #5699 on: January 12, 2019, 12:17:17 AM »

Model Number 302-20
Event Date 03/06/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently disabled. The patient had been experiencing an increase in seizures. The patient had multiple seizure types and all have increased. X-rays were taken and were reported to be unremarkable. X-rays were provided to the manufacturer for evaluation. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pins appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Based on the images provided, the cause of the high impedance cannot be determined. The entire lead was not visible on x-rays and therefore continuity in the portions of the lead that were not able to be assessed cannot be confirmed. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known interventions have occurred to date.
 
Event Description
Analysis of the returned generator and lead was completed. The generator analysis will be reported in the next quarterly remedial action exemption report. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. A break was identified in one of the lead coils. Abraded openings were noted in the outer silicone tubing resulting in a portion of the positive coil being exposed. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the exposed portion. Scanning electron microscopy images of the broken coil (coil 1) suggest a stress-induced fracture (fatigue) on at least two strands of the quadfilar coil as well as pitting or electro-etching conditions at the break location. Due to pitting and mechanical distortion (smoothed surfaces) the fracture mechanism of the other strands cannot be determined. Also, the broken coil shows what appear to be superficial voids in the vicinity broken coil wires at the mate end. No obvious adverse effect was identified on the device performance as a result of this condition. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Adverse event and/or product problem, corrected data: supplemental mdr #01 inadvertently did not update this field based on the additional information reported in the report. Outcomes attributed to adverse event, corrected data: supplemental mdr #01 inadvertently did not update this field as interventions had taken place. Additional information was received stating that the patient was also hospitalized.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received stating the vns patient was in the hospital when he began experiencing the reported increase in seizures, which was believed to be due to the lead fracture identified during analysis of the returned lead portion.
 
Event Description
It was reported that the patient was scheduled for revision surgery. The patient underwent surgery on (b)(6) 2014. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3740655
Logged
Pages: 1 ... 188 189 [190] 191 192 ... 225   Go Up
Print
Jump to: