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dennis100
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« Reply #300 on: June 07, 2019, 04:59:07 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient was referred a generator site revision due to pain at the generator site. The patient had severe weight loss and it was recommended that the patient would replace their generator with a smaller generator. The generator was replaced. Per the physician¿s office, the patient¿s weight loss was due to bariatric surgery a year ago and unrelated to vns. The patient¿s pain was related to the migration, as the device would twist and move in the loose skin. The replacement was for both patient comfort and to preclude serious injury. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8591645
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dennis100
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« Reply #301 on: June 08, 2019, 05:03:12 AM »

Model Number 304-20
Device Problem High impedance
Event Date 03/25/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance and the device was disabled. It was noted that the physician reviewed x-rays and was unable to determine whether or not a clear wire break was present. It was noted that the patient reported no longer feeling stimulation resulting in the impedance being checked and found to be high. X-rays were received and reviewed for the patient. The connector pin can be seen coming through the second connector. The filter feedthru were confirmed to be intact. The lead wires appeared intact at the connector pins. No gross discontinuities were identified in the visible portion of the lead. A sharp angle was noted at the top of what appears to be the strain relief loop. It should be noted that the sharp angle may be a result of the angle of the image. The cause of the patient¿s high impedance could not be determined based on the images provided. 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 reported no trauma or manipulation to the area. It was noted that suddenly the stimulation was no longer perceived. No further physician¿s assessment of the high impedance was 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=8624293
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dennis100
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« Reply #302 on: June 08, 2019, 05:03:57 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/23/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance upon interrogation. The battery was noted to be at ifi (intensified follow-up indicator). X-rays were received and reviewed for the patient. 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 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. A strain relief bend, strain relief loop, and one tie-down were present. The lead wires appeared intact at the connector pins. No sharp gross discontinuities were identified in the visible portion of the lead. A sharp angle was observed in the main body 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 scale of the images and the limited images provided, the complete length of the lead from neck to generator could not be assessed as the image was not 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=8616027
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dennis100
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« Reply #303 on: June 09, 2019, 12:46:31 AM »

Model Number 304-20
Device Problem Fracture
Event Date 04/30/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was seen on a patient's device. It was also reported that all of the patient's output currents were programmed off. Additional information was received that per the neurosurgeon, it was assumed that it was in a dance class that she felt something had happened on the generator. Photos of the patient's ap and lateral neck and chest x-rays were also received and reviewed and revealed that the cause of the high impedance is likely lead fracture, as it does appear that the leads are coiled which can lead to a lead discontinuity as well as a possibly discontinuity visualized. Device history records were reviewed on and the device passed all functional specifications and quality tests and were sterilized prior to distribution. Though surgery is likely, 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=8633801
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dennis100
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« Reply #304 on: June 10, 2019, 12:29:14 AM »

Model Number 303-20
Device Problem Mechanical Problem
Event Date 09/15/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient has had a recent change in behavior, becoming very agitated and feels like she is being shocked. Follow-up from the company representative who spoke to the physician provided that he thought it was due to the last increase in dose. He also said that the patient is very thin and you can feel the lead which he then said it might have felt like it was twisted but not sure. He referred the patient to the surgeon for a check of the lead. All diagnostics checked out fine. Further follow-up from the provider indicated that they found a wire that appeared to be kinked. The device was functioning with no errors and impedance was within normal limits. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7019422
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dennis100
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« Reply #305 on: June 11, 2019, 12:34:00 AM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 09/22/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for vns generator replacement surgery due to an intensified follow-up indicator, or ifi, condition. During the replacement surgery, it was found that the lead was in a knotted state wrapped around the lead connector pin. It was also reported that the insulation was opened was compromised. Images of the lead condition were reviewed by the manufacturer. There appeared to be an opening in the lead insulation and fluid in the lead. The patient underwent a full vns replacement surgery as a result. Follow up with the company representative revealed that the patient was not a known twiddler and that there was no known trauma or patient manipulation that could have contributed to the condition of the lead. It was reported that the vns was still secured via suture when the patient underwent surgery. The explanted generator and lead have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6957201
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dennis100
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« Reply #306 on: June 12, 2019, 02:30:03 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 08/31/2017
Event Type  Malfunction   
Event Description
It was reported that the surgeon opened a lead package for a new patient implant and was concerned about the way the lead coils looked. The surgeon thought something was wrong with the lead coil and felt the lead coils were fractured in the package and thus did not use it. A different lead was successfully used for the surgery. A review of device history records for the lead shows that no unresolved non-conformances were found. Analysis is underway but has not been completed to date.
 
Event Description
The lead underwent product analysis and a kink in at least one of the lead coils was noted past the electrode bifurcation. The anchor tether was also visualized to be torn into two pieces and the suture partially detached from the helix. Suspected tool imprints were identified on the anchor tether silicone helix near the tear. Though difficult to state conclusively based on the inspection results it is believed that the most likely root cause for the anchor tether suture detachment and the observed damaged to the anchor tether helix was manipulation of the lead not consistent with our labeling. Other than the above mentioned observations and typical implant or explant related observations, no other anomalies were identified in the returned lead assembly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6922020
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dennis100
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« Reply #307 on: June 15, 2019, 11:10:01 PM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem; Under-Sensing ; Low impedance
Event Date 06/05/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the generator was not detecting heart rate. The internal data of the generator was reviewed and it was determined that low impedance had been detected on the device in the past as well as a large drop in impedance. Low impedance may interfere with heartbeat detection. The generator was later able to detect heart rate when the sensitivity was set to its least sensitive detection setting (sda sensitivity - 1). However, approximately four months later, the generator continued to have difficulty detecting heart rate. Low impedance was detected intermittently through system diagnostics. The patient reported that approximately a year ago she had felt a 'movement' in her neck, where the lead connected to the nerve and when she moved her head back, the movement reversed and 'went back. ' the patient said that she still felt normal and magnet mode stimulation. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's lead and generator had been replaced due to low impedance. During explant a kink in the lead was observed that had caused the tubing to rupture. Reportedly there was nothing unusual about the placement of the lead on the nerve. The explanted lead and generator were received, but product analysis on the devices have not been completed to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. The generator was able to sense heart-rate normally. No anomalies were identified with the generator. Product analysis was completed on the returned lead. The lead was received in two pieces and the electrodes were not received. Two (2) abraded openings in just outer tubing were identified. One abraded opening in the inner and outer tubing was observed. At this opening, a lead break in the positive coil was found and pitting conditions were observed at the location. Dried body fluids were identified in the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portion. No other anomalies were identified in the returned lead portions. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7011776
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dennis100
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« Reply #308 on: June 18, 2019, 12:27:54 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/06/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient experienced pain in the neck the chest and the left arm. The device was found to have high impedance. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. Pre-operative diagnostics did not show high lead impedance but imaging did show the nerve was being pulled on by the lead. Imaging showed the nerve was almost at a 90 degree angle due to lead pulling on nerve. The explanted devices were discarded in surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7134281
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dennis100
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« Reply #309 on: June 21, 2019, 12:24:40 AM »

Model Number 302-20
Device Problem Fracture
Event Date 11/09/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on the patient's device. It was also stated that the patient experiences pain during stimulation at times in the neck and chest. The patient was referred for consult with the surgeon however no surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received from the physician that the high impedance was observed upon interrogation of the vns device during a clinic visit. It was stated that the patient constantly touches the unit which could be a potential cause for the observed high impedance. The patient had a full revision surgery and the explanted lead and generator were returned for analysis however analysis has not been completed to date. On the date of replacement the impedance was noted to be ok however based on the position of the patient it could have shown to be ok so the device was replaced regardless.
 
Event Description
Product analysis was completed on the returned generator and lead. Generator analysis revealed there were performance or any other type of adverse conditions found with the pulse generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Lead analysis was completed. The lead was returned in one piece which did not include the electrodes. There were two set screw marks noted on the connector pin indicating that at one point in time proper contact existed between the set screw and the connector pin. The negative coil was kinked at one location and was also punctured at a separate location. Although, not conclusive, it appears this observed punctures are the result of the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Since the electrodes were not returned as well a full evaluation of the entire lead could be performed so a failure in that section of the lead could not be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7081841
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dennis100
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« Reply #310 on: June 21, 2019, 12:25:43 AM »

Model Number 300-20
Device Problems Mechanical Problem; Low impedance
Event Date 10/13/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that when the patient's generator was replaced, low impedance was observed with an impedance value of <600 ohms. It was reported that the impedance value was okay on the patient's previous generator. When the patient's generator was replaced, the existing lead was noted to be intertwined in a glob-like fashion. The lead was then un-clumped prior to being inserted into the new generator. The lead was retained, and not replaced at this time. The provider suspects the tubing over the existing lead was compromised and this is the cause for the low impedance. The patient was seen in the clinic one week after surgery as was able to perceive stimulation. No known surgical intervention has occurred for the lead. No other relevant information has been received to date.
 
Event Description
It was reported that this patient underwent a full revision surgery. The products will not be returned for product analysis. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7086291
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dennis100
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« Reply #311 on: June 23, 2019, 03:36:09 AM »

Model Number 302-20
Device Problems Fluid Leak; Appropriate Term/Code Not Available
Event Date 12/12/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a generator replacement surgery, the surgeon observed a break in the lead insulation and replaced the lead as well. The impedance was within normal limits prior to lead revision (2203ohms). It was reported that there was a kink / twist in the lead. The explanted lead has not been received to date.
 
Event Description
The generator and lead were returned. Abraded openings were noted on the outer silicone tubing. Abrasions were noted on the inner and outer silicone tubing at multiple locations. The outer silicone tubing has a compressed appearance at multiple locations. The lead assembly has dried remnants of what appear to have once been body fluids/betadine solution inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut end of the returned lead portion. 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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Pa on the generator: the pulse generator diagnostics were as expected for the programmed parameters. 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=7167451
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dennis100
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« Reply #312 on: June 25, 2019, 01:02:04 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem
Event Date 06/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the company representative was asked to attend a surgery she thought was only a generator replacement. However upon checking the device prior to surgery high impedance was observed. The lead and generator were then replaced. The explanted products have not been received to date. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were received and are pending analysis. The lead's product information was identified following the explant. It indicated that the lead had been implanted for several years. A review of the diagnostic history from the internal database showed that impedance was within acceptable limits in the most recent history.
 
Event Description
Analysis was completed on the returned lead and generator. The generator case had scratches, tool marks and burn marks which are consistent with manipulation and exposure to electrocautery during the explant procedure. Upon interrogation the battery indicator was found to be ifi = yes. A series of interrogations and diagnostics were performed on the generator and the results were normal. During testing the generator performed to functional specification and passed electrical testing. The lead assembly was received in two pieces with the lead¿s pin still connected to the generator. The furthest electrode to the bifurcation was not returned for evaluation. Prior to decontamination a continuity check was performed while the lead pin was still inserted into the lead and the continuity check verified there was proper contact between the set screw and the lead pin was present. Visual analysis of the lead completed for both lead segments. It was found that the lead was tangled and the outer tubing was abraded in the segment which included the lead pin. In both segments the lead coils were kinked and the electrode was noted to be damaged and partially detached, this was potentially related to the explant procedure. A fracture was identified in the lead coil in the lead assembly that was not attached to the lead pin and therefore not part of the continuity check. Pitting was observed at the point of fracture which indicates that the stimulation was being provided while the fracture was present.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7167569
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dennis100
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« Reply #313 on: June 27, 2019, 11:54:38 AM »

Model Number 304-20
Device Problem Fracture
Event Date 02/14/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Upon interrogation of patient's vns, the lead impedance was reported to be greater than 10,000 ohms. The patient reported no trauma to the vns area. The neurologist disabled the generator and referred patient for lead replacement. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent generator and lead replacement. Upon interrogating in the or the lead impedance remained above 10000 ohms. The surgeon opened the generator pocket and found that the lead was extremely coiled behind the generator. In an effort to extend the coil to access the lead body the lead severed in two. The surgeon removed as much of the old lead as possible and replaced the lead and the generator. The explanted devices were discarded. The lead was cut in several pieces to remove it.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7315463
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« Reply #314 on: July 05, 2019, 10:02:39 PM »

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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« Reply #315 on: July 14, 2019, 03:52:53 AM »

Model Number 303-20
Device Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 05/06/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
High lead impedance was observed on a patient's vns system during a follow-up visit. The physician elected to perform surgery to replace the patient's generator, as the battery was low, and planned to replace the lead upon evaluating its status at surgery. X-ray images were taken of the system prior to surgery, but the physician did not observe any lead discontinuities in the images. Upon explanting the generator during surgery, the physician observed that the lead was tangled and decided to replace the lead also. The physician observed a fracture in the lead after it was explanted. The physician reviewed the x-ray images again and observed that the fracture was actually visible in the images. The physician was unsure whether patient manipulation contributed to the lead fracture. X-ray images from several clinic visits were received by the manufacturer, but have not been reviewed to date. The explanted lead and generator have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7753753
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« Reply #316 on: July 26, 2019, 01:01:47 AM »

Model Number 304-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem; Low impedance
Event Date 12/08/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was seen on patient's device. It was noted that during a previous follow-up visit, the physician observed low lead impedance. No other relevant information has been received to date. There has been no known surgical intervention to date.
 
Event Description
X-rays were taken and provided for review. The x-rays indicated that 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 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. A gross discontinuity was identified in the visible portion of the lead near one of the tie downs in the patient¿s neck, and the second coil at the same location appeared to be bent at a sharp angle. The cause of the patient¿s impedance issue is likely due to the observed gross discontinuity. It was reported that the patient¿s lead and generator were explanted. The explanted products have not been received by the manufacturer to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8266360
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« Reply #317 on: August 09, 2019, 09:42:55 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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« Reply #318 on: September 06, 2019, 10:05:03 PM »

Model Number 302-20
Device Problem Fracture
Event Date 12/27/2018
Event Type  Malfunction   
Event Description
It was reported that high impedance was detected on the patient's generator. X-rays were reviewed by the manufacturer. Per the x-rays, although the angle of the image makes it impossible to visualize the pin past the second connector block, based on the ridges in the lead pin compared to the connector blocks, the lead pin is likely fully inserted. Strain relief was not per labeling. No apparent gross lead fractures were observed; however, there was a sharp angle in the lead below the electrodes. The cause of the patient¿s high impedance could not be determined based on the images provided. Note that the presence of a micro-fracture and/or a lead could not be ruled out. Data review confirmed that high impedance had been detected on the generator. No known relevant surgical intervention has occurred to date. No further relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8932651
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« Reply #319 on: October 11, 2019, 11:34:01 PM »

Model Number 302-30
Device Problems Fracture; Mechanical Problem
Event Date 08/12/2019
Event Type  Malfunction   
Event Description
Clinic notes were received for the patient indicating that the patient's device could not be interrogated due to battery depletion. Notes indicated that there was no discontinuities observed in the patient's lead on x-rays. The patient's generator was replaced due to the low battery. Upon replacement with the new generator, high impedance was observed. It was not seen on the previous generator as the previous generator could not be interrogated due to battery depletion the surgeon then found a kink in lead and sheathing gone. Due to lack of time, the surgeon could not replace the lead at that time. The explanted generator was discarded and the case ended without lead replacement. No further relevant information has 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=8971360
« Last Edit: October 11, 2019, 11:36:55 PM by dennis100 » Logged
dennis100
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« Reply #320 on: October 11, 2019, 11:38:24 PM »

Model Number 302-20
Device Problem Fracture
Event Date 06/01/2019
Event Type  Malfunction   
Event Description
It was reported by the sales rep that the patient reported increase chest pain and was referred to see the surgeon. X-rays were sent in for prompt review. The x-rays were reviewed and the generator placement was determined in the left chest. Based on the scope of the image, the feed through wires were intact and the pin could 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 bend could be visualized, however due to the scope and quality of the image it could not be determined is a strain relief loop was present. Two tie downs were present however based on the scope and quality of the image it could not be determined if they were placed per labeling. The lead did not appear to be routed behind the generator; however this could not be properly assessed due to the quality of the image. The lead wires at the connector pin appeared to be intact but the lead appear to be twisted sharply near rib 2. The lead was assessed for fractures and no gross fractures or discontinuities were noted. Based on the x-rays received, and the quality and scope of the images, the cause for the chest pain could not be determined at this time. Information was later received from the physician's office indicating that the patient's pain began around june around vns site but is not constant. The cause of the pain was indicated to be unknown. It was indicated that at that time there was no plan for intervention to be taken and the patient would continue to be monitored and follow-up with neurosurgery as needed if pain persists. An implant and warranty card was later received indicating the patient received a full revision due to a lead fracture. Per the surgeon, the patient complained of shocking sensations but there was no note of high lead impedance. The facility the revision took place does not return explants, therefore the explanted product is not available for product analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9128897
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dennis100
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« Reply #321 on: November 09, 2019, 12:14:37 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported via clinic notes received by the manufacturer that the patient's vns battery was dying and needed to be replaced. It was noted that the patient had complained of intermittent bleeding at the neck incision site. It was also stated that the patient had a nodule in his neck that the physician believed could possibly be a tangle of the vns lead wire. The impedance values were reported as within normal limits. The notes indicated that the patient was instructed to speak with the neurosurgeon regarding the nodule. No relevant surgery is known to have 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=9168852
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dennis100
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« Reply #322 on: November 09, 2019, 12:15:17 AM »

Model Number 302-20
Event Date 11/16/2011
Event Type  Malfunction   
Event Description
It was reported by a surgeon that high lead impedance was found after replacement of a patient's generator. The surgeon found that the lead was twisted near the generator site, and also that the patient had a damaged vagus nerve and a neuroma proximal of the lead next to the fixation area. The surgeon indicated that the patient was known to be a twiddler and it is suspected that the patient twisted the generator (as seen during surgery). The patient was described to be spastic and severely mentally disabled in accordance to the surgeon. X-rays were taken of the patient prior to surgery and no anomalies were noted on the review according to the treating neurologist.
 
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=2364121
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dennis100
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« Reply #323 on: November 09, 2019, 12:15:54 AM »

Model Number 300-20
Device Problem High impedance
Event Date 09/23/2019
Event Type  Malfunction   
Event Description
An implant card was received that indicated the patient's generator was replaced prophylactically. The lead impedance with the replacement generator was indicated as high, >=10,000 ohms. Diagnostics prior to the generator replacement are unknown to date. The or support specialist company representative indicated that the surgeon does not historically let representatives in the operating room. A surgical resident indicated that there was high impedance, prior to the surgeon entering the room. The representative suggested troubleshooting, but it is unknown to date if the troubleshooting was performed as the representative was not able to go into the room. At the end of the generator replacement case it was reported that there was still high impedance detected, the resident indicated that they inspected the lead and "noticed kinking and a small cut in the lead tubing. " no known relevant surgical intervention has occurred with the suspect product, the lead, to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9191162
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