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Author Topic: High Impedance  (Read 680051 times)
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dennis100
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« Reply #7260 on: May 10, 2019, 11:36:09 PM »

Model Number 304-20
Device Problem Fracture
Event Date 03/15/2019
Event Type  Malfunction   
Event Description
Patient underwent full revision (replacement of the lead and generator) due to high impedance lead replacement and prophylactic generator replacement. The explanted product has not been received to date; however, the explanting facility is known to be a no return site, as they typically discard explanted product. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8495678
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dennis100
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« Reply #7261 on: May 10, 2019, 11:36:49 PM »

Model Number 304-20
Device Problem Fracture
Event Date 02/22/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was going to have their generator replaced for an unknown reason. Information was later received that the replacement would be due to prophylactic reasons, neos, and that the patient was "on a rapid cycle protocol + high lead impedances. No known surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8538550
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dennis100
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« Reply #7262 on: May 10, 2019, 11:37:34 PM »

Model Number 304-20
Device Problem High impedance
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
The physician reported a high impedance warning message on patient's vns system. The interrogation showed that the generator's output current was not being delivered, and that the impedance was high. The physician performed x-rays and found no issues. Ap and lateral neck and chest x-rays were received and reviewed regarding the reported high impedance. Based on the images provided, the feedthrough wires integrity could not be assessed at the connector pins, due to the angle of the generator and quality of the image. However, the lead pin appeared to be fully inserted through the connector block. The device was placed in the patient¿s left chest per labeling, and the lead was observed in the neck and chest. Portions of the lead were not visible due to poor image quality and therefore could not be assessed. Due to the image quality, the integrity of the lead wires at the connector pin was unable to be assessed. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. There was a portion of the lead that appeared to be placed behind the generator with no visualization of damage; however, the visibility of the x-ray was poor in this region. The patient underwent lead revision surgery, and it was noted that during surgery lead pin re-insertion was attempted; however, the high impedance still remained after pin re-insertion. It was decided that the lead would be explanted and replaced. It was reported that the high impedance resolved once the lead was replaced. The surgeon visually inspected the explanted lead and did not see any issues with the lead. The explanted product has not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8510231
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dennis100
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« Reply #7263 on: May 10, 2019, 11:38:20 PM »

Device Problem Fracture
Event Date 08/01/2018
Event Type  Malfunction   
Event Description
An implant card was received confirming that a patient underwent a full lead revision procedure due to high impedance. The surgeon does not have an assessment on the cause for high impedance, as the lead did not appear to be broken. The leads were initially replaced; however, the high impedance was still registering on the patient¿s vns system, while the old generator was implanted with the new leads. The surgeon attempted several lead pin reinsertions and ran a diagnostics with the test resistor inserted, but the high impedance did not resolve. It was noted that the problem fixed when the surgeon changed out the generator and rebooted the tablet. It was mentioned that during pin re-insertion attempts the header was inspected for possible obstructions, the setscrew was backed out adequately, and the surgeon heard the clicks when tightening the setscrew with the screwdriver. Additionally, it was noted that the surgeon visually inspected the lead for breaks in the system, and that upon visual inspection no breaks or fractures were observed. The high impedance discovered on the generator has been reported in mfg report # 1644487-2019-00674. The explanted product has not been received to date, and it was noted that the hospital does not have the device available for return to the manufacturer. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8493519
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dennis100
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« Reply #7264 on: May 10, 2019, 11:39:11 PM »

Model Number 1000
Device Problem High impedance
Event Date 03/26/2019
Event Type  Malfunction   
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.
 
Event Description
It was reported that high impedance was detected on the patient's generator and the generator output currents were subsequently turned off. While the patient's vns generator was intentionally disabled due to high impedance, the patient experienced an increase in seizure frequency. It was reported that the patient had scratched their neck, no other known trauma or manipulation has occurred to date. The patient did not experience any known adverse events or pain associated with the high impedance. The patient had x-rays performed, and per the physician, there were no abnormalities shown on the patient's x-rays. A review of the device history records for the generator showed that the generator passed all quality tests and functional specifications prior to distribution. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician's manual, high lead impedance (>/= 5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Additional investigation is underway. No relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8539871
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dennis100
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« Reply #7265 on: May 10, 2019, 11:39:56 PM »

Model Number 302-30
Device Problem Fracture
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
It was reported that the patient¿s output current is low and impedance is high. The nurse checked the patient again with another device and still received same message. The patient was having no symptoms so they decided to leave the device as is. No surgical intervention has occurred to date. No additional relevant information has been received to date. At this time no surgery is planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506341
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dennis100
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« Reply #7266 on: May 10, 2019, 11:40:34 PM »

Model Number 304-20
Device Problem High impedance
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was detected on the patient's generator. It was reported that the lead impedance had gradually increased. Multiple attempts have been made to obtain additional information regarding the reported high impedance; however, further relevant information has not been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8500711
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dennis100
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« Reply #7267 on: May 10, 2019, 11:41:12 PM »

Model Number 1000
Device Problem High impedance
Event Date 03/27/2019
Event Type  Malfunction   
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8531018
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dennis100
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« Reply #7268 on: May 10, 2019, 11:41:53 PM »

Model Number 1000
Device Problem High impedance
Event Date 04/12/2019
Event Type  Malfunction   
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.
 
Event Description
It was reported that the patient had high impedance when interrogated. When interrogated again, the patient¿s impedance was normal. The device history records were reviewed for the generator. The device passed all specifications prior to distribution. No x-rays have been received to date. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generators compared to those reported by model 103-106 generators. As indicated in the physician's manual, high lead impedance (>/=5300 ohms), in the absence of other device related complications, is not an indication of a lead or generator malfunction. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8544031
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dennis100
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« Reply #7269 on: May 10, 2019, 11:42:36 PM »

Model Number 302-20
Device Problem High impedance
Event Date 04/02/2019
Event Type  Malfunction   
Event Description
It was reported that there was high impedance on a patient¿s device. The patient had a replacement surgery due to battery depletion. High impedance was only seen on the new generator as the old generator was unable to be interrogated. Troubleshooting was performed such as re-inserting the pin, ensuring no debris, keeping the screwdriver in set screw. The surgeon felt the patient was not in good enough health to replace the lead so the physician will speak with the patient and possibly replace in the future. The surgeon did not notice any fracture in the lead prior to surgery, and he would get another x-ray after the surgery. It was noted that a generator test on the new generator was not performed as a kit was not available to test the generator. Lead replacement surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8554649
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dennis100
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« Reply #7270 on: May 10, 2019, 11:43:18 PM »

Model Number 302-20
Device Problem Fracture
Event Date 03/19/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was detected on the patient's generator. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8489983
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dennis100
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« Reply #7271 on: May 10, 2019, 11:44:06 PM »

Model Number 303-20
Device Problem Fracture
Event Date 03/15/2019
Event Type  Malfunction   
Event Description
The physician reported a high lead impedance event after performing a system diagnostics test which resulted in high lead impedance and low output current warning messages on the patient's vns device. The patient was later seen back in office, and the impedance value dropped to normal limits; however, the output current was reported to still register as ¿low¿ even though the lead impedance reported ¿ok. ¿ this low output current condition was the result of the generator's inability to deliver the programmed output current due to "increased" impedance. Although the impedance was not registering as "high," the impedance value fell within the higher limits of "normal/ok" impedance, which in parallel with higher output current settings can result in a "low¿ output current condition. The physician had x-rays performed and it was determined that the lead was intact per summary. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8535813
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dennis100
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« Reply #7272 on: May 10, 2019, 11:44:43 PM »

Model Number 302-20
Device Problem High impedance
Event Date 03/07/2019
Event Type  Malfunction   
Event Description
An implant card was received which reported that the patient underwent a generator and lead replacement surgery due to high impedance. No products have been received by the manufacturer to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8470906
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dennis100
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« Reply #7273 on: May 10, 2019, 11:45:27 PM »

Model Number 103
Device Problem High impedance
Event Date 08/01/2018
Event Type  Malfunction   
Event Description
An implant card was received confirming that a patient underwent a full lead revision procedure due to high impedance. The surgeon does not have an assessment on the cause for high impedance, as the lead did not appear to be broken. The leads were initially replaced; however, the high impedance was still registering on the patient¿s vns system, while the old generator was implanted with the new leads. The surgeon attempted several lead pin reinsertions and ran a diagnostics with the test resistor inserted, but the high impedance did not resolve. It was noted that the problem fixed when the surgeon changed out the generator and rebooted the tablet. It was mentioned that during pin re-insertion attempts the header was inspected for possible obstructions, the setscrew was backed out adequately, and the surgeon heard the clicks when tightening the setscrew with the screwdriver. Additionally, it was noted that the surgeon visually inspected the lead for breaks in the system, and that upon visual inspection no breaks or fractures were observed. A device history record review of the generator indicated that all quality inspections were performed and passed. The lead fracture has been reported in mfg report # 1644487-2019-00640. The explanted product has not been received to date, and it was noted that the hospital does not have the device available for return to the manufacturer. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8493520
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dennis100
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« Reply #7274 on: May 10, 2019, 11:48:17 PM »

Model Number 302-20
Device Problem Fracture
Event Date 03/19/2019
Event Type  Malfunction   
Event Description
It was reported in clinic notes received for the patient¿s replacement that they had high lead impedance. The patient was referred for x-rays. No x-rays have been received by livanova to date. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506426
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dennis100
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« Reply #7275 on: May 10, 2019, 11:48:55 PM »

Model Number 300-20
Device Problem High impedance
Event Date 03/25/2019
Event Type  Malfunction   
Event Description
Patient presented with high impedance. There was no reported trauma in the area of the device. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8516598
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dennis100
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« Reply #7276 on: May 10, 2019, 11:49:32 PM »

Model Number 302-20
Device Problem Fracture
Event Date 03/14/2019
Event Type  Malfunction   
Event Description
Patient underwent full revision (replacement of the lead and generator) due to high impedance lead replacement and prophylactic generator replacement. The explanted lead and generator were received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8491529
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dennis100
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« Reply #7277 on: May 10, 2019, 11:51:27 PM »

Model Number 304-20
Device Problem High impedance
Event Type  Malfunction   
Event Description
Information was received that the patient had high lead impedance. The patient was later noted to be having an increase in seizures. The patient's lead impedance was noted to be ok following a lead replacement surgery. A review of the generator and lead manufacturing records showed that it passed all functional specifications prior to distribution. X-ray images were reviewed by the manufacturer. The connector pin could not be seen coming through the second connector block. The feedthru wires were intact. A strain relief loop was present, but not a strain relief bend. The lead wires at the connector pins also appeared to be intact at the connector pins. No sharp angles or gross discontinuities were visualized. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. It was noted by the physician that the surgeon had significant difficulty plugging in the wires and getting them out as plugged the wires into the old generator and confirmed high impedance. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8555084
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« Reply #7278 on: May 10, 2019, 11:52:29 PM »

Model Number 106
Device Problem High impedance
Event Date 03/19/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for surgery due to the surgeon¿s concern that the lead pin may have slipped out and the physician has reportedly obtained x-rays. Clinical notes were later received which reported that high impedance of >10,000 ohms was seen on the patient¿s vns and that the patient was experiencing an increase in seizures. The patient's generator was later replaced and lead impedance was within normal limits. The explanted generator was discarded. Information was later received that the surgeon had visually confirmed that the lead pin was not inserted past the second connector block both intra-operatively and upon review of the x-rays. The surgeon chose to replace the generator instead of re-inserting the pin into the generator. Additionally, there were no abnormalities were seen both visually (in the or) and on the x-rays. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8511132
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dennis100
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« Reply #7279 on: May 10, 2019, 11:53:15 PM »

Model Number 304-20
Device Problem High impedance
Event Date 03/23/2019
Event Type  Malfunction   
Event Description
The patient underwent full revision surgery due to battery depletion and high impedance. The sales representative present at surgery informed that the high lead impedance was discovered during an appointment with the patient's neurologist. The sales representative noted that they first switched out the generator to see if the high impedance resolved. The lead showed to have high impedance after the generator was replaced, so the lead was replaced as well. Further follow up with the neurologist confirmed that the reason for high lead impedance is unknown. The neurologist noted that in the operating room, the lead did not appear to be fractured. The sales representative received the explanted generator for return. The explanted product has not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8530162
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« Reply #7280 on: May 10, 2019, 11:53:53 PM »

Model Number 302-20
Device Problem Fracture
Event Date 03/01/2019
Event Type  Malfunction   
Event Description
An implant card was received which indicated that the patient had a full replacement due to high lead impedance. The explanted devices were not available for return and analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8527555
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« Reply #7281 on: May 11, 2019, 12:53:25 AM »

Model Number 303-30
Device Problem Fracture
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
Patient was referred for full revision (replacement of the lead and generator) due to low battery and high lead impedance. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8496049
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« Reply #7282 on: May 14, 2019, 12:36:17 AM »

Model Number 300-20
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2017
Event Type  Malfunction   
Event Description
Information was received indicating that the patient was experiencing an increase in seizures above pre-vns levels. Diagnostics were performed on the patient's generator and it was noted that the results were within normal limits. The patient has been referred for surgery. No known surgical interventions has occurred to date. No additional information has been received to date.
 
Event Description
Additional information was received from the patient's treating physician indicating that the patient had seizures due to intractable epilepsy and cerebral palsy and the recent increase in seizures were due to the vns generator battery depleting. The physician also believed the erratic stimulation was due to the low battery.
 
Manufacturer Narrative
The initial report inadvertently did not include (b)(4).
 
Event Description
The patient underwent a full replacement due to the increased seizures and reportedly due to a high impedance event occurring. The post-op impedance values after generator and lead replacement were within normal limits. No additional relevant information has been received to date.
 
Event Description
Additional information was received indicating that the high impedance was not identified by the patient's treating neurologist nor the patient's surgeon prior to surgery. Additionally, the most recent diagnostics from the patient's neurologist showed diagnostics within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6455257
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« Reply #7283 on: May 14, 2019, 12:37:08 AM »

Device Problems High impedance; Adverse Event Without Identified Device or Use Problem
Event Date 03/10/2017
Event Type  Injury   
Event Description
It was reported by the physician that the patient was uncomfortable with stimulation and he had requested how to perform diagnostic testing. It was later explained the patient was experiencing a shocking sensation with stimulation and the physician had decreased the pulse width and the frequency due to the shocking sensation. The patient was also sent for z-rays. One x-ray ap image, which included the neck and chest, was reviewed. The vns generator was in the left chest, the feedthru wires appeared intact, and the lead wires connector pin could not be fully assessed due to the image quality. A strain relief bend was present, but the presence of a strain relief loop could not be determined. While no sharp angles or gross lead fractures could be visualized due to image quality, there was a potential suspect location near the neck. An additional suspect area was noted above the generator and slightly above an additional lead for a device not associated with vns. However, it should be stated that it is unclear if the suspect areas actually show an issue with the lead, or if the suspect areas are just artifact. Additionally, proper electrode placement could not be determined due to image quality. The cause of the reported painful stimulation could not be conclusively determined. While there were no gross fractures or sharp angles conclusively observed in the image, a portion of the lead behind the generator could not be assessed; therefore, a lead fracture in that portion cannot be ruled out. The presence of a micro-fracture in the lead also cannot be ruled out.
 
Event Description
It was further explained by the physician that the patient¿s pain stopped when the device was programmed off; however, the patient experienced an increase in seizures due to the device disablement, so the device was programmed back on. The physician also mentioned high impedance was observed. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6459382
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« Reply #7284 on: May 18, 2019, 12:27:37 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Event Description
The explanted lead and generator were received by the manufacturer. It was not clear where or when the devices were explanted. Further follow-up with the physician's office found that the patient had passed away. However the facility would not provide any additional information about the patient's passing including date or cause of death. No additional relevant information has been received to date. The received generator and lead are currently pending product analysis.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the generator and lead. Upon interrogation, it was noted that the generator was at ifi = yes. The output of the generator was monitored for more than 24 hours and there were no variations observed with the output signal. The generator performed to functional specification. Upon review of the internal generator data during product analysis, it was revealed that high impedance was observed. The high impedance is reported in mfg report #1644487-2017-03688 as there is no indication that the high impedance is related to the patient¿s passing captured in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6453368
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« Reply #7285 on: May 23, 2019, 10:49:15 PM »

Model Number 304-20
Device Problem High impedance
Event Date 04/12/2017
Event Type  Malfunction   
Event Description
It was reported the patient had high impedance several times during surgery. The generator was isolated and tested with the test resistor pin and found to be working. The lead pin was re-inserted to verify adequate insertion and the lead was changed out. The patient's nerve was irrigated to make sure it had not dried and the size of the lead was checked to verify it was the appropriate size for the patient. It was later explained the surgery decided to close the patient and have the neurologist check the patient in a month to see if the high impedance was still present. The lead impedance reportedly showed >10,000 ohms during surgery. The device history records for both the lead and the generator were reviewed and each device had passed all testing prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: mfr. Report # 1644487-2017-03763 houses the report of the lead which was initially used but discarded during the surgery, prior to implanting the lead which is captured within this mfr. Report. " was inadvertently not reported on the initial mfr. Report.
 
Event Description
Mfr. Report # 1644487-2017-03763 houses the report of the lead which was initially used but discarded during the surgery, prior to implanting the lead which is captured within this mfr. Report. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6551021
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« Reply #7286 on: May 27, 2019, 10:41:51 PM »

Device Problem High impedance
Event Date 11/05/2015
Event Type  Malfunction   
Event Description
In a periodic review of programming history, it was identified that high lead impedance was registered on a vns generator. The device was interrogated and the settings observed were at shipping settings. Several system diagnostics were performed and results showed high lead impedance. The presence of generator interrogations on a dual pin generator immediately before this occurrence and interrogations and a single pin generator immediately after are suggestive this occurred in the context of a full vns replacement surgery, but this has not been confirmed to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6646688
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« Reply #7287 on: May 27, 2019, 10:42:23 PM »

Model Number 103
Device Problem High impedance
Event Date 05/30/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed during a follow-up visit. Further follow-up found that the x-rays showed there may be an issue with the lead and generator connection. Therefore the patient was referred for surgery where the surgeon intended to reinsert the lead pin in an attempt to resolve the high impedance. The x-rays have not been reviewed by the manufacturer to date. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent surgery where the lead was removed from the generator. The lead was then reinserted into the generator and diagnostic test results were within acceptable limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6664812
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dennis100
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« Reply #7288 on: May 27, 2019, 10:43:07 PM »

Model Number 300-20
Device Problem High impedance
Event Date 06/06/2017
Event Type  Malfunction   
Event Description
System diagnostic revealed high lead impedance. Surgery is planned for lead revision but no known surgical interventions have occurred to date.
 
Event Description
The patient underwent revision of generator and lead. The explanted devices were discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6665280
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dennis100
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« Reply #7289 on: May 30, 2019, 05:34:09 AM »

Model Number 302-20
Device Problem Fracture
Event Date 05/19/2017
Event Type  Malfunction   
Event Description
Report was received that stated a patient had visited his physician because of an increase in seizures. It was indicated this increase in seizures was not above pre-vns levels. While in the office, system diagnostics were run and high impedance was identified. Further information was received that indicated the patient's device was turned off because of the high impedance. No known surgical intervention has occurred to date. No further relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6638630
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