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dennis100
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« Reply #30 on: February 21, 2019, 11:28:10 AM »

Model Number 300-20
Event Date 03/02/2015
Event Type  Malfunction   
Manufacturer Narrative
Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to a reported lead fracture and battery depletion. Attempts for additional relevant information have been unsuccessful to date. The explanted devices were returned to the manufacturer. Analysis is underway, but it has not been completed to date.
 
Event Description
It was reported that the patient¿s vns system showed high impedance. It was reported that x-rays would be taken, but they have not been provided to the manufacturer to date. No known surgical interventions have occurred to date.
 
Event Description
Analysis of the lead confirmed a discontinuity of the negative quadfilar coil in the electrode region of the returned lead portions. The unmarked connector pin quadfilar coil appeared to be broken. Four broken coil strands were identified with two showing evidence of a stress induced fracture with mechanical damage and fine pitting. The area on a third was identified as being mechanically damaged. 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. 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. White deposits were found in various sites which contained silicon, phosphorus, sodium, magnesium, chlorine, aluminum, sulphur and calcium. With the exception of the observed discontinuity, the returned lead portion shows a condition that is consistent with an explant procedure. No other obvious anomalies were noted. Analysis of the generator found that the battery was at end of service due to normal battery depletion. The device exhibited current consumption rates that are within specification. The pulse generator module performed according to functional specifications.
 
Manufacturer Narrative
Describe event or problem ; corrected data: the previously submitted mdr inadvertently provided an incorrect event description.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4686639
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dennis100
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« Reply #31 on: February 25, 2019, 01:15:11 AM »

Model Number 302-20
Event Date 04/14/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. Clinic notes dated (b)(6) 2015 note that the patient has experienced a dramatic increase in seizures since the last office visit. It was noted that there was an increase in device impedance and that may be why the patient is having increased seizures. It was reported that there is no known trauma or patient manipulation that may have caused the high impedance. It was reported that the seizures were above the patient's pre-vns baseline frequency. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient underwent generator and lead replacement due to high impedance. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the returned generator was completed on (b)(4) 2015. The generator performed according to functional specifications. Analysis in the product analysis lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2015. Note that 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 (-) connector pin quadfilar coil appeared to be broken approximately 306mm 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 with residual material. 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. During the visual analysis the (+) connector ring quadfilar coil appeared to be stretched and kinked approximately 273mm past the end of the cut / torn inner silicone tubes with a spot-weld / slug attached to the end. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. The abraded openings and 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 silicone tubing. The abraded openings found on the (-) connector pin 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 what appeared to have once been body fluids found inside the inner silicone tubing. For the observed dried remnants of what appeared to have once been body fluids found inside the (+) connector ring inner silicone tubing, 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 on the outer silicone tubing. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuity the condition of the returned lead portion 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 portion 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=4757575
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dennis100
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« Reply #32 on: February 26, 2019, 01:18:28 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Connection Problem
Event Date 05/12/2012
Event Type  Malfunction   
Event Description
Product analysis (pa) for the returned generator was completed. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications, with the exception of the test "backup cap neg to can", which has already been captured in mfr. Report 1644487-2017-03534. There were no additional performance or any other type of adverse conditions found with the generator. Pa for the returned lead was completed. Allegations of lead fractures were confirmed. The electrodes were not returned for analysis; therefore, a complete evaluations could not be performed on the entire lead product. During the visual analysis, the outer silicone tubing appeared to be twisted and compressed in several areas. Fractures were identified and scanning electron microscopy found that they were stress induced fractures. Additionally, pitting was observed on the surface of some of the breaks. 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 was performed on one of the deposits and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium. With the exception of the observed discontinuities and the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Based on the findings in the pa lab, there is evidence to suggest discontinuities in the returned portion of the device, which may have contributed to the stated allegations of lead fractures. Note that since the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported the patient has been referred for replacement surgery; however, no surgical intervention has taken place to date.
 
Event Description
Clinic notes dated (b)(6) 2015 note that the patient and her mother feel that the vns was injured or disconnected the year prior and that device diagnostics were within normal limits. It was noted that there was a tightness in the lead that the neurologist was concerned about. The surgeon noted that there is no unusual tightness of the lead. An x-rays assessment was received indicating that the lead wire was disconnected from the device in the left neck. It was reported that device diagnostics performed on (b)(6) 2014 were within normal limits (1704 ohms). The neurologist believes that scar tissue is the reason for the lead tightness feeling that the patient experiences. The neurologist indicated that the patient's parents have asked for the generator and lead to be replaced. X-rays were sent to manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes. It was later reported that high impedance was observed and that revision surgery was planned. A fluoroscopy was performed by the surgeon who found that the lead could not be seen clearly and concluded that the lead may have never been connected. Recent diagnostics were found in the physician's programming system that showed that device diagnostics were within normal limits at one time which showed that the device was at one time connected. The patient was seen on (b)(6) 2015 at which time device diagnostics were within normal limits. It was reported that the device was functioning normally and was programmed back on. The cause of the diagnostics being within normal limits is a believed short circuit situation with the patient's tissue. A device decoder was performed which identified that the lead break likely occurred as early as (b)(6) 2012. The patient was referred back to surgeon. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Age at time of event; corrected data: this information was inadvertently reported incorrectly on initial mfr. Report.
 
Event Description
The explanted generator and lead were received by the manufacturer on 03/02/2017. While analysis is expected, it has not been completed to date.
 
Event Description
Additional x-rays were sent to the manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes confirming a lead break.
 
Event Description
The patient underwent a full vns revision on (b)(6) 2016. It was noted when the lead was removed, it appeared to be fractured and the lead wires were twisted together. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4749594
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dennis100
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« Reply #33 on: March 13, 2019, 12:20:22 AM »

Model Number 300-20
Device Problems Break; Calcified
Event Date 08/05/2015
Event Type  Malfunction   
Event Description
Product analysis for the returned lead was completed. It was noted that a portion of the lead assembly, including the electrodes, was not returned for analysis. White deposits were observed in various locations. The deposits were analyzed with energy dispersion spectroscopy which identified silicon, phosphorus, sodium, magnesium, and calcium. During visual analysis, three areas of the coil strands were identified as having the appearance of being melted, with re-solidified material. Based on obvious signs of mechanical damage on the coil surface, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of the lead. There were also two stress-related fractures noted on the lead. The stress fractures were due to rotational forces, which most likely completed the fracture with mechanical damage. A third region of the coil appeared to be stretched, kinked, and extended past the end of the cut/torn outer and inner silicon tubes. Determination could not be made if the end was cut. The condition of the returned lead portion 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 near the end of the marked connector pin, indicating the lead had not been fully inserted into the cavity of the generator at one time. However, additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks on the unmarked 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 discontinuity was identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the lead.
 
Event Description
Both the lead and the generator were received by the manufacturer. Product analysis for the returned vns generator showed the generator was noted to perform according to functional specifications. Analysis of the vns generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead is expected but has not been completed to date.
 
Event Description
It was reported the lead was found encapsulated by calcification at the site of the vns generator. When the generator was removed from the pocket, the lead was found to be damaged. Due to the lead damage, the lead was replaced. It was reported the vns device was tested during the pre-operative evaluation and no high impedance was noted. The suspect device is expected to be returned, but has not been received to date.
 
Manufacturer Narrative
Evaluation, results and conclusions; corrected data: this information was inadvertently left off of the supplemental #02 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5051717
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dennis100
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« Reply #34 on: March 16, 2019, 12:11:42 AM »

Model Number 302-30
Device Problems Break; High impedance
Event Date 05/17/2015
Event Type  Malfunction   
Event Description
It was reported by the neurologist the patient was scheduled for vns surgery as the vns was checked showing high impedance and it is unsure if the lead pin is out or if a new lead needs to be placed. It was also reported the patient's device was turned off on (b)(6) 2015. It was later reported the patient underwent surgery on (b)(6) 2015 and the lead and the generator were both replaced. The lead was replace due to high impedance and the generator was prophylactically replaced. Additionally, it was reported there was a lead break at the strain relief bend, right by the tie down. It was also clarified the generator was replaced prophylactically as the physicians were unclear how long the device had been broken and were not comfortable using the old device due to the broken lead and risk of infection from taking the generator out, then putting it back in after removing and replacing with the new lead. The lead and the generator were received. Analysis is expected but has not been completed to date.
 
Event Description
Product analysis found that the high impedance most likely occurred on (b)(6) 2015 as the impedance value was noted to have changed from 1224 ohms to 11619 ohms on that date. It was found through testing that the generator performed according to functional specifications. The final electrical test shows and ifi = no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed on the returned lead portions and lead fractures were confirmed. It should be noted that portions of the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Fractures were found on all three coil strands. One of the coils had extensive pitting that prevented identification of the fracture type. It was noted that all three broken coil strands were mechanically damaged which prevent identification of the fracture type, with evidence of a stress induced fracture, which most likely completed the fracture on all three broken coil strands. One of the coil strands was identified as having evidence of a stress induced fracture with mechanical damage and pitting. Determination could not conclusively be made on the fracture mechanism. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer silicone 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. Energy dispersion spectroscopy was performed on the deposit observed on the connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium. It was found that the returned 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 exception of the observed discontinuities 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 pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the stated allegations.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #01 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5126663
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dennis100
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« Reply #35 on: March 19, 2019, 12:20:22 AM »

Model Number 300-20
Device Problem High impedance
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital due to an increase in seizures. A system diagnostic test was later performed for patient and high impedance with dcdc 7 was observed. Additional information was obtained that the patient was discharged then re-admitted due to a generalized seizure. Patient was referred for replacement surgery and underwent full revision surgery on (b)(6) 2015. The explanted products are expected to be returned but have not been received to date.
 
Event Description
Generator and lead were returned due to lead discontinuity and were received on 11/30/2015. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. Analysis of the lead is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of ¿fracture of leads and high impedance¿ were confirmed. A portion of inner silicone tubing and quadfilar coil between the electrode bifurcation and anchor tether 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 electrode region of the returned lead portions. Scanning electron microscopy was performed on the area of the break on quadfilar coil 1; the remaining coil strand was 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. Flat spots and pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break area and the area was identified as having extensive pitting which prevented identification of the coil fracture type. Flat spots and 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 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. 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, sulphur and calcium. Refer to attached eds sheet for additional information. 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 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5246076
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dennis100
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« Reply #36 on: Today at 12:11:59 AM »

Model Number 302-20
Device Problem High impedance
Event Date 11/23/2015
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system on (b)(6) 2015. It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 for prophylactic reasons. The diagnostic results in or and since have been good (dcdc 2), until on (b)(6) 2015 where the normal and system diagnostic testing showed high impedance (dcdc 7). X-rays were taken and sent to the manufacturer for review. The generator appears to be placed in the upper chest in normal arrangement. The pin connector is fully inserted. The electrodes appeared to be placed in normal arrangement. Strain-relief bend and loop seemed to have been used. One tie-down was found (visible) holding the lead but not as specified in labeling. A portion of lead behind the generator could not be assessed. No suspected lead break was found on the visible part of the lead. It was reported that the device was turned off on (b)(6) 2015. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with was 1345 ohms. It was reported that the generator was replaced due a generator issue. This event is reported in the medwatch number 1644487-2016-00042. Return of the explanted devices to the manufacturer is expected but they have not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer on 01/08/2016. Analysis of the returned lead portions was completed and the reported allegations were confirmed. During the visual analysis of the returned 218mm portion quadfilar coil 2 appeared to be broken approximately 194mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy (sem) was performed on the connector end of the quadfilar coil 2 coil break (found at 194mm) and identified the area on two of the broken coil strands 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 on one of the broken coil strands. The area on the remaining broken coil strands 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. Flat spots were observed on the coil surface. Sem was performed on the electrode (mating) end of the quadfilar coil 2 coil break (found at 194mm) and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. 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 connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium 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. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5297221
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