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dennis100
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« Reply #150 on: September 19, 2018, 01:24:33 PM »

Model Number 303-20
Event Date 11/27/2013
Event Type  Malfunction   
Event Description
Analysis of the returned lead portions was performed. The lead assembly was returned in three portions with one tie down attached. Due to the condition of the lead as ¿ received, determining the connector pin versus the connector ring tri-filar coils could not be made during the visual analysis of the returned 202mm portion. The lead assembly has dried remnants of what appear to have once been body fluids inside the bilumen tubing, in some areas. An abraded opening was observed on the bilumen tubing approximately 8mm-10mm from the end of the cut bilumen tubing with one tri-filar coil exposed. White deposits were observed on the bilumen tubing. The end of the (+) white electrode tri-filar coil appeared to be melted. Incisions were made to allow for sem photos.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3539397
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« Reply #151 on: September 19, 2018, 01:25:10 PM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 04/16/2009
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Initial reporter indicated that their pt had high lead impedance. It was reported that in dec a box fell on the pt's neck and since that time the pt had not felt her vns stimulation and had hoarseness after talking on the phone for an hour that would resolve over time and was transient. The pt had full revision surgery and it was noted in the operating room that the pt's vagus nerve appeared swollen and was reported to have been injured by the pt's box injury in dec. No interventions were planned to treat the pt's vagus nerve injury. During surgery a gross lead break was noted prior to replacement of the vns system. Lead break was additionally noted on x-ray review prior to surgery. The pt's lead break was reported to have been related to their injury with the box falling on their neck in dec. It is unk the cause of the pt's inner silicone tubing abraided opening. The lead assembly was returned in two portions with one loose and one tie down attached. The green (-) electrode inner silicone tubing appeared to be abraded open approximately 6mm from the end of the electrode bifurcation and the quadfilar coil appeared to be broken in this area. During the visual analysis of the returned 331mm portion the green (-) electrode quadfilar coil appeared be broken in several areas. Visual analysis was performed and identified one of the areas as being thin which prevented identification of the coil fracture type with evidence of electro-etching on the surface. The add'l coil break was identified as having evidence of being melted with pitting on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.

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dennis100
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« Reply #152 on: September 19, 2018, 01:26:13 PM »

Model Number 302-20
Event Date 07/30/2012
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012, when the explanted generator was returned for product analysis but that the lead had been discarded by the hospital. It was later reported that the high impedance was first observed on (b)(6) 2012. Product analysis on the explanted generator was completed on (b)(6) 2012. The generator had been replaced for prophylactic reasons. The data in the memory locations revealed that 72. 275% of the battery had been consumed and the battery had a voltage left of 2. 837v. The results of bench diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Product analysis on the generator also showed that on (b)(6) 2012, the impedance value went from 11986 ohms to 20446 ohms, both of which are high impedance values.
 
Manufacturer Narrative
Date of event; corrected data: additional information was received which changes the event date that was reported on the initial report.
 
Event Description
Additional information was received on (b)(6) 2012, when it was reported that on (b)(6) 2012, the lead had been fully explanted, as it was reported that the patient had his vns explanted previously on (b)(6) 2012, it appears that only a portion of the lead had previously been explanted and the rest of the lead was explanted on (b)(6) 2012. The lead was reported to have been discarded by the hospital and therefore could not be returned for product analysis. The explanted lead however was returned for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information was received on (b)(4) 2012 when product analysis was completed on the explanted lead. A small portion of the (+) white electrode quadfilar coil was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 29mm portion the end of the (+) white electrode quadfilar coil appeared to be burnt. Scanning electron microscopy was performed and identified the burnt area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). What appeared to be spatter was found on the surface of the quadfilar coil strands. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. However, based on the observed mechanical and thermal damage to the coil ends, it cannot be determined whether the discontinuities are explant or product related. During the visual analysis of the returned 29mm portion the (-) green electrode quadfilar coil appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found at the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient had a full revision surgery on (b)(6) 2012, due to "spasms. " the surgeon later stated that the spasms were laryngospasms as well as choking. The patient's nurse practitioner later reported that the reason for surgery was in fact not "spasms" but a lead fracture. The patient did not have "spasms" prior to surgery. The generator was replaced for prophylactic reasons and the lead due to a lead fracture. The nurse stated that the lead was discarded after surgery and therefore, would not be sent back for product analysis but the generator would be sent back. The generator has not yet been received by the manufacturer for product analysis. The manufacturer's consultant stated that the high impedance was observed prior to surgery, upon interrogation during a clinical visit. There was no trauma or patient manipulation that occurred which could have caused or contributed to the high impedance. Attempts for further information have been made but have been unsuccessful.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include this information on supplemental report #1.

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dennis100
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« Reply #153 on: September 19, 2018, 01:28:05 PM »

Model Number 300-20
Event Date 08/28/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that during generator replacement surgery due to end of service, it was found that the lead pin was disconnected and the lead wire further down had exposed wire. The surgeon cut the lead and proceeded with a full revision. The reason for lead replacement was noted as lead discontinuity, with an exposed lead break. Product analysis of the explanted generator confirmed end of service as a result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications as defined in post burn-in electrical test. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. An analysis was performed on the returned lead portions which confirmed discontinuity. Note that the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 90 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 46 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. During the visual analysis of the returned 89 mm portion the end of the (-) unmarked connector quadfilar coil appeared to be broken approximately 49 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having the appearance of being melted. What appeared to be spatter was found on the surface of the quadfilar coil strands. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity on the (+) marked connector quadfilar coil and the melted area on the (-) unmarked quadfilar coil, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

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« Reply #154 on: September 19, 2018, 01:29:17 PM »

Model Number 302-20
Event Date 03/08/2012
Event Type  Malfunction   
Event Description
A vns patient had the vns generator and lead removed due to lack of efficacy (vns non-responder) and needing to have a port placed for chronic apheresis therapy per the treating neurologist. The explanted generator and lead were returned for analysis. No anomalies were noted with the generator and the generator performed per specifications. Analysis of the lead quadfilar coil 1 appeared to be broken in the body area of the lead assembly. Scanning electron microscopy was performed and identified the area on one of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The outer and inner silicone tubes appeared to be abraded open / melted and a coil strand from quadfilar coil 2 appeared to be broken in the body area of the lead assembly. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting, residual material and evidence of a secondary break line. The surface of quadfilar coil 2 was identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time) in this area. The outer and inner silicone tubes appeared to be abraded open / melted and an additional area on quadfilar coil 1 appeared to be broken in the body area of the lead assembly. Scanning electron microscopy was performed and identified the area on three of the quadfilar coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material. The fourth quadfilar coil strand and surrounding coil surface was identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. It is unknown exactly what caused the melted appearance on the outer and inner silicone tubes and melted appeared on the quadfilar coils. It is possible the silicone tubes and the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. The abraded open / melted areas found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. With the exception of the observed coil break and thermal damage/melting of metal, the condition of the remaining portions of the returned lead is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Electrode array was not returned. Follow up with the treating neurologist revealed no dysfunction was noted with the vns prior to explant, and the vns had been disabled since (b)(6) 2011. The patient had no trauma.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #155 on: September 19, 2018, 01:30:09 PM »

Model Number 201
Event Date 09/30/2009
Event Type  Malfunction   
Event Description
Initial reporter indicated to a manufacturing consultant that their programming wand is busted. It had melted where the 9v terminals are on the wand. The wand is at the manufacturer pending completion of product analysis.

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« Reply #156 on: September 19, 2018, 01:31:14 PM »

Model Number 302-20
Event Date 10/25/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury. The failure may have been related to the use of a cauterizing tool during explant.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during a generator replacement procedure for generator end of service, the lead wires were observed to be extruding through the outer insulation layer. The company representative indicated that there did not appear to be any damage to the coils or inner insulation; however the surgeon elected to do a full revision so that no further damage to the lead could occur. While performing the full revision, the surgeon identified a fracture in the lead. The impedance prior to the lead replacement was said to be within normal limits. The lead and generator were replaced, and diagnostics were performed with the new products and again found to be within normal limits. The explanted products have been returned to the manufacturer for analysis. Product analysis on the explanted generator has been completed however analysis on the lead has not. In the pa laboratory the generator was found to be at end of service. This was determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Product analysis on the lead was completed on (b)(6) 2011. Note that a portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer and inner silicone tubes of the returned lead. During the visual analysis of the returned lead, the connector ring and connector pin quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector ring quadfilar coil break of the returned quadfilar coil and identified the areas as being mechanically damaged with flat spots on the coil surface and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. Scanning electron microscopy was also performed on the connector pin quadfilar coil break and identified the areas on three of the coil strands as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). The fourth coil strand was identified as having evidence of a stress induce fracture (twisted appearance) with mechanical damage and no pitting. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool during the explant of this lead. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. With the exception of the abraded outer and inner tubing openings, and observed discontinuities the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

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« Reply #157 on: September 19, 2018, 01:32:23 PM »

Model Number 300-20
Event Date 11/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated a patient had vns lead and generator revision surgery due to an unspecified lead malfunction. Prior to the surgery, the patient was not feeling any vns stimulation. The patient had his vns generator replaced on (b)(6) 2011. After the replacement, the patient was not able to feel vns stimulation. The patient then had vns lead and generator replacement on (b)(6) 2011, due to a reported lead malfunction. Attempts for further information and return of the explanted devices are in progress.
 
Event Description
The explanted vns lead and generator were returned for analysis due to high lead impedance. No anomalies were identified with the generator and the generator performed per specifications. During the visual analysis of the returned 294 mm lead portion, what appeared to be a slice mark / abraded opening was observed on the outer and 1st inner silicone tubing approximately 39 mm from the end of the connector bifurcation. The 1st quadfilar coil appeared to be broken approximately 17 mm and 41 mm from the end of the connector bifurcation. Upon further analysis it was discovered that the outer silicone tubing, 1st inner silicone tubing and 1st quadfilar coil had a melted appearance. Scanning electron microscopy was performed on the 1st quadfilar coil and the areas were identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). What appeared to be spatter was found on the coil surface. It is unknown exactly what caused the outer silicone and 1st inner silicone tubing and 1st quadfilar coil to melt. Based on the obvious signs of melting on the coil surface, it is possible the thermally-damaged silicone tubes and quadfilar coil were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded openings and melted area found on the outer and 1st inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside. For the observed 2nd inner silicone tubing fluid remnants, there was no obvious path for fluid ingress other than the cut end that was made during the explanted process. With the exception of the observed melted areas on the outer and 1st inner silicone tubing and 1st quadfilar coil the condition of the returned lead portions is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Note that since a portion of the lead assembly (body) including the electrode section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Although a confirmed discontinuity in the body region of one of the returned quadfilar coils (polarity unknown) was noted, the break appears to be explant-related (cauterization tool). As the lead pin appeared to be fully inserted, a lead fracture is suspected in the lead portion not returned. Reporter indicated the patient was having increased seizures prior to the patient's previous generator replacement surgery, which occurred on (b)(6) 2011. The increased seizures were felt to be due to a depleting generator. The other generator was returned for analysis and was performing as intended and was not at end of service. It is likely the increased seizures and stimulation not perceived were due to the lead fracture preventing therapy, as no issues were noted with the previous generator. Per the reporter, the vns was noted to be "ok" in (b)(6) 2011, indicating proper device function at the time. The level of the seizure increase was not known, and the seizure type was not specified. The patient's seizures have returned to baseline levels since the (b)(6) 2011, vns lead and generator replacement surgery. X-rays were not done prior to the vns revision surgery. The patient had no trauma and did not manipulate the vns.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the product received date was inadvertently not reported. The product received date to the manufacturer is provided. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received to the manufacturer on (b)(6) 2012, confirming the patient had vns lead and generator replacement surgery performed on (b)(6) 2011. Diagnostics with the new lead and generator were "ok" per the implant card.

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« Reply #158 on: September 20, 2018, 10:17:16 AM »

Model Number 302-20
Event Date 02/27/2013
Event Type  Malfunction   
Event Description
The patient had their lead replaced on (b)(6) 2013 and their explanted product has been returned for analysis. Analysis completion is pending.
 
Event Description
Notes from the patient's (b)(6) 2013 surgery were received on (b)(4) 2013. The device was reportedly not functioning for several years. (this was clarified to mean the device was at end of service). In surgery, the generator was disconnected and a new unit was connected to the existing lead. Testing showed impedance: the device was rechecked and retested. Inspection of the lead showed a longitudinal linear separation in the plastic around the metallic wires. While the wires themselves were grossly intact and there was no side of disconnect or fracture, the sheath around the wires appeared to have been worn down and split in a linear distribution. The plastic itself appeared to have eroded away from the wires. The lead was not replaced at this time. The generator was sewn into place. Lead revision is still likely but has not taken place.
 
Event Description
The lead analysis was completed on (b)(4) 2013. Analysis of the lead showed that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis of the returned 309 mm portion showed abraded openings on the outer and inner silicone tubing in some areas. Visual analysis found that the quadfilar coil one appeared to be burnt in half in the body area of the returned lead portion. Scanning electron microscopy was performed and identified the burnt area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 211 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 250 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubing two and the torn ends observed on both of the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
On (b)(6) /2013, it was reported that high impedance was seen during generator revision due to end of service. The surgeon performed a generator diagnostic on the newly implanted generator. The generator was then reconnected to the lead ensuring that the pin was past the connector block and fully inserted. Diagnostics again showed high impedance. The surgeon inspected the portion of the lead that was able to be visualized, and a break was seen with fluid in the tubing. The lead was not replaced at this time. No patient manipulation or trauma was suspected, no x-rays were taken, and the explanted generator was discarded. The new generator was not programmed on. The last known diagnostics indicated a system diagnostic with dcdc=2 approximately two years prior. The patient was lost to follow-up; however, the patient had been experiencing an increase in seizures six months prior (below baseline), and the resident generator could not be interrogated or programmed because it was at end of service. The patient could not feel normal mode or magnet mode stimulation. The patient's physician believed the increase was due to loss of therapy. A blc at this time indicated negative results. Lead revision is likely but has not taken place.
 
Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional prior to distribution. Device failure is suspected but did not cause or contribute to a death or serious injury.

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« Reply #159 on: October 02, 2018, 12:39:06 AM »

Model Number 102
Event Date 07/03/2011
Event Type  Injury   
Event Description
It was initially reported that the patient was experiencing burning pain and swelling at their generator site. The pain is continuous and there was no reported trauma. The pain began one morning and continued to get worse until the generator was disable by the physician. The pain and swelling have resolved since device disablement. Diagnostic have not been perform since the device was disabled and there was concern that it would cause the patient pain. The patient was looking into possible vns replacement but that is not an option currently as medicare will not cover the surgery. Good faith attempts have been unsuccessful to date.

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« Reply #160 on: October 05, 2018, 12:23:32 PM »

Model Number 304-20
Event Date 08/09/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had low impedance results on his first follow-up visit following initial implant. Two system diagnostics were performed and showed low impedance. There was reportedly no trauma that had occurred since implant, but the patient reportedly felt a "heat sensation all day" at one point. The patient reported that they had still experienced coughing when the settings were increased. It was noted that impedance values were intermittently within normal limits pre-operatively. When the patient's position changed, he sometimes got impedance values in normal limits and other times got low impedance. The physician reported that he saw a "bubble" in the connector cavity that he believed was causing the low impedance. The surgeon opted to perform generator replacement and leave the lead intact. The explanted generator has not been received to date. No further relevant information has been received to date.
 
Event Description
After the patient's generator replacement surgery on (b)(6) 2016, the impedance values were within normal limits. It was reported that the explanted generator would not be returned for analysis per the explant facility's policy. X-rays were provided to the manufacturer for review. The a/p chest x-ray showed that the lead pin was fully inserted into the connector block, the feedthru wires appeared intact at the connector block, and the generator was placed normally in the left chest just below the clavicle. A portion of the lead was found routed behind the generator. No gross lead discontinuities were identified, no sharp angles were identified, and the lead appeared intact at the connector pin. An assessment could not be made on the portion of the lead routed behind the generator. Therefore, the presence of a microfracture and any additional information regarding the lead portion behind the generator cannot be assessed. No additional relevant information has been received to date.
 
Event Description
Full analysis was completed on the generator and confirmed its ability to accurately measure impedance values. The device was placed in a simulated body environment and the generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The generator was subjected to multiple electrical loads and verified the ability to accurately measure impedance values within an appropriate range. The generator septum was visually analyzed and verified that it was not cored. No other surface anomalies were identified on the generator. The generator performed according to all functional specifications with respect to accurately measuring impedance values.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator was returned and had product analysis completed, verifying that the generator was able to accurately measure impedance values. This verified that there was an intermittent short circuit in the lead. Negative impedance values were measured when there was a 0 ohm load applied to the generator.
 
Event Description
The explanted generator was returned for analysis. Historical diagnostic data was also provided and reviewed. Historical found the date that the low impedance message was first identified and verified that the impedance had bounced back up as previously reported to about 2,000 ohms at one time. The explanted generator is currently undergoing analysis.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not include information regarding post generator replacement. Relevant tests/laboratory data, including dates: the initial report inadvertently did not include the post generator replacement impedance value.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #1 inadvertently did not include notice that the generator had been returned.

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« Reply #161 on: November 09, 2018, 02:32:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Event Description
It was reported that the patient had redness and warming at the generator site and was prescribed antibiotics to treat the symptoms. In the doctor¿s opinion, after the first round of antibiotics the incision looks red but much better. The doctor is not overly concerned about the infection. The surgeon also stated that the incision looked fine. A review of device history records showed that the implanted generator was sterilized prior to distribution. All other quality tests also passed prior to distribution. No other relevant information has been received at this time.

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« Reply #162 on: November 10, 2018, 03:18:47 AM »

Model Number 300-20
Device Problem Fracture
Event Date 09/28/2018
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient's vns and that the patient experienced an associated change in feeling when the vns would stimulate over the few days prior to the observed high impedance. The vns output currents were programmed off and x-rays were ordered. It was stated that the patient greatly benefited from the vns and the physician hoped to minimize the time with her vns programmed off. It was later reported by the patient that her neurologist had informed her that there was something wrong with the leads, which needed to be programmed off, and that an x-ray was needed of the neck. The patient reported a burning in her throat prior to the disablement. The patient stated that surgery was likely and that she wanted to get this done as fast as possible as the vns had worked for her. The x-rays were reviewed by the manufacturer. The m106 generator was placed normally per labeling. The connector pins of the lead appeared to be fully inserted inside the connector block. The feed thru wires appear to be intact. The lead visibility varies throughout the length of the lead. Neither a strain relief bend, nor a strain relief loop appear to be present per labeling. A single tie down was present, but did not appear to be place 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 the visibility of the lead varies and these 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. The patient underwent full vns replacement surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted products and eventually discards the products. No additional relevant information has been received to date.

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« Reply #163 on: November 10, 2018, 03:19:28 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from the patient¿s mother that her daughter had some serious adverse events over the weekend. She mentioned that the patient started feeling dizzy and nauseous and she had pain and muscle spasms on the left side of her neck. The mother tried to tape the magnet over the patient¿s generator but she stated that it seemed like the vns shocked the patient. The mother then took the patient to the er and was able to successfully tape the magnet over the patient's generator to mitigate the symptoms that the patient was experiencing. She stated they then went to her neurologist but the mother was upset because the neurologist completely ruled out the vns device and did not address their concerns. She did say that the settings were changed and she was informed that the battery was low, so the mother felt that the issue could be occurring due to the low battery of the patient's generator. The mother was asked if there was any recent trauma and she stated that the patient had about 4 seizures from friday to sunday and the patient usually falls down due to her seizures and "runs into things all the time. " it was also reported that the patient also had extreme voice alteration. The mother also alleged that the ¿device misfired and patient is in pain, the device is shocking her. ¿ she stated that her daughter is having dizziness, her heart rate will be up in the 120 or in the low 40s. She stated that she was seen in the er on monday and they said to tape the magnet on it. She then stated that her daughter is weak and tachycardic. The er gave her a beta blocker. They have tried taping the magnet on it, but her chest is getting really hot. There were also changes in her voice. They had never had a problem with the vns before. The mother also alleged complaints of nausea and vomiting. The patient then stated she felt better when the vns was placed over the generator. The patient then said it was getting hot. So uncomfortable that she won¿t go to sleep. The father then said it was comfortable for 10-20 minutes and then goes vibrating and goes into legs and stomach. It also shocks all the way over to the left side of her chest. She stated that she felt bad enough to call the ambulance herself (herself being the patient). The patient was referred for replacement. Notes indicated the same allegations as previously mentioned including, that the patient reports electric shock sensation from the device to patient's neck and whole body, chest pain, magnet held in place over the device after going to the er, magnet made the device feel hot to the patient. Patient reports voice hoarseness of voice twitching on left side of the face, and headache all of which the family thinks is related to vns. The physician states recently she has been having more seizures. She is also having problems with the current device including feeling electric sharp like sensation in her chest and myoclonic movements in her neck and he is recommending a change in the vns device. The physician is recommending prophylactic vns device change so that the patient can have auto stimulation to help reduce her seizures specifically the electric shock-like sensation she is feeling and the cluster of seizures she is having. No surgery has occurred to date. No additional or relevant information has been received to date.

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« Reply #164 on: December 07, 2018, 10:20:53 AM »

Model Number 304-20
Device Problem Fracture
Event Date 10/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the epileptologist ordered x-rays for this patient because there was an issue with the leads. X-ray assessments were received and stated that the device has an unchanged appearance, and the reason for the exam was that the device was not working. Device leads were noted and were stated to be unchanged compared with appearance on chest x-ray from (b)(6) 2018. Clinic notes dated (b)(6) 2018 state that the patient is not feeling the device, but it burns in the left posterior neck when the patient swipes the magnet and no reported side effects. Diagnostics from this visit were indicated to be abnormal because the lead impedance is high. The doctor decreased the pulse width, and it was stated that this was much better tolerated. The physician stated that the cause of the burning paint the patient is experiencing is unknown. Clinic notes were also received from (b)(6) 2018 stating that the vns was interrogated and is functioning normally and diagnostics were stated to be ok at this time. Later in the clinic notes the physician states that they ¿will investigate lead disfunction in vns¿ and ordered x-rays at that time. X-rays were provided and reviewed by the manufacturer. Chest x-rays were not provided and therefore the generator was unable to be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. No sharp angles or gross discontinuities were identified in the visible portion of the lead. The cause of the patient¿s painful stimulation could not be determined based on the images provided. Note that incomplete pin insertion and 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. No known surgical intervention has occurred to date. No other relevant information has been received to date.

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« Reply #165 on: December 08, 2018, 02:08:01 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
Event Type  Injury   
Event Description
It was originally reported that the patient was experiencing pain at the incision site. Reported that the patient presented with what appeared to be an infection over the generator site. It was stated to be red and hot to the touch. The patient had a 102 degree fahrenheit fever. There were no other discomforts or pain associated with stimulation. Lab work was performed and confirmed that the patient had a bacterial infection. The patient was prescribed vancomycin and zosyn. A review of device history records was performed revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. It was later reported that the patient underwent vns explantation surgery due to the infection. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

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« Reply #166 on: December 08, 2018, 02:08:41 AM »

Model Number 106
Device Problem Insufficient Information
Event Date 10/15/2018
Event Type  Malfunction   
Event Description
It was reported that the patient is being referred for replacement due to low battery and because the patient is unhappy with the way in which the device is protruding. Clinic notes were received which stated that the patient had intense itching and burning at the site of vns implant. The patient also mentioned that they feel the vns device is not working. Multiple attempts were made to obtain information regarding the adverse events that were reported for the patient. However, no additional relevant information has been received. No known surgery has occurred to date.

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« Reply #167 on: December 30, 2018, 06:13:29 AM »

Model Number 302-20
Event Date 12/19/2013
Event Type  Malfunction   
Event Description
The patient underwent generator and lead replacement. The lead and generator were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Analysis of the generator was completed on 01/16/2015. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on 01/25/2015. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 408mm portion the (-) connector pin and the (+) connector ring quadfilar coils appeared to be broken approximately 325mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. Scanning electron microscopy was performed on the electrode (mating) end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type. Pitting was observed on three of the broken coil strands. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of the broken coils strands. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 325mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. During the visual analysis of the returned 408mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 334mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end and electrode (mating) end of the (+) connector ring quadfilar coil break (found at 334mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. What appeared to be melting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. What appeared to be residual material was observed in various locations. The abraded opening 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 observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
High lead impedance was observed during a follow-up appointment for the patient on (b)(6) 2013. The physician performed system diagnostics several times at different angles. Two of the diagnostics showed normal results; however, after this the rest of the diagnostics showed high lead impedance. The vns device was disabled (programmed off to 0ma). The physician plans to proceed with a "wait-and-see" approach. Ap and lateral chest and neck x-rays were sent to the manufacturer for review. Based on the images provided, the generator appears to be placed in a normal orientation in the left chest. It appears that the lead pin is fully inserted into the connector block. The filter feed-thru wires appear to be intact. The lead wires appear to be intact at the connector pin, and a portion of the lead wire appears to be located behind the generator so it could not be assessed. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be a strain relief bend present, but no strain relief loop appears to be present. There appears to be 3 tie-downs present. The first two tie-downs appear to be placed per labeling as they are placed parallel to the electrodes. The third tie-down does not appear to be placed per labeling given a lack of a strain relief loop. There does not appear to be any gross discontinuities or sharp angles in the lead. However, due to the image quality and the images provided, the entire lead body and generator could not be fully assessed. Follow up with the physician found that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance event. The patient has returned to his country where he will consult with another physician on replacement of the device. Surgery is likely, but has not occurred to date. No other information has been provided.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #168 on: January 09, 2019, 09:00:21 AM »

Model Number 104
Event Date 11/26/2013
Event Type  Injury   
Manufacturer Narrative
The initial report inadvertently did not report this information.
 
Event Description
Analysis of the returned lead portion will be captured in manufacturer report # 1644487-2014-00993.
 
Event Description
In addition to the redness and swelling in the neck, there was whiteness and fluid collection under the skin which the treating physician thought to be a potential ¿abscess¿ at the electrode site.
 
Event Description
It was reported that the patient presented with a possible hematoma. It was reported that the patient had presented with a potential infection at the generator site following generator replacement surgery. The physician reported that the patient suffered a fall and hit the generator site after generator replacement surgery. The patient was seen by the physician and the location was swollen and reddened. The site began to improve and then began to enlarge again and was warm to the touch so the surgeon started antibiotics. It was reported that the patient's mother indicated that the patient had been picking at the surgical site. The physician reported that the patient developed a new area of redness and swelling in her neck. There appeared to be about 2-3 cm of collection under the skin. The patient was referred to the emergency departement and was admitted to the hospital. It was later reported that the patient was explanted due to infection. A new system was not implanted at this time. The generator and lead were received for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

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« Reply #169 on: January 15, 2019, 03:10:08 AM »

Model Number MODEL 250
Event Date 04/18/2014
Event Type  Malfunction   
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the handheld was completed on (b)(4) 2014. During the analysis, it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing it from powering on. In addition to the main battery being swollen, it was also identified that the main battery would heat up while being charged and was unable to power the handheld long enough to perform interrogations and diagnostic tests. No further anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the surgeon¿s handheld device could not interrogate the patient¿s device during surgery on (b)(6) 2014. The wand battery was replaced, the cables were checked, and the handheld was fully charged. The surgeon also performed a hard reset due to an issue with the handheld screen and stated that the handheld device was malfunctioning.
 
Event Description
It was reported that the handheld was being returned for analysis. The handheld was received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #170 on: January 24, 2019, 04:10:27 AM »

Model Number 304-20
Event Date 07/29/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.
 
Event Description
The ent surgeon reported that during implant surgery the surgeon noticed that the negative and positive electrodes were stuck together. It was reported that it appeared as though the electrodeshad melted together. The surgeon was able to pull the electrodes apart and reported that there did not seem to be any visible damage to the lead. Device diagnostics once implanted were within normal limits. This event was previously investigated and concluded to likely be due to a manufacturing operator error and was missed during inspection. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr incorrectly stated that the event was previously investigated and concluded to likely be due to a manufacturing operator error and was missed during inspection. The cause for the event remains unknown, and the device is still implanted in the patient.

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« Reply #171 on: January 26, 2019, 03:16:42 AM »

Model Number 302-20
Event Date 07/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for generator and lead replacement due to either a lead break or sclerosis of nerve. It was reported that a lead break was not observed on x-rays. The patient underwent lead replacement due to high impedance and prophylactic generator replacement. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. During the visual analysis of the returned 360mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 13mm and the (+) connector ring quadfilar coil appeared to be burnt at approximately 25mm past the end of the abraded open / torn outer silicone tubing. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 13mm) and identified the area on three of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the fourth quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil burnt area (found at 25mm) and identified the area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). What appeared to be spatter was found on the surface of the quadfilar coil strands. Pitting was observed on the coil surface. During the visual analysis of the returned 45mm portion the quadfilar coil appeared to be burnt approximately 89mm past the end of the torn inner silicone tubing. Scanning electron microscopy was performed and identified the area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting was observed on the coil surface. During the visual analysis of the returned 23mm portion the (+) white electrode quadfilar coil appeared to have a spot-weld / slug attached to the end approximately 8mm from the end of the torn inner silicone tubing. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. The abraded open / torn areas found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. As expected, analysis of generator resulted in no anomalies.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute in a death or serious injury.

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« Reply #172 on: February 21, 2019, 01:51:08 PM »

Model Number 304-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient may have a broken lead as the patient¿s generator battery indication changed from 50% to 10% in 4 months. The generator was noted to be at ifi ¿ yes and the patient has been having a lot of seizures. Further follow up indicated that the patient¿ device diagnostics showed high impedance. Clinic notes were later received indicating that the patient had significant worsening in seizure duration and frequency. Patient is having complex partial seizures at the rate of 2-3 per day. Recent symptoms that patient experienced include: intermittent confusion, inability to talk, funny feeling in head, staring, and reporting that she was hot, staring spells, pausing at in appropriate parts of a sentence. Patient¿s compliance with treatment was reported to be good. Patient underwent full revision of the generator and lead on (b)(6) 2015. The explanted products were not returned to the manufacturer per the explant facility policy.
 
Manufacturer Narrative
Available programming and diagnostic history were reviewed. Device failure is suspected, but did not cause or contribute to a death.

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« Reply #173 on: March 25, 2019, 12:43:53 AM »

Model Number 302-20
Device Problems Housing; High impedance; Hole In Material; Migration or Expulsion of Device ; Material Twisted / Bent; Lead
Event Date 12/31/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that the patient was scheduled for a prophylactic generator replacement (b)(6) 2015 that turned into a full replacement. When the surgeon exposed the generator for removal, he noticed that the generator was spun around with the lead twisted and the lead housing was open with a single wire exposed. No high impedance was detected prior to the replacement as impedance was 4386 ohms. The generator and lead were replaced. Follow-up showed that according to the patient's parents, he does not have the dexterity with his hands to flip the device, but they could not come up with a better rationale except they said he does rock back and forth a lot and is sometimes restrained in his chair so he doesn't fall out and they believe he may have been pushing on the device when rocking back and forth. The surgeon did visual that a suture was in place to secure the generator which was no longer attached to the generator. The explanted devices have not been received for analysis to date.
 
Event Description
The explanted generator and lead were received for analysis on 02/02/2016. The reason stated on the return product form was prophylactic and visual lead discontinuity. Product analysis for the generator completed and approved on 02/23/2016. The vns programming history database shows no data available for this generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead was completed and approved on 02/25/2016. An analysis was performed on the returned lead portions and a 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 returned 337mm section was received in a twisted configuration, suggesting some level generator manipulation occurred while it was implanted. During the visual analysis of the returned 45mm portion the quadfilar coil appeared to be broken approximately 45mm from the end of the cut outer / inner silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting and mechanical damage which prevented identification of the coil fracture type. Two of the broken coil strands were found to have been mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type, with pitting on one. Another broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The area on the remaining broken coil strand was identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting and stress induced stress lines were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. During the visual analysis a portion of the lead assembly appeared to be twisted and compressed. Abraded openings were observed on the outer and inner silicone tubes, in this area. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.

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« Reply #174 on: April 06, 2019, 02:24:07 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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dennis100
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« Reply #175 on: April 07, 2019, 03:37:54 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2019
Event Type  Injury   
Event Description
It was reported from a nurse at the hospital that the patient was admitted due to the generator causing the patient pain especially when she lies down. The patient reported that this started occurring recently and got continually worse. The patient stated the device was not working but based this on the pain she was experiencing and no other adverse events or seizure activity. She reported a burning sensation around the generator site as well that occurred every 15 minutes or so. The nurse stated the pain wasn't associated with stimulation but she also couldn't be sure it was constant either. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8418353
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« Reply #176 on: April 16, 2019, 12:56:26 AM »

Model Number 302-20
Event Date 08/25/2016
Event Type  Malfunction   
Event Description
During a prophylactic generator replacement surgery, the surgeon saw the lead was tied in a knot. When he straightened the lead out, he noticed the insulation of the lead was degraded. Impedance on the previous device was less than 600ohms. Therefore the surgeon performed a full revision surgery. The explanted devices were received on 09/20/2016. Analysis is underway but has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported "mechanical problem / abraded insulation" (lead section) allegation was verified. The electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis the outer silicone tubing appeared to be compressed, twisted with abraded openings, in several areas. During the visual analysis, multiple lead portions appeared to be melted. What appeared to be spatter and pitting was found on the surface of the quadfilar coil strands. Based on the obvious signs of melting on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. The abraded openings and melted appearance 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the melted / torn ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 813 volts, shows an ifi=no condition. 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=5966266
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« Reply #177 on: April 22, 2019, 12:27:13 AM »

Model Number MODEL 250
Event Date 11/02/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the programming tablet was hot. The following day the tablet would not turn on. A company representative attempted to perform troubleshooting and confirmed that the tablet would not turn on. The company representative attempted to charge the tablet using multiple power outlets and multiple ac power adapter's however the tablet would still not charge. The physician did not require a replacement tablet since she had an additional tablet available. The suspect tablet was sent back to the manufacturer however it has not been received to date.
 
Event Description
The suspect tablet was received and is currently pending product analysis.
 
Event Description
Product analysis was completed on the tablet which was received with a depleted main battery. The tablet was powered using a known good ac power supply with no observed anomalies. The tablet booted to the vns welcome screen. The tablet was then successfully used to perform interrogations and diagnostic testing. The tablet was powered-on continuously for one hour and after the hour 73% of the battery remained. During analysis no temperature anomalies associated with the battery temperature were identified. The tablet performed to functional specifications. It was noted that the tablet was received without the ac power supply therefore analysis could not determine if it contributed to the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6130636
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dennis100
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« Reply #178 on: May 20, 2019, 09:48:56 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 #179 on: May 23, 2019, 11:26:06 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/02/2017
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
The patient was seen by his primary care physician due to concerns of a possible infection. The primary care physician noted that the patient had keloid formation, purulence, pain, warmth, and erythema all present in the chest area or at the generator incision site. The physician believed that the infection was caused by the patient's severe case of chest acne, which was incredibly active around the generator incision site. The combination of the bacteria from the acne and the incision site led to the possible infection, according to the physician. The patient was later referred to his implanting surgeon for follow-up. The patient was seen by his implanting surgeon. The patient reportedly had an abscess at his generator incision site, according to the surgeon. Cultures were taken and confirmed the presence of the infection. The patient was told to continue taking his antibiotic medication, which appeared to be related to his acne. The patient was seen one week later by the surgeon, and the infection at the incision site began to heal. No additional intervention was taken for the patient's infection. The device history records for the lead and generator confirmed that the devices met all sterilization specifications prior to distribution. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6672229
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