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Author Topic: Poor X-Ray Image  (Read 33833 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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dennis100
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« Reply #249 on: May 27, 2019, 10:30:52 PM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture; Appropriate Term/Code Not Available
Event Date 04/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a vns lead and generator replacement due to high impedance being observed. It was also noted that the patient was experiencing an increase in seizures. The physician reviewed x-rays of the patient and did not observe any obvious fractures however the patient¿s mother reported that the patient ¿messes with it all the time¿. X-rays were reviewed by the manufacturer and no obvious fractures were observed. Based on the ap view there appeared to potentially be a sharp angle in the region of the lead near the strain relief, however due to the quality of the image this could not be confirmed in the lateral view. Also due to the quality of the image provided the integrity of the lead near the lead pin could not be assessed. The connector pin did appear to be fully inserted into the generator and the generator¿s feed thru wires appeared intact. Based on the images provided no obvious source of the high impedance could be identified. It should be noted that the presence of a microfracture cannot be ruled out. It was later reported that the patient's family decided to disable the device before going forward with surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was further clarified that the increase in seizures began approximately a month prior to the high impedance warning being observed. At a later follow-up visit it was reported the patient continued to be experiencing an elevated seizure frequency and the patient's parents decided to change the patient's prescription medications rather than replacing the vns device.
 
Event Description
Patient plans to undergo full revision surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon took out the old generator but in the process he bent the header too much to where it broke the seal on one side. The new generator was connected to the lead and system diagnostics was performed again resulting in high impedance and >10,000 ohms. The lead was thus taken out. The surgeon noted that the lead wire was completely separated from the silicone cover in the middle portion. The surgeon was able to remove one of the electrodes but the other two helices were left on the nerve. The new lead electrodes were placed above the old electrodes. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. 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. The battery, 3. 011 volts , shows an ifi=no condition. The data in the generator memory locations revealed that 13. 112% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway and has not been completed to date. In addition, the header was partially detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was separated from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during the explant process. This will not be coded as it is due to explant process.
 
Event Description
Break was identified in the positive coil at two locations. Also, abraded openings were identified in the positive and the negative lead coils. Scanning electron microscopy of the positive coil show that pitting or electro etching conditions occurred at the 1st break location. Also, scanning electron microscopy images of the positive coil breaks (break-1 mate end, and break-2 ends) showed what appears to be wear (flat surfaces) on the coil strands, resulting in a reduction of the diameter of the quadfilar coil strands up to the break point. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6646622
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dennis100
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« Reply #250 on: June 07, 2019, 04:38:02 AM »

Device Problem High impedance
Event Date 04/23/2019
Event Type  Malfunction   
Event Description
X-rays were received by the representative with the report that there was higher/inconsistent lead impedance detected on the patient's generator. Per the x-ray images, the generator placement appeared to be in the upper left chest. The connector pin appeared to have been inserted completely per the images. The strain relief could not be assessed due to the quality of the images. One tie down appeared to be present; but based on the quality of the image provided it was unable to assess whether the tie down was the sole tie down and whether it was placed per labeling. Due to the quality and angle of the image an assessment could not be made regarding whether the lead was behind the generator or if the leads were intact at the connector pin. No gross lead fracture or sharp angles were observed in the visible portion of the lead; however, the entire lead body could not be accurately assessed. Based on the images provided, no obvious source of the high impedance was observed; however, the presence of micro-fractures cannot be ruled out. 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=8613484
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dennis100
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« Reply #251 on: June 08, 2019, 12:30:38 AM »

Model Number 302-20
Device Problem Fracture
Event Date 05/02/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was interrogated and found to have a high impedance reading. An ap neck and chest x-ray image was received and reviewed by the manufacturer. Based on the images provided, the feedthru wires appeared intact at the connector pins. Due to the angle of the generator, full lead pin insertion could not be confirmed, as the lead pin could not be clearly seen coming through the second connector block. The device was placed in the patient¿s left chest per labeling. The lead was observed in the neck and chest. Note that portions of lead, especially around the generator, were not visible due to poor image quality and therefore could not be assessed. Additionally, a portion of the lead was routed behind the generator. A strain relief bend was present per labeling; however, no strain relief loop was present. 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. 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=8635763
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« Reply #252 on: June 08, 2019, 12:31:26 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/18/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance. X-rays were performed, received, and reviewed. The generator was located in the patient¿s upper left chest. The connector pin can be seen coming through the second connector block. The filter feedthru wires were confirmed to be intact. The lead was observed in the patient¿s chest and appeared to be routed toward the patient¿s left chest. The strain relief loop and bend and presence of tie-downs was unable to be assessed due to poor image quality and the angle of the image. There was a portion of the lead that was routed behind the generator, and the lead wire is unable to be assessed to be intact at the connector pin due to poor image quality. In the visible portions of the lead, a sharp angle was noted on the main lead body near the electrodes. Patient implant history indicates that the patient previously underwent lead replacement. Due to the image quality and angle of the image it is unclear if the sharp angle observed is remnant of the previous lead and electrodes or a sharp angle in the currently implanted lead. No gross discontinuities were identified in the visible portion of the lead. The cause of the patient¿s high impedance is not able to be assessed based off of the x-ray shown. 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. Further information was received that the patient underwent exploratory surgery. Pin re-insertion was attempted and high impedance was still observed. A test resistor was then used with the generator and impedance was ok. The generator was re-connected to the lead and high impedance was observed again. No further surgical action (device revision) was performed. No other 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=8605626
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dennis100
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« Reply #253 on: June 09, 2019, 12:24:34 AM »

Model Number 1000
Device Problem High impedance
Event Date 04/22/2019
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
Patient presented with high impedance. X-rays were performed. X-rays were received and reviewed. The generator was located in the patient¿s upper left chest. The connector pin was unable to be assessed coming through the second connector block due to the angle of the image. The filter feedthru were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. It should be noted that all of the lead electrodes or the top portion of the lead are not present in the range of the image. A strain relief bend is present, but the strain relief loop and the present of the tie-downs in the out of range portion of the patient were unable to be assessed due to the limited range of the neck area in the image. Tie-downs are not present per labeling as there is not a tie-down on the strain relief bend. A portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins. No sharp angles or gross discontinuities were identified in the visible portion of the lead. Based on the x-rays received, the cause for the high impedance could not be determined. The presence of a fracture or micro-fracture in the lead cannot be ruled out. It should be noted that due to the range of the ap chest image, the complete length of the lead from neck to generator could not be assessed as the image was not provided. It should also be noted that a lateral chest x-ray was provided and due to the image quality contrast, the vns lead or generator were unable to be observed or assessed. No clinical symptoms were reported for the patient. 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.

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« Reply #254 on: June 11, 2019, 12:15:29 AM »

Model Number 302-20
Device Problem Fracture
Event Date 09/22/2017
Event Type  Malfunction   
Event Description
It was reported on that the patient has high lead impedance was observed. The device was programmed off. Two anterior/posterior chest and neck x-rays and two lateral chest images were provided for review. Based on the quality and angle of the images, the lead pin could not be assessed for complete insertion past the connector block. The generator appeared placed normally per labeling in the left chest, and the feedthru wires were intact. The electrode placement was done as per labeling. Strain relief bend appears to be present per labeling and a strain relief loop is present. Based on the images received, tie-downs securing the strain relief appear to be missing. A small portion of the lead was behind the generator, and the lead was intact at the connector pin. There did not appear to be any sharp angles or gross fractures in the available images. The cause of the high impedance could not be determined based on the images provided. Surgical intervention has not occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6958095
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« Reply #255 on: July 05, 2019, 09:39:00 PM »

Model Number 304-20
Device Problem High impedance
Event Date 04/21/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient had a prophylactic generator replacement and leads replaced due to high impedance. The representative reported that pin re-insertion was attempted during the revision surgery but did not resolve the high impedance. It was reported that a test resistor with the generator provided impedance within normal limits. It was reported that the patient was punched in the chest, and the physician believed the trauma to be the cause of the high impedance. X-rays were received and reviewed by the manufacturer. Based on the images received, the generator appeared to be placed lower in the chest than suggested in labeling. Labeling suggests the generator be placed at or above rib 4, and the generator appeared to be located below rib 5. This generator placement caused the lead to appear taut. Due to the quality and angle of the image, it was unable to determine whether the lead pin was fully inserted inside the connector block, whether the lead was routed behind the generator, and whether the lead wires were intact at the connector pin. The strain relief of the lead was not placed per labeling. There were no apparent gross lead fractures, sharp angles or other anomalies in the visible lead portions. The cause of the patient's high impedance could not be determined based on the x-ray images provided. Note the presence of a micro-fracture and/or lead discontinuity in the portions of the lead not visible could not be ruled out. It was reported that the explanted products were not available for return by the manufacturer; therefore, return of the suspect product is not expected to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8708483
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« Reply #256 on: July 05, 2019, 09:39:41 PM »

Model Number 304-20
Device Problem Fracture
Event Date 06/05/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was detected on the patient's generator. It was reported that the patient was not experiencing any adverse events related to the high impedance. The patient was referred for lead revision due to high impedance and prophylactic generator replacement. The physician reviewed patient's chest and neck x-rays and indicated there were no visible fractures present. X-rays were reviewed and the generator appeared to be placed in the upper left chest per labeling, feed thru wires were intact and the connector pin appeared to be fully inserted. It was unable to assess whether the lead wires were intact at the connector pin due to the quality of the image and contrast of the lead portion that was near the generator. Strain relief appeared to be placed per labeling with three tie downs visually present and in the visible portions of the lead there were no fractures or sharp angles observed. The presence of micro-fractures could not be ruled out; however, based on the images provided, there was no obvious cause for the reported high impedance identified. No known relevant surgical intervention has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8744075
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« Reply #257 on: July 11, 2019, 12:20:07 AM »

Model Number 304-20
Device Problem Fracture
Event Date 05/24/2019
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during follow-up it was found that the patient had high impedance with a low output current. The physician was recommended to turn the device off and refer the patient for x-rays. Anterior posterior electrode close up x-rays were received and reviewed. The generator placement was determined to be normal in the left chest. Based on the scope of the image, the feed through wires were intact, however the pin could not be visualized passed the second connector pin per the scope and angle of the image. The lead was visualized in the chest and neck. The strain relief loop and the strain relief bend did not appear to be present per labeling. Tie downs could not be visualized per the quality of the image. Based on the scope and quality of the image, it appears the lead is routed behind the generator. It could not be assessed if the lead wires were intact at the connector pin per the quality of the image. The lead was assessed for fractures and no gross fractures or discontinuities were noted, however a portion of the lead appeared to be tangled near the connector pin. Based on the x-rays received, the cause for the high impedance cannot be determined at this time, however based on the evidence of the lead being tangled the cause is possibly from manipulation of the lead. The presence of a fracture or micro-fracture in the lead cannot be ruled out. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8705255
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dennis100
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« Reply #258 on: August 09, 2019, 09:35:27 PM »

Model Number 302-20
Device Problem Fracture
Event Date 07/09/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance. The patient was referred for x-rays and full revision (replacement of the lead and generator). Neck lateral and chest ap x-rays were received for the patient. The generator was located in the patient¿s upper left chest. The connector pin cannot be seen coming through the second connector block due to the angle of the image. The filter feed thru were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There was a portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins. No sharp angles were identified in the visible portion of the lead. In the visible portions of the lead, no discontinuities were observed. A portion of the lead near the generator was unable to be assessed for discontinuity due to the angle and contrast of the image. The cause of the patient¿s high impedance could not be determined based on the images provided. 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=8841121
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dennis100
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« Reply #259 on: August 09, 2019, 09:36:05 PM »

Model Number 304-20
Device Problem Low impedance
Event Date 06/27/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device has low impedance and that there are no complaints from the patient. Anteroposterior and lateral chest x-rays were received and reviewed. Per the images received, the connector pin insertion cannot be assessed due to the quality and angle of the image. The placement of the generator is normal. The feed thru wires do not seem intact at the connector pin and appeared bent. The lead was located behind the generator and the lead wires at the connector pins could not be assessed due to the quality and angle of the image. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There is no strain relief loop or bend present. One tie-down was visualized and not placed per labeling - tie down and lead were not located parallel to the electrodes. No gross fractures were visualized however a sharp angle was seen, directly below the electrodes, and appears to be looped over itself. Based on the x-rays received, the cause of the low impedance cannot be determined, as no obvious short circuit condition could be visualized. The sharp angle below the electrode and the bent feed through wires cannot be ruled out as possible causes, however, cannot be confirmed to be reasons for the low impedance. A possible fracture or short circuit in the part of the lead that was not able to be visualized in the x-ray images and also cannot be ruled out. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8798633
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