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Author Topic: Poor X-Ray Image  (Read 29995 times)
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dennis100
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« Reply #240 on: April 29, 2019, 05:10:35 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/25/2014
Event Type  Malfunction   
Event Description
It was reported the patient was undergoing a generator replacement due to battery depletion. At the surgery the generator could not be interrogated due to end of service. After the new generator was attached to the existing lead a diagnostic test was performed which resulted in high impedance. The surgeon attempted to reinsert the lead pin however the high impedance did not resolve. The lead was left implanted with the new generator. The explanting facility retained the explanted generator. Therefore product return is not expected. Further follow-up found that the physician first observed the high impedance two years prior. No further surgical interventions are known to have occurred to date.
 
Event Description
X-ray images were received for the patient. One of the images was prior to the high impedance and the second image was taken after the high impedance was observed. Due to the quality of the images the lead integrity could not be fully assessed and it was difficult to assess if the lead pin was fully inserted. No device issues were observed in the portions of the lead that could be evaluated.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6349143
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dennis100
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« Reply #241 on: May 03, 2019, 12:35:58 AM »

Model Number 300-20
Device Problem Fracture
Event Date 03/07/2017
Event Type  Malfunction   
Event Description
Information was received indicating that high impedance was observed on the patient's new generator during a replacement surgery. The surgeon verified proper pin insertion and orientation, but system diagnostics showed that high impedance persisted. The lead pins were removed and reinserted multiple times, which did not resolve the impedance issue. A test resistor was used and confirmed that the generator was function as expected. The surgeon was not comfortable completing a revision of the lead so the patient's new generator was programmed off. Impedance values prior to surgery were not available since the patient's previous generator was at end of service. A programming history database review was completed for the patient's previous generator to determine when high impedance was present. Based on the available information, no high impedance was detected as of (b)(6) 2009. To date, no known surgery to revise the lead has occurred. No additional relevant information has been received.
 
Event Description
The patient's family reported that the patient's mood had been affected by the loss of vns therapy from the high impedance. The patient's seizures were controlled. No surgical intervention has occurred to date.
 
Event Description
The patient's treating physician reported that the impedance was still high, so x-rays were performed. The x-rays were sent to the manufacturer for review. The lead pins were both inserted past the connector blocks. The generator appeared placed normally per labeling in the left chest, and the feedthru wires were intact. There appeared to be a gross fracture in one of the lead wires below the electrode bifurcation. However, the quality of the image was very low, so the presence of the fracture could not be confirmed. No lead revision has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6447298
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dennis100
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« Reply #242 on: May 07, 2019, 06:53:02 AM »

Model Number 300-20
Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's vns registered high lead impedance. The patient did not mention any trauma, and the chest x-ray as-reviewed by the treating physician did not reveal a clear lead fracture. The output current was set to zero, and the patient was referred to neurosurgery. Surgical intervention has not occurred to date. An ap chest x-ray image was reviewed by the manufacturer. The generator appears to have been placed normally per labeling. Both connector pins of the lead appear to be fully inserted inside the connector block. The feedthru wires both appear to be intact. No obvious fractures or sharp angles were noted. However, based on the quality of the image provided and only having one view, it was difficult to assess all portions of the lead for gross fractures or sharp angles. Both lead wires appear to be intact at the connector pins. A portion of the lead appears to be behind the generator and could not be assessed. The presence of a micro-fracture and/or a lead discontinuity with the portion of the lead behind the generator could not be ruled out. No additional pertinent information has been received to date.
 
Event Description
The patient¿s full vns replacement surgery was completed. The explanted lead and generator were received by the manufacturer and are undergoing product analysis. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process. This also includes an observation of burn-marks, consistent with electro-cautery at the time of device explant. No surface abnormalities were noted on this device. A pulse-disabled warning message and vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6390340
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dennis100
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« Reply #243 on: May 08, 2019, 10:04:02 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 02/08/2017
Event Type  Malfunction   
Event Description
It was reported that during an office visit, system diagnostics on the patient's generator resulted in a low impedance warning. No patient adverse events were reported. The physician planned on ordering x-rays to attempt to determine the cause of the low impedance. However, x-rays have not been reviewed by the manufacturer to date. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
X-rays were received and reviewed by the manufacturer. However, due to the quality of the images received, the lead was difficult to evaluate and the cause of the low impedance could not be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6373640
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dennis100
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« Reply #244 on: May 08, 2019, 10:04:36 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/25/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device had high impedance. X-rays were reviewed, and there appeared to be a fracture in the lead wire(s); however, the quality of the image was poor. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6530464
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dennis100
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« Reply #245 on: May 09, 2019, 06:57:22 AM »

Model Number 304-20
Device Problem High impedance
Event Date 03/21/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for a revision surgery due to high impedance observed on his vns. The device history records of the implanted generator and lead were reviewed by the manufacturer. It was found that all quality tests passed prior to distribution. The patient¿s lead replacement surgery was completed. Device diagnostics were performed preoperatively, and the high impedance was confirmed. The pocket was opened, and the lead was examined by the surgeon with no abnormalities identified. The neck was then dissected and the existing lead removed prior to the placement of a new lead. The explanted lead has not been received by the manufacturer to date. No additional pertinent information has been received to date.
 
Event Description
The explanted lead was received by the manufacturer, and product analysis is underway. Follow up with the office of the treating nurse practitioner showed that pre-operative x-rays were taken of the patient, but they were unable to visualize the vns lead sufficiently in the x-ray to find discontinuities. She believed the lead pin was fully inserted, but their assessment was limited by the image quality. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned lead portion. A small portion of the lead assembly including the electrodes was not returned for analysis. Therefore, a complete evaluation could not be performed on the entire lead product. The reported high impedance could not be confirmed on the returned portion. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at one point in time. Continuity checks of the returned lead portion were performed and no discontinuities were identified. There is no evidence to suggest discontinuities in the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6514210
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dennis100
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« Reply #246 on: May 11, 2019, 12:33:01 AM »

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 #247 on: May 14, 2019, 12:21:25 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance and limited output current delivered. It was stated that the physician could not see any lead breakage on the x-ray. The patient reported occasional pain around the generator site and an increase in seizures. From follow-up on the patient's seizures, it was stated that the patient's seizures were controlled, but suddenly began increasing again. The pain was reportedly random and infrequent. Lead revision surgery occurred, and it was stated that the surgeon had cut the lead and placed the new lead electrodes above the old electrodes which were left in place. Images of the explanted lead showed abraded openings and what appeared to be bodily fluid along multiple portions of the outer tubing. It was unclear based on the quality of the images if the inner tubing was compromised. It was reported that the explanted lead was not available to be returned to the manufacturer for analysis. No device was returned to date. No additional, relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8516917
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dennis100
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« Reply #248 on: May 18, 2019, 12:18:15 AM »

Model Number 302-30
Device Problems Fracture; High impedance
Event Date 05/04/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient¿s vns system. The treating physician did not turn off the vns at that time due to patient request. It was later reported that the patient¿s device was disabled prior to surgery because he could not swallow very well. The patient¿s surgeon performed a ct and x-ray of the system and reportedly could not identify a lead fracture. The patient¿s lead replacement surgery was completed. Within the surgery, a test resistor was used on the generator, which resulted in normal impedance in the diagnostic test results. The lead was replaced, and the high impedance resolved. The explanted lead has not been received by the manufacturer to date. No additional pertinent information has been received to date.
 
Event Description
The explanted lead was received by the manufacturer and is undergoing product analysis. The patient¿s operative reported was received and reviewed by the manufacturer. The vns system was verified to show high lead impedance before an incision was made. The generator was then disconnected, reconnected, and interrogated. The result again showed high impedance. Based on the operative report alone, it is not known if a diagnostic test was performed after the lead pin was reinserted. The generator was then removed, and a diagnostic with the test resistor was within normal limits. Visual inspection by the surgeon did not yield observations of fractures in the lead. Three x-ray images with an ap view of the neck and chest and lateral view of the neck were reviewed by the manufacturer. The generator was placed normally per labeling. The lead pin was visualized passed the connector block. The feedthru wires appeared to be intact. The lead electrodes appeared to be appropriately placed per labeling. No gross lead discontinuities were observed. A potential sharp angle was identified in the lateral neck view; however, it could not be verified to be part of the lead body or a likely sharp angle in comparisons with the ap view. The generator did not appear to obscure any section of the lead. Due to the quality of the images and overlaying body structures, the lead at the connector pin could not be fully assessed. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned lead portion. Note that a portion of the lead assembly was not returned for analysis. Therefore, a complete evaluation could not be performed on the entire lead. The condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at one point in time. Continuity checks of the returned lead portion were performed, and no discontinuities were identified. Based on the findings, there is no evidence of discontinuities in the returned portion of the device that contributed to the high impedance. Note that since a portion of the lead was not returned for analysis, an evaluation could not be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6599862
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