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dennis100
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« Reply #120 on: March 31, 2019, 06:35:55 AM »

Model Number 302-20
Event Date 04/08/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system. The patient was due to undergo generator replacement surgery, when high impedance was identified; the vns patient's device was tested and system mode diagnostic results revealed high impedance (dc dc code 7) and near end of service = no. It was reported that the device replacement surgery was performed. The patient's vns system was tested upon connection of the new generator to the existing lead and high impedance persisted. It was reported that the newly implanted device was disabled. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Additional information was received indicating that the generator was replaced due to battery depletion. The return of that explanted device to the manufacturer is expected but it has not been received to date. It was reported that a lead revision due to lead discontinuity is planned. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator was received to the manufacturer on 04/28/2016. Analysis of the returned generator was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
Further information was received indicating that the patient underwent lead replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity. The patient's vns system was tested upon connection of the new lead to the generator and system diagnostics returned impedance results within normal limits with 1568 ohms. The explanted lead was returned to the manufacturer on 06/09/2016. Analysis is underway but it has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of "fracture of leads" were confirmed. Note that the (-) green electrode 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 40mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 19mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. During the visual analysis of the returned 9mm portion the end of the (+) white electrode quadfilar coil appeared to be broken approximately 18mm past the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture with pitting. Flat spots and pitting 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. 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 white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the tissue-covered (+) white electrode ribbon 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. However, the positive electrode condition may have contributed to the reported ¿high impedance¿.

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dennis100
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« Reply #121 on: April 05, 2019, 01:17:55 AM »

Model Number 302-20
Event Date 07/30/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On 5/16/2016 the patient¿s mother reported that her daughter¿s generator was unable to be interrogated by the new physician and that her previous physician noted an ¿impedance issue¿ at the last appointment on (b)(6) 2015. The mother noted that it was very difficult to get her daughter's device managed because she was never able to consistently see a physician or at the same facility. The patient¿s mother then stated that over the last several months ((b)(6) 2015), her daughter has been having an increase in grand mal seizures and the mother was concerned that it would get worse. The mother confirmed that the patient is not as bad as she used to be prior to the vns therapy. The patient¿s mother later reported that high impedance had been seen during the clinic visit on (b)(6) 2015. At that time, no therapy level adjustment was made to discontinue therapy. The doctors had told the patient the high impedance was possibly due to scar tissue but therapy was allowed to continue. The patient¿s new doctor is unable to communicate with the patient's vns therapy system and the patient reports an increase in seizures as well as a failure of the magnet to abort the seizures. The patient¿s settings were noted to be output=2ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=1. 1min. A review of the patient¿s programming history revealed that system diagnostics performed on (b)(6) 2015 showed results within normal limits and no high impedance.
 
Event Description
Generator and lead replacement surgery occurred on (b)(6) 2016. The explanted devices have not been received by the manufacturer to-date.
 
Manufacturer Narrative
Relevant test data, corrected data: the date of systems diagnostics was inadvertently reported as (b)(6) 2015, when the date was intended to be reported as (b)(6) 2013.
 
Event Description
Additional information was received that the patient was referred for revision surgery. It was reported that the device had been turned off for a while. The generator and lead were explanted on (b)(6) 2016. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
The explanted lead and generator were received. Analysis was completed for the returned lead portions. The lead coil appeared to be broken approximately 1mm and 2mm from the end of the electrode bifurcation. A short section of coil was observed between the two coil breaks. Scanning electron microscopy was performed on the coil break found at 1mm and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting and flat spots were observed on the coil surface. Scanning electron microscopy was performed on the short section of the coil break found between 1mm and 2mm and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the coil break found at 2mm and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting and flat spots were observed on the coil surface. Abraded openings were found on the outer silicone tubing, and most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed on the connector boot. During the visual analysis electrode ribbons appeared to be partially embedded in what appeared to be remnants of dried body tissue. With the exception of the observed discontinuities, abraded openings and tissue covered electrode ribbons the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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. No other anomalies were noted. Analysis was completed for the returned generator. Review of the downloaded data from the pulse generator shows high impedance on the date of explant, (b)(6) 2016. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The pulse generator was interrogated at multiple orientations adjacent to the programming wand. The pulse generator interrogated at all orientations. The device output signal was monitored while the pulse generator was placed in a simulated body temperature environment. Results showed that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring, demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, voltage measured 2. 938 volts and shows the intensified follow-up indicator was not set. The downloaded data revealed that 26. 496% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #122 on: April 10, 2019, 12:47:50 AM »

Model Number 103
Event Date 06/14/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed an post-operative infection at the surgical site following a recent generator replacement surgery on (b)(6) 2016. A surgery was planned initially for the device removal. The surgeon later elected to hold off on the explant surgery that was scheduled as the patient's blood work was much better and so was the would at incision site. Additional relevant information has not been received to date. A review of device history records showed that the generator was sterilized prior to distribution.
 
Event Description
Additional information was received on (b)(6) 2016 that the patient still has infection. Patient underwent explant of the vns generator and lead on (b)(6) 2016 due to infection. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received for analysis on 09/29/2016. Verification of the alleged ¿infection¿ is beyond the scope of activities performed in the pa laboratory environment. However, potential contributing factors to this condition have been considered / evaluated and none were found to exist in this situation. The dhr shows that the pulse generator passed all specifications prior to its release. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 973 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions for the reported allegation of; ¿explanted / due to infection¿ (lead and patient sections). The allegation is not an actionable issue. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near 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 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. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint.

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« Reply #123 on: April 11, 2019, 01:39:46 AM »

Model Number 302-20
Event Date 06/14/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported the patient was found to have high lead impedance on (b)(6) 2016. The patient denied any trauma which may have caused the device failure. Chest x-rays were ordered and a battery life calculation was performed to see if the patient would need a full vns revision. A battery life calculation was performed which showed the device had approximately 1. 4 years remaining until neos = yes (near end of service). The programming history database was reviewed; however, only information from 10/27/2010 through 12/15/2015 was available. No anomalies were noted within the available information. Information was later received confirming that the patient did have high impedance on (b)(6) 2016.
 
Event Description
An implant card was received showing the patient was re-implanted with a new generator and lead on (b)(6) 2016. The generator and lead were later received by the manufacturer for product analysis. During lead product analysis, a lead break was not confirmed. However, it should be noted that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be specs of white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur, and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during visual analysis, and no discontinuities were identified. Based on the findings in the pa lab, there was no evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the reported high impedance. Product analysis for the returned generator was also completed and found that the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

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dennis100
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« Reply #124 on: April 12, 2019, 12:17:00 AM »

Model Number 304-20
Event Date 05/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a vns patient's device showed low impedance at 600 ohms. No injuries, falls, or trauma were reported. It was stated by the patient's mother that they get efficacy from the magnet. The patient has been referred for full revision. Clinic notes were received indicating that the vns magnet was initially effective, but is now no longer effective. An increase in seizures since may 2016 was documented and was attributed to "vns dysfunction resulting in low impedance value on interrogation. " the device had been programmed off on (b)(6) 2016. Lead and generator revision surgery occurred on (b)(6) 2016. A lead break was visualized approximately one-third of the distance from the generator. The explanted devices have not been received to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: the relevant test data was inadvertently not included in the initial report.
 
Event Description
The explanted devices were received for analysis on 10/05/2016. Analysis was performed on the returned lead portion 10/24/2016. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The outer silicone tubing appeared to be twisted and abraded openings were observed on the outer and inner silicone tubes. The coils were bare and exposed in the areas of the abraded openings. The abraded openings found on the outer and inner silicone tubes, 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, sulphur and calcium. With the exception of the twisted appearance and abraded openings, the condition of the returned lead portions is consistent with those 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 portion were performed, during the visual analysis, and no discontinuities were identified. Analysis was completed for the returned generator 10/27/2016. The downloaded from the generator shows an indication of decreased impedance, as the last >25% change in impedance value showed the pre-change impedance value was 63 ohms and the post-change value was 257 ohms, with a time of change detection on (b)(6) 2016. The device was explanted later on (b)(6) 2016. Review of the manufacturer's programming history database shows the last known diagnostic test was performed on (b)(6) 2016 with an impedance value of 1812 ohms. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 055 volts and shows an intensified follow-up indicator was not set. 18. 519% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded generator data revealed no anomalies.

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« Reply #125 on: April 12, 2019, 12:17:49 AM »

Model Number 300-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Patient underwent explant due to pain as reported in mfr. Report # 1644487-2016-01153. An analysis was performed on the returned lead portions. The electrodes portion of the leads was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. Abraded openings were found on the outer and inner silicone tubing. These abraded openings 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the marked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the inner tubing abraded opening, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the 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, with no discontinuities identified. Based on the findings, there is evidence of an inner tubing abraded opening.

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« Reply #126 on: April 17, 2019, 06:29:44 AM »

Model Number 302-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Clinic notes were received for patient's referral for surgery due to high impedance. Clinic notes state that the vns is currently turned off secondary to high impendence and lead fracture. Notes also describe receiving a warning message about the device being able to deliver a maximum of 2 ma output current previously. Device diagnostics showed high lead impedance. No known surgical interventions have occurred to date.
 
Event Description
The patient underwent a full revision surgery on (b)(6) 2016. The explanted lead and generator were received on 10/04/2016. Analysis is underway but has not been completed to date.
 
Event Description
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, 3. 006 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of lead fracture and high impedance, which were confirmed. A large portion of the lead assembly (body) including the electrode section was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Analysis confirmed discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break areas were also observed. Flat spots and pitting were observed on the coil surface. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, which most likely completed the fracture on one of the broken coil strands. 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 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. 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.

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« Reply #127 on: April 19, 2019, 12:45:36 AM »

Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's device showed high impedance. The device was programmed off and patient was referred for lead revision and prophylactic generator replacement. Patient's mother reported that the patient's seizure activity has increased every day since device has not been working. No additional relevant information has been received to date. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon believes the single incision technique used during the initial implant surgery may have contributed to the lead break. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Event Description
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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portion of the device.

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« Reply #128 on: April 21, 2019, 03:25:01 AM »

Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's device showed high impedance. The device was programmed off and patient was referred for lead revision and prophylactic generator replacement. Patient's mother reported that the patient's seizure activity has increased every day since device has not been working. No additional relevant information has been received to date. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon believes the single incision technique used during the initial implant surgery may have contributed to the lead break. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Event Description
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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portion of the device.

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« Reply #129 on: April 24, 2019, 12:33:35 AM »

Model Number 302-20
Device Problems Mechanical Problem; Appropriate Term/Code Not Available
Event Date 12/08/2016
Event Type  Malfunction   
Event Description
During a generator replacement surgery, the old generator was unable to be interrogated. When the lead was connected to the new generator, high impedance was observed. The company representative performed 3 system diagnostics in a row. Each time, the output current was low, current delivered was 0. 25ma, and lead impedance was high >=10000 ohms. The old lead pin was fully inserted into the m 103 prior to system diagnostics. The surgeon looked under magnification to confirm, then disconnected lead, inspected lead and insertion point and confirmed again. High impedance was still present after confirming complete insertion. A full revision surgery was performed as a result. With the new lead connected to the new generator, impedance was within normal limits. The explanted lead has not been received to date.
 
Event Description
The generator and lead were received. Analysis is underway but has not been completed yet.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The reported ¿end of service and low battery¿ allegations on the generator were confirmed in the lab; an open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portions and the reported allegations of lead fracture and high impedance were confirmed. A portion of the outer silicone tubing and a portion of the connector ring quadfilar coil were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned lead, the lead coils appeared to be broken in several areas. Scanning electron microscopy performed on the several coil breaks identified the areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, some with pitting and some without pitting, evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of the broken coil strands. The area on one of the two remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. The area on the last broken coil strand was identified as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type. 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 of the returned 15mm portion the (-) green quadfilar coil appeared to be broken approximately 3mm past the end of the cut / torn inner silicone tubing. 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 slice mark 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 found inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the inner silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. 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.

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« Reply #130 on: April 24, 2019, 12:34:24 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 12/07/2016
Event Type  Malfunction   
Event Description
Patient was scheduled for a prophylactic generator replacement on (b)(6) 2016 due to ifi - yes. Prior to the surgery, high impedance noted in three times and twice again in the or. The generator was replaced first and the lead was connected to the new m 106 generator. High impedance persisted and so the lead was revised. Impedance was within normal limits after the lead revision. The explanted devices have not been received to date.
 
Event Description
The explanted lead and generator is believed to be discarded.
 
Event Description
The explanted generator and lead were received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
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. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegation of fracture of lead(s) was not confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found in the outer and inner silicone tubing, slice marks 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. White deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except the half set of set screw marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional set screw 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 discontinuities were identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portions of the device.

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« Reply #131 on: April 26, 2019, 05:59:52 AM »

Model Number 302-20
Device Problems High impedance; Mechanical Problem
Event Date 01/06/2017
Event Type  Malfunction   
Event Description
During an generator replacement surgery, high impedance warning message was seen upon interrogating the generator that was to be implanted; no system diagnostic was performed. The high impedance seen upon interrogation is expected since no system diagnostic cleared the stored value. System diagnostic test must be performed in order for the generator to test the impedance when connected to the lead, which was not performed during this surgery. During troubleshooting, the surgeon examined the lead and noticed that there was a small tear in the sheath of the lead near the lead tip that he believed could be causing the impedance issue. The surgeon also commented that the lead felt brittle and calcified and elected to replace the lead. The explanted lead has been received and is undergoing product analysis. No other relevant information has been received to date. Manufacturing report number 1644487-2017-03055 will discuss the detached septum plug that was observed for the generator during the same surgery.
 
Event Description
Product analysis was completed on the returned portion of the explanted lead. The electrode array was not returned along with a segment of the lead near the electrodes. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. White deposits were found along the body of the lead. Energy dispersive spectroscopy showed that the deposits consisted of phosphorous, calcium, and silicon. No discontinuities were identified on the portion of the lead that was returned. No anomalies were noted that impacted the functionality of the device. No additional information has been received to date.

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« Reply #132 on: May 01, 2019, 12:40:27 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
High impedance was observed with the patient's vns. Follow up with the nurse found that the patient came in on (b)(6) 2015 with their device disabled due to high impedance. The nurse turned that patient's device on and performed a lead impedance test. She then programmed the patient's device back off. The patient was recently referred for surgery. No surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
The patient underwent surgery in (b)(6) 2017 where the patient's lead was explanted. The explanted lead has been received and is undergoing product analysis.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided in follow-up report#1 that the explanted generator was received by the manufacturer also.
 
Event Description
The explanted generator was received by the manufacturer.
 
Event Description
Analysis was completed for the returned generator. Results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 968 volts and was not at an end-of-service condition. The downloaded data revealed that 15. 012% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed on the returned lead portions. The lead coil wires were found to be broken. Scanning electron microscopy was performed and identified extensive pitting. There was evidence of a rotational stress induced fracture. The area on the remaining broken coil strand was identified as having evidence of a fatigue stress induced fracture with mechanical damage, no pitting and evidence of a rotational stress induced fracture. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings, incision marks and slice mark found on the outer and inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of body fluids inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. 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.

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« Reply #133 on: May 09, 2019, 06:55:30 AM »

Model Number 302-20
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2017
Event Type  Malfunction   
Event Description
Patient reported that he is getting painful, jolting stimulation when he turns his head. The patient was seen by the neurologist, who stated that the patient was being referred for vns battery replacement due to battery near end of life. This was reported to be an intervention for the painful stimulation as the physician believes the vns nearing end of life is the cause of the pain. Information was later received that the device is at end of service and patient was referred for replacement. Patient visited the er for pain in the vns area. Clinic notes were received for the replacement referral, indicating that the magnet did not abort an seizure. The physician attributed this to the low battery of the generator. In clinic notes, neos - yes was marked. Patient underwent generator replacement surgery but the explanted generator will not be returned per the explant facility.
 
Event Description
After generator replacement, the patient reported that he was unable to feel both normal and magnet stimulation. Upon interrogation of the device a high impedance warning message was observed. Diagnostic testing was performed. Impedance was found to be ok, but on the higher end (5221 ohms) with low output status. The generator was only supplying 1. 625 ma when normal mode was programmed to 1. 75 ma. There appears to be an intermittent impedance issues. X-rays were performed and a very obvious lead fracture was observed. The patient did not remember any falls or trauma that could have caused it however he knew something was wrong because he could not longer feel magnet stimulation and he had an increase in seizures. Patient underwent lead revision and the surgery reportedly went well but took a lot of time to complete. The explanted lead has not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer. Analysis is underway but has not been completed.
 
Event Description
Analysis of the lead confirmed discontinuities of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break locations were also observed. Scanning electron microscopy was performed on quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface in some areas. During the visual analysis, the negative electrode quadfilar coil appeared to be broken approximately 1 mm from the end of the abraded open / cut / outer / inner silicone tubes and the positive white electrode quadfilar coil appeared to be broken at approximately 2 mm. 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 tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium sulphur and calcium. With the exception of the abraded openings observed on the outer and inner silicone tubes and 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 set screw 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6509179
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« Reply #134 on: May 14, 2019, 12:17:53 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/08/2016
Event Type  Injury   
Event Description
The nurse practioner is referring patient for full revision due to migration. Replacement was stated to be necessary because patient's current vns has migrated to the edge of the chest wall, rendering access very difficult. No known surgical interventions have occurred to date. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the device migration occurred between visits in (b)(6) 2016 and (b)(6) 2017. There are no known causes for the migration such as trauma or manipulation. Surgical intervention is planned to preclude a serious injury. The previous implant surgeon confirmed that a non absorbable suture was used to secure the generator to fascia during the implant. No known surgery has occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were received. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There are no performances or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway but has not been completed to date.
 
Event Description
Analysis of the received lead was completed. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. 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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw 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 portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device.

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« Reply #135 on: May 18, 2019, 12:34:40 AM »

Model Number 300-30
Device Problem Fluid Leak
Event Date 01/26/2017
Event Type  Malfunction   
Event Description
A patient¿s lead and generator were explanted in order to participate in a clinical trial of another device. The explanted devices were received for analysis by the manufacturer. Analysis was completed for the returned generator. The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis was completed on the returned lead portions. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. 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 inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the 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. With the exception of the abraded openings, no other obvious anomalies were noted. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6593215
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« Reply #136 on: May 30, 2019, 05:53:41 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/23/2017
Event Type  Injury   
Event Description
A physician stated that during a generator replacement surgery, he identified that a patient had some foreign white substance identified in the generator pocket. Follow-up was performed and the physician's op notes stated that the physician saw something resembling a plastic coating on the fascia under the generator incision site, but that all the scar tissue was normal. The patient was seen post-op and reportedly not experiencing any adverse events related to the surgery and was healing normally. The explanted generator was returned to the manufacturer for analysis which has not been completed to date. No further relevant information has been received to date.
 
Event Description
The explanted generator had analysis completed where the generator diagnostics were as expected for the programmed parameters. The device passed a comprehensive automated electrical evaluation. The stored data showed normal battery consumption and normal impedance values pre-operatively. There were no performance or any other type of adverse condition identified with the generator.

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« Reply #137 on: May 30, 2019, 05:54:23 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 04/12/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient was referred for a full revision. Clinic notes were received from visits on (b)(6) 2017 regarding a full revision for high impedance. On (b)(6) 2017 it was provided that the patient's seizure control is worse since the last visit. The physician stated that the vns had high lead impedance. On the visit on (b)(6) 2017 x-rays were reviewed and it was provided that the lead has fractured upon review of the x-rays. Surgery occurred and the explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Event Description
Analysis was completed for the returned 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. The battery measured 2. 947 volts during the electrical test, and shows the battery was not at an end-of-service condition. The data showed that 80. 131% of the battery had been consumed. An 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 attributed to clinical use of the device. Analysis was completed for the returned lead portions. The coil appeared to have dissolved in some areas with a greenish tint observed inside the inner silicone tubing. The connector pin coil appeared to be broken scanning electron microscopy was performed coil break and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type. The remaining broken coil strand appeared to be mechanically damaged. The abraded openings 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. What appeared to be white deposits were observed in various locations. No other 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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« Reply #138 on: May 30, 2019, 05:55:07 AM »

Model Number 300-20
Device Problems High impedance; Mechanical Problem
Event Date 05/19/2017
Event Type  Malfunction   
Event Description
A prophylactic generator and lead replacement was planned due to desire for the latest model generator that has the autostim feature as the patient has approximately 30 grand mals a month 38; nocturnal seizures. During the surgery, high impedance was observed with the existing devices. Both lead and generator were replaced and the high impedance resolved. Company representative reported observing the lead wire without the insulation. The explanted generator and lead were received. Analysis is underway but has not been completed to date.
 
Event Description
An end-of-service warning message was verified in the lab for the explanted generator and found to be associated with the output being disabled by the pulse 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. A large 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. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw 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 discontinuities were identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portions of the device.

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« Reply #139 on: June 06, 2019, 01:41:51 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Patient underwent explant of vns generator and lead as patient felt that it never helped. The device was reported to have been disabled for years prior to explant. Analysis was performed on the returned lead portions. During the visual analysis, the lead coil appeared to be broken. Scanning electron microscopy was performed on the coil break and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Two of the broken coil strands appeared to have evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Residual material was observed on the coil surface. The remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. 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 and slice marks 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon and phosphorus. With the exception of the observed abraded openings and discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Since a portion of the lead assembly including the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #140 on: June 10, 2019, 12:12:28 AM »

Model Number 302-20
Device Problem Fracture
Event Date 08/16/2017
Event Type  Malfunction   
Event Description
Report received that high impedance was found after performing system diagnostics on new generator in the operation room. The patient was scheduled for a generator replacement due to battery depletion, and the generator was unable to be interrogated. When the new generator was implanted and connected to the lead, a system diagnostic was run and showed high impedance. The lead was explanted. Further information was received that during the surgery, the lead pin was confirmed to be inserted into the generator properly. Generator diagnostics were also performed on the new generator and the results showed normal impedance. A review of the programming history did not indicate whether or not high impedance was seen prior to the replacement. Recent system diagnostics prior to surgery could not be provided by the patient's physician. The lead and generator were explanted and received by the manufacturer, but analysis has not been approved to date. No other relevant information has been provided to date.
 
Event Description
Product analysis was completed on the generator. The generator could not be interrogated due it reaching normal battery depletion. A review of the generator data showed a 26. 3% change in impedance. The pre and post change impedance values were both normal. The data did not show the onset of high impedance as the battery became too depleted to perform automeasures for impedance. The measured battery voltage was consistent with the estimated charge consumed. No further relevant information has been received to date.
 
Event Description
Further information was received that product analysis was completed on the lead. The lead was returned in two portions. Visual examination showed one portion had stretched and kinked quadfilar coils. On this portion, set screw marks were present and white deposits were observed in various locations. Abrasions were also noted on the connector boot. Dried remnants of what appeared to be bodily fluids were inside the outer silicone tubing. Other abraded openings were seen along the outer tubing of this portion. On the second portion, white deposit was also seen. Besides typical markings and damage associated with explant, no visual anomalies were noted. No discontinuities were found during the continuity checks for the returned portions. However, there was a portion of the lead which included the electrodes which was not returned for analysis and an assessment on that portion could not be made. No further relevant information has been received to date,.

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« Reply #141 on: June 12, 2019, 02:28:15 AM »

Model Number 300-20
Device Problems Corroded ; Mechanical Problem
Event Date 09/08/2017
Event Type  Malfunction   
Event Description
Report received that a patient's lead was found to be corroded after explant. The reason for the lead explant was initially unknown. The patient was originally scheduled for a generator replacement due to end of service. However, both the lead and generator were replaced. Lead information was illegible due to corrosion covering the labeling. Further information was received that the lead was explanted because it was not compatible with the new generator. System diagnostics had been performed about 4 months prior to explant and results were normal. A review of the device history record indicated all quality inspections were performed and passed prior to release for distribution. The lead was returned and received by the manufacturer. Product analysis has not been completed on the lead to date. No further relevant information has been provided.
 
Event Description
Product analysis was completed on the lead. Product analysis was completed on the lead. A section of the lead assembly was returned for analysis in two pieces with the lead connector still attached to the pulse generator header. The electrodes were not returned for analysis and an assessment could not be made. Photograph and x-ray images showed that both the marked and unmarked portions were not fully inserted. However, a continuity check was performed and indicated proper contact was still made. It was also found that the lead connectors were incorrectly inserted with the marked (positive) connector in the negative cavity of the pulse generator header. The first portion of the retuned lead was inspected. Three set screw marks were seen providing evidence that proper contact had been made at one time. A single set screw indentation was noted at the end tip of the marked connector pin. Abrasions were noted on the connector boot. White deposits were also noted on the connector boot. Abrasions were noted on the silicone tubing of the marked connector. The positive coil had a spiral/wavy appearance. The second portion of the lead was also visually inspected. Three set screw marks were seen providing evidence that proper contact had been made at one time. The marked connector pin had an opaque appearance in the vicinity of the set screw marks. Abrasions were also noted on the unmarked connector boot. White deposits were noted on the unmarked connector boot. Abrasions were noted on the silicone tubing of the unmarked connector. The unmarked connector appeared to have been torn at the connector bifurcation. No discontinuities were identified within the returned lead portions. Scanning electron microscopy images of the unmarked connector pin at the opaque appearance region shot that pitting or electro-etching conditions have occurred on the surface of the pin. An energy dispersive spectrometry analysis performed on a sample of the white deposits identified the composition of the substance. No further relevant information has been received to date.

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« Reply #142 on: June 15, 2019, 10:49:55 PM »

Model Number 302-20
Device Problems Fracture; Appropriate Term/Code Not Available
Event Date 01/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a consult for generator replacement due to battery depletion, a lead fracture was observed in x-rays. The generator battery was reported to be dead. Both the generator and lead were replaced. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative

Event Description
During the visual analysis, multiple quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture. Determination could not conclusively be made on the fracture mechanism. Pitting and residual material were observed on the coil surface. Scanning electron microscopy identified an area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on one and residual material on the other two broken coil strands. 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 opening / torn areas 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. Since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #143 on: June 23, 2019, 03:34:20 AM »

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

Event Description
It was reported that prior to a generator replacement case, high impedance was detected on the patient's generator. The device was programmed at 2. 75ma and the current delivered was 0. 75ma. There were no visible fractures, but at the end of the lead that inserts into the generator there was a white material on the outside of the lead. The surgeon did try to remove it, but nothing would come off. The lead and generator were replaced. The explanted products were received but product analysis has not been completed on the suspect device has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned lead. The lead was returned in 5 portions with the anchor tether and second electrode not returned. A coiled portion of the lead was encased in a large piece of body tissue. There were white deposits along the lead bod, which; energy dispersion spectroscopy found to contain silicon, phosphorus, sodium, magnesium and calcium. Product analysis identified two lead fractures in the lead body. With regards to the first fracture, scanning electron microscopy found that one strand break had evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The other three strand breaks' fracture mechanism could not be identified due to mechanical damage. Pitting/corrosion was observed in the area of the fracture. With regards to the second fracture, scanning electron microscopy found that three of the coil strands at the fracture had evidence of a stress induced fracture (fatigue appearance. The final strand's fracture mechanism could not be identified due to mechanical damage. Corrosion was observed in the area of the second fracture. The corrosion at the lead fracture sites provides evidence that stimulation was present for some time after the fractures occurred. Finally, an abraded opening in the inner and outer tubing at the location of one of the lead fractures. Two other abraded opening were identified in the outer tubing. These openings provided a leakage path for body fluids into the inner and outer tubing. No further anomalies were identified. Product analysis was completed on the returned generator. As received, the generator was in near end of service condition (neos-yes). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and was in ifi-yes condition. No further relevant information has been received to date.

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