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Author Topic: Tie Down/Anchor  (Read 27358 times)
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dennis100
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« Reply #210 on: April 08, 2019, 02:04:50 AM »

Model Number 302-20
Device Problems Mechanical Problem; Device Contamination with Body Fluid
Event Type  Malfunction   
Event Description
A patient's generator and lead were removed at the patient's request. This explant surgery and related reports of pain were captured in mfg report #1644487-2018-02291. Product analysis was completed on the returned lead product. The lead assembly was returned in one portion with one loose tie down; the electrodes were not returned. Setscrew marks were observed on the connector pin, providing evidence of proper mechanical and electrical contact between the generator and connector pin at one point in time. Abraded openings of both the outer and inner tubing were identified in the returned lead portion. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8389896
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dennis100
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« Reply #211 on: April 08, 2019, 02:05:40 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/14/2019
Event Type  Injury   
Event Description
It was reported that a patient was scheduled for a battery replacement surgery due to low battery. It was stated that during the surgery, the surgeon went into the neck incision site to "repair the lead" as it was noticed that the suture tie downs were extruding through the skin during interrogation of the original device. The pre-operative diagnostics were within normal limits. Post-op diagnostics were also within limits. It was stated that per the surgeon, the patient was a picker, though she could not confirm if this was the cause of the extrusion. The family had reported that the patient had been playing with the site as it was itching. Further information stated that the surgery was a revision of the suture near the lead instead of a generator replacement surgery. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8410642
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dennis100
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« Reply #212 on: April 11, 2019, 01:59:08 AM »

Model Number 304-20
Event Date 04/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had a lump under her jaw. She was experiencing pain and flushing with and without device stimulation. The physician evaluated the lump and assessed that it was related to the vns lead but was unsure how. The patient was referred to a surgeon for evaluation and after the evaluation she was referred for lead revision surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent exploratory surgery on her neck at the vns electrode site. During the surgery the surgeon removed an existing tie down because he believed it was too superficial and along with scar tissue it was causing the mass and pain in the patient's neck. The surgeon left a second tie in place since it was deeper and he did not believe it was contributing to the mass or pain. The vns lead and generator were left implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5780196
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dennis100
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« Reply #213 on: April 12, 2019, 12:34:21 AM »

Event Date 06/13/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a battery replacement due to the battery being at end of service. During pre-op, high impedance was observed during a diagnostic test. Surgery was postponed due to the patient eating prior to the surgery. X-rays were performed and reviewed by the manufacturer. The x-rays showed that the lead connector pin appeared to not be fully inserted. It was also noted that the lead was not placed per labeling. The strain relief bend was present but it was not secured by a tie down. There was not a sufficient strain relief loop and there were no tie downs present. Additionally, a portion of the lead near the electrodes could be not fully assessed. Therefore a potential lead fracture could not be ruled out in this portion of the lead. The surgery was rescheduled. During the surgery the lead pin was fully inserted into the generator and diagnostic testing was performed. The high impedance did not resolve after the pin re-insertion. The lead and generator were then replaced and the surgeon found a lead fracture near the anchor tether. The explanted lead and generator were disposed of following surgery. Therefore product analysis cannot be completed.
 
Event Description
It was reported that during the lead and generator replacement surgery the surgeon connected the existing lead with the new generator. The lead connector pin was fully inserted and the diagnostic tests were run which resulted in high impedance. The surgeon then proceeded to replace the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5779309
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dennis100
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« Reply #214 on: April 15, 2019, 12:18:58 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported the patient needed to be scheduled for a full vns revision due to high impedance. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient underwent full revision surgery on (b)(6) 2016. It was noted the patient had to be implanted on the right side as there was too much scar tissue and too many electrodes and anchor tethers on the left vagus nerve and there was no more room for an additional implant. It was noted the generator was replaced due to neos = yes (near end of service) and that the lead was replaced due to the high impedance observed. After the new generator and lead were replaced, the diagnostics were confirmed as ok. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received noting the devices were discarded after surgery. Therefore, the devices are not expected for return and no analysis will be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5857766
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dennis100
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« Reply #215 on: April 19, 2019, 01:11:08 AM »

Model Number 302-20
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that high lead impedance was observed on patient¿s vns system. Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution. X-ray was taken and sent to the manufacturer for review. It's unable to verify correct location of the generator due to x-rays partly available. The generator is located on the left side, close to the clavicle. The electrode pin is fully inserted and the feed through wires are intact. There is a suspicion of insulation break at 1 cm from the connector booth. No sharp angles are present no other abnormalities observed on the lead body. The electrodes seem to be aligned with the vagus nerve. No arguments for lead dislocation. Strain relief is present and placed according to the labeling. Two tie-downs are present, but not placed according labeling. Strain relief loop is not present. Based on the images, the cause of the high impedance could not be confirmed, but there is a suspicious area close to the generator. No patient adverse events were reported. No know surgical interventions were performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6131250
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dennis100
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« Reply #216 on: April 24, 2019, 01:38:43 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/17/2017
Event Type  Injury   
Event Description
It was reported that a vns patient had a retained suture, and was referred for surgery to revise the incision and remove the suture. The skin over the subcutaneous anchor was thinning and surgery was scheduled to prevent skin breakdown. Follow-up from the company representative who attended the surgery provided that a stitch through one of the tie downs was placed too shallow for such a small patient and had worked through the skin. There was no issue with the lead or any of the anchors. The stitch was removed and the tie-down cleaned up from some infection. Review of the manufacturing records confirmed the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Date of event, corrected data: the date of event was inadvertently provided incorrectly on the initial mdr.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6957232
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dennis100
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« Reply #217 on: May 03, 2019, 01:15:09 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/25/2011
Event Type  Injury   
Event Description
It was reported that the patient was referred for a vns removal surgery. The surgeon indicated that the patient¿s caregiver believed that the vns only made things worse for the patient. The exact adverse event was not specified at the time of the report. Follow up with the office of the surgeon showed that the patient had her vns generator and leads removed. The devices were reportedly discarded following explant. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Communication with the office of the treating neurologist showed that the patient was experiencing vns site discomfort. It was assessed to be due to the device presence and was likely occurring since device implant. One of the lead tie-downs appeared to be protruding, and it was assessed that it was due to the patient being small. The explant was believed to be just for comfort and was not to preclude a serious injury. Further information directly from the treating physician showed that the patient¿s lead was eroding through the skin, which was causing discomfort. He was not aware if the skin was broken at the lead site, as the patient¿s site was always either covered up with clothing or medical dressing. Communications with the office of the surgeon showed that all they knew regarding the patient¿s vns was that they were told the patient's mother thought the lead was affecting the patient¿s swallowing, likely from device stimulation. Notes on what was observed at the lead site were not taken, and it could not be recalled what was observed regarding the reported skin erosion. No additional pertinent information has been received to date.
 
Manufacturer Narrative
The suspect device was inadvertently provided as the generator, and the model#, serial#, lot#, expiration date were inadvertently incorrect as a result.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434719
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dennis100
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« Reply #218 on: May 20, 2019, 08:51:02 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that the patient had three breakthrough seizures, but the physician had also stopped the patient's vimpat. Diagnostics were performed, which confirmed that the device was functioning properly. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's tie-down was protruding at the neck incision. It was stated that the patient has not had efficacy possibly from the lead being placed too low also causing side effects. It was alleged that the patient started feeling a burning sensation and vibrating in the throat with auto-stimulation. It was thought that the increase in seizures could have caused the patient to have more autostimulations than usual, which caused the burning/vibrating in the neck area. The device was then disabled in may due to the burning sensation and vibrating in throat. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the device was likely disabled around (b)(6) as the patient was seen in the emu at this time. No additional or relevant information has been received to date.
 
Event Description
Information was received indicating that the patient is scheduled for a full replacement. Surgery is likely but has not been completed to date. No additional or relevant information has been received to date.
 
Event Description
The patient underwent a full explant. It was stated that x-rays were reviewed and revealed that the device was too low and the electrodes did not appear even on the nerve the explanted devices have not been received for analysis to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566145
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dennis100
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« Reply #219 on: May 27, 2019, 10:36:31 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/10/2017
Event Type  Injury   
Event Description
A patient reported that he had been experiencing pressure in the back of his head since his vns was initially implanted. The patient stated that the pressure was constant and did not occur with stimulation. The patient's device was programmed off for one week, but that did not relieve the pressure, nor did pain medication. The patient was later hospitalized for two weeks due to the pressure and a bout of non-epileptic seizures. The patient's treating neurologist reported that the patient had previously complained of this head pressure at his previous appointment prior to the report. The patient's vns output currents had been programmed down in response at that appointment. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The surgeon's office reported that the patient was referred for surgery to have the anchor tether of his lead removed due to it poking him. A company representative believed that the surgery had already occurred, but the surgical intervention has not been confirmed to date. No additional relevant information has been received to date.
 
Event Description
The anchor tether removal surgery was performed as intervention for the patient's pain and dysphagia. The surgery was for patient comfort and was not required to preclude a serious injury. Per the surgeon, the dysphagia improved some after surgery, and the pain fully resolved after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6649218
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dennis100
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« Reply #220 on: June 05, 2019, 12:04:25 AM »

Model Number 302-20
Device Problems Fluid Leak; Adverse Event Without Identified Device or Use Problem
Event Date 07/25/2017
Event Type  Malfunction   
Manufacturer Narrative
Device evaluated by mfr? na. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient was going for a vns explant due to the device being uncomfortable for patient and not working. Per a battery life calculation, the device would have reached eos prior to 2010. Therefore the device not working is likely due to battery depletion. The nurse mentioned that the patient had the surgery due to discomfort. Information regarding location of the discomfort and the onset of pain is unknown. The nurse mentioned that the surgery was done because patient requested it. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Further information was received that the lead was also explanted when the generator was explanted. No further relevant information has been received to date.
 
Manufacturer Narrative
The initial mdr indicated that device evaluation was not necessary as reported event(s) were not related to the functionality or delivery of therapy of the device. After the lead was returned and analyzed, a malfunction was found. This lead malfunction may have contributed the reported event as the cause of the reported event was not determined. Therefore, adverse event or product problem, corrected data: follow-up report #1 inadvertently did not include product problem suspect medical device, corrected data: follow-up report #1 inadvertently did not change the suspect device to the lead from the generator. Device code-event problem codes , corrected data: follow-up report #1 inadvertently did not include 1250, fluid leaks as a code. Type of reportable event, corrected data: follow-up report #1 inadvertently did not select 'malfunction' if follow-up what type?, corrected data: follow-up report #1 inadvertently did not select "device evaluation" device evaluated by mfr?, corrected data: follow-up report #1 inadvertently did not select "yes".
 
Event Description
Further information was received that product analysis was completed on the generator. Other than typical explant procedure related observations, no surface abnormalities were noted on the generator. An open can measurement of the battery voltage determined that the battery was depleted. The generator was unable to be interrogated due to this depleted battery condition. The generator performed according to functional specifications. Product analysis was also completed on the returned lead. A section of the lead assembly was returned for analysis in one piece, but the lead's electrodes were not returned for evaluation. Set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once. Abrasions were noted on the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing had a compressed appearance at multiple locations. The outer silicone tubing had what appeared to be internal abrasions at multiple locations. Abrasions most likely caused by the presence of a tie-down were noted. The inner silicone tubing of the lead coils is abraded open. The lead assembly had dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. No anomalies or discontinuities were found. An evaluation could not be made on the portion that was not returned. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820093
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« Reply #221 on: June 05, 2019, 12:05:08 AM »

Model Number 102R
Device Problems Detachment Of Device Component; Mechanical Problem
Event Date 09/01/2017
Event Type  Malfunction   
Event Description
Report received that while a generator was prophylactically replaced, it was found that the explanted generator header was bent. The header was reportedly bent prior to the explant procedure. The surgeon indicated he did not do anything during the surgery that bent the header and that it was bent while implanted. A review of the device history record showed the generator had passed all quality inspections prior to release for distribution. The generator has been received by the manufacturer and is pending analysis. No further information has been received to date.
 
Event Description
Product analysis was completed on the generator. A visual examination showed that the header was partially delaminated from the pulse generator case at two locations. Excessive tool marks were seen which were unexpected for a typical implant or explant procedure. An absence of dried bodily fluids or corrosion in the delaminated areas was also noted. The anchor was bent and the anchor pin was dislodged/trapped between the can and header. This caused the header to be bent to the side, opposite from the logo side. A visual examination also showed there was normal, complete header to can adhesive present in all areas. Scratches on the can were also seen and were typical marks found after explant. Discoloration was found likely from dried bodily fluids. Burn marks were also seen likely from an electro-cautery process. The generator communicated normally and all electrical tests were passed. No other anomalies were seen. No further relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6890683
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« Reply #222 on: June 08, 2019, 12:38:43 AM »

Model Number 1000
Device Problem High impedance
Event Date 04/25/2019
Event Type  Malfunction   
Event Description
It was reported that at the patient's initial titration session, high impedance of approximately 5,400 was observed on the patient's m1000 vns generator. The physician ordered x-rays to assess if a lead fracture or incomplete pin insertion was present. The physician did not want to program the patient's vns on until x-rays confirmed that there was no device malfunction. The x-rays were reviewed by the manufacturer. The m1000 generator was placed normally per labeling. Based on the angle of the image, it is unable to be assessed if the connector pin is fully inserted. The feed-through wires appear to be intact. A strain relief bend was present, but there was no indication of a strain relief loop and the tie-downs were not placed according to labeling. No apparent sharp angles or gross fractures were identified in the visible portions of the lead. However, a segment of the lead is behind the generator and could not be fully assessed. 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. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed. Additional investigation is underway. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8625693
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« Reply #223 on: June 09, 2019, 12:26:26 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8613562
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« Reply #224 on: June 15, 2019, 10:52:21 PM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem; Premature End-of-Life Indicator
Event Date 04/27/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that a generator battery depleted more quickly than anticipated. The generator was to be returned to the manufacturer for analysis. The generator has not been received to date and no other relevant information has been obtained.
 
Event Description
Further information was received from the nurse that the initial report of a generator not having the expected longevity was inaccurate. It was reported that the issue was actually a lead that did not function as expected. Further information indicated that high impedance was found on the patient's lead and first generator. This generator was replaced with a second generator on a later date, but the lead remained implanted. System diagnostics were run and high impedance was still reportedly present after this generator replacement. The second generator and lead were later replaced with a new vns system. The second generator and connected lead were returned to the manufacturer, but have not been received to date. The programming history on the first generator was not available at the time of the high impedance. There was no programming history available for the second generator. No further relevant information has been received to date.
 
Manufacturer Narrative
Corrected data, device manufacture date: supplemental mdr #1 inadvertently did not include the manufacture date for the lead.
 
Event Description
Further information was received that the patient's most recent generator and lead were received by the manufacturer. Analysis has not been completed to date. It was also reported that the explant date was initially reported incorrectly. The correct date was provided. No further relevant information has been obtained to date.
 
Manufacturer Narrative

Event Description
Further information was received that product analysis was completed on the generator. There were no visual anomalies observed. All diagnostic tests performed on the generator showed that lead impedance and current delivered was normal. The generator performed according to all functional and electrical specifications. The data from the generator provided measured impedance values throughout the time the generator was connected to the lead. This data showed that high impedance was present when the generator was first implanted but had resolved at a later date. After it had resolved, high impedance returned indicating the high impedance may have been intermittent. Product analysis was later completed on the lead. The lead was returned in three pieces, but portions of the lead were not returned and an evaluation could not be made on that part. Two sets of set screw marks were seen on the connector pin providing evidence that proper contact was made between the set screw and connector pin. Abrasions were noted on the silicone tubing of the lead coils past the electrode bifurcation. Abrasions were noticed along the outer silicone tubing at multiple locations. Abrasions caused by tie-downs were also noted. These abrasions were likely caused by normal wear and not the surgical procedure. A suspected coil break was identified in the positive coil past the anchor tether. A single broken strand was identified in the positive cold prior to the break location. Scanning electron microscopy images of the positive coil break and single broken strand show that pitting or electro-etching conditions have occurred at the break location. Due to mechanical distortion and/or metal dissolution, the fracture mechanism of the coil could not be determined. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead. No further relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6997669
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« Reply #225 on: June 19, 2019, 03:51:04 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 11/20/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient was getting a prophylactic replacement surgery. Diagnostics that were run before the operation and after the battery replacement indicated high impedance. The patient underwent a full revision surgery. The lead and generator were received and are currently pending analysis.
 
Manufacturer Narrative

Event Description
Product analysis was completed for the explanted lead and generator. Product analysis for the generator was reviewed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 658 volts as measured, showed the battery was not at an end-of-service condition. The data in memory locations revealed that 58. 740% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead was reviewed. The leads were returned in one piece, without the electrodes. A break was identified in the coil. Scanning electron microscopy images show that pitting or electro-etching conditions have occurred at the break location. Due to mechanical distortion (smoothed surfaces) and/or metal dissolution the fracture mechanism cannot be ascertained. Abrasions were noted on the outer silicone tubing at multiple locations, and were suspected to be caused by the presence of tie-downs used to secure the lead in the body. The silicone tubing was cut and the coils were kinked at various locations of the lead. These were likely caused during the explant procedure and likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The set screw marks seen on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7128571
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« Reply #226 on: June 22, 2019, 03:11:53 AM »

Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 12/18/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on the patient's device. The patient was referred for a full revision surgery because the generator was at 25% battery and the lead replacement is due to the high impedance. 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 that the patient's lead and generator were replaced due to the high impedance. The explanted generator and lead were planned to be sent back to the manufacturer so product return is expected. The lead and generator have not been received by the manufacturer to date.
 
Manufacturer Narrative
 
Event Description
The explanted lead and generator were returned for analysis. Analysis was completed on the lead. The lead was returned in one piece for analysis however the electrodes were not included. There were set screw marks on the connector pin indicating that at one point in time proper contact existed with the device. There were multiple locations of abrasions noted on the exterior of the lead. There were also internal abrasions noted most likely because of the presence of tie downs. A coil break was identified in the positive coil past the electrode bifurcation. A segment of the positive coil was subjected to sem inspection. The sem showed pitting at the lead break location however due to dissolution of the metal the fracture mechanism could not be obtained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
Generator analysis was completed on the explanted generator. There were no performance or any other type of adverse conditions found with the generator other than a low battery condition that was contributed to by the high impedance noted on the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7186479
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dennis100
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« Reply #227 on: June 25, 2019, 12:30:46 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/31/2014
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
A patient underwent generator explant surgery in 2014 due to a lack of efficacy with vns. It was later reported in 2017 via consult notes from a new surgeon that the patient had a lot of postoperative pain at the nuchal region, and the vns leads were twisting in his neck. The vns generator and a majority of the lead were explanted in 2015 due to the pain and movement of the lead. The new surgeon's consult notes also reported that the patient began to experience additional pain and tenderness related to the remainder of the vns lead present. Per the notes, the remainder of the lead was visibly protruding in the patient's neck and elevating and tenting the skin approximately 1. 5 inches above the neck incision site. The wound is reportedly well-healed. The pain associated with the protrusion caused the patient to become averse to touch at the neck. The physician believed that either the lead or tie-downs were causing the protrusion. The physician performed x-rays and identified 2 inches of remaining lead in the neck. The x-rays were not reviewed by the manufacturer. No additional relevant information has been received to date. No additional relevant surgical intervention has occurred to date.
 
Event Description
The original explanting surgeon confirmed that the patient had been experiencing pain that led to device explant. The surgeon reported that he did not observe a coiling of the lead. The surgeon also noted that the patient's initial explant surgery was for patient comfort and was not required to preclude a serious injury. The current surgeon believed that the cause of the protrusion may be related to too superficial an anchoring of the tie-down during initial implant. The surgeon also noted that removal of the patient's remaining lead was not required to preclude a serious injury and would be for the patient's comfort, as requested by the patient's mom who believed the tie-downs were becoming more superficial. No additional relevant information has been received to date. No known relevant surgical intervention has occurred to date.

Event Description
The patient underwent surgery to explant the remainder of the lead. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7176601
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dennis100
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« Reply #228 on: July 04, 2019, 12:44:21 AM »

Model Number 105
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 06/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that this patient was referred for replacement due to lead issues and generator migration. It was noted that the device moves in their chest, and every time it moves, the patient gets a shock that travels down his arm. Diagnostics were taken several times and were all within normal limits. Additional information was received from the patient's surgeon that a silk, non-resorbable suture was used to secure the generator to the chest wall during the patient's previous implant. It was then stated that it looked like the suture was no longer attached to the chest wall indicating that the generator was no longer secured. Additional information was received from the neurologist¿s office stating that the patient¿s mother had stated that the patient's shocking sensations had occurred a long time ago and he was no longer experiencing any issues. The lead underwent product analysis and two sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. No discontinuities were identified within the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The surgery facility is a no return site. No other relevant information has been received to date.
 
Manufacturer Narrative
Adverse event or product problem, corrected data: initial report inadvertently listed this field incorrectly. Outcomes attributed to adverse event, corrected data: initial report inadvertently did not list an outcomes. Brand name, corrected data: initial report inadvertently listed the incorrect suspect device. Type of device name, corrected data: initial report inadvertently listed the incorrect suspect device. Model#, serial#, lot#, expiration date, corrected data: initial report inadvertently listed the incorrect suspect device. Type of reportable event, corrected data: initial report inadvertently listed the incorrect type of reportable event. Manufacture date, corrected data: initial report inadvertently listed the incorrect manufacture date.
 
Event Description
Additional information was reported that the reason for the lead and generator replacement was due to shock-like pain during stimulation. The lead issues were specified to be related to the shock like symptoms during stimulation. As at the time of surgery, the lead tie downs were no longer secure in the neck and the generator was not sutured to the chest wall. The believed cause of the generator migration was stated to be due to the fact that the generator was not sutured to the chest wall, which was discovered at the time of replacement surgery. It was unclear as to the cause of the patient¿s painful stimulation, and why it was occurring down the patient¿s arm, but it was stated that the doctor assumes it was due to the pulling on the leads since they were no longer secure. It was stated that otherwise it could have been a lead malfunction such as a possible break in the wire. It was indicated that the patient¿s generator and lead replacement were both for patient comfort and to preclude a serious injury. The generator underwent product analysis and the device output signal was monitored in a simulated body temperature environment indicating no signs of variation. 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=7645903
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