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Author Topic: Erosion  (Read 4984 times)
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dennis100
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« Reply #30 on: February 13, 2019, 02:53:55 AM »

Model Number 105
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported on (b)(4) 2015 that a patient¿s device was explanted on (b)(6) 2015 due to infection and erosion. There was nothing suspected to be wrong with the device, just that it had eroded through the skin. The lead and generator were received for analysis on 02/02/2015. Product analysis for the lead 302-20 was completed and approved on 02/19/2015. A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The 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 one and a half sets 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. Product analysis for the generator is underway but has not been completed to date. Attempts for additional information have been made and have been unsuccessful to date.
 
Event Description
It was clarified from the physician that the skin erosion was not a lead issue but skin eroded over the generator with breakdown along the incision line. There was no gross sign of infection although clear contamination was present. The culture taken was positive for propionibacter although it was unable to tell if this was infection or contamination from adjacent skin. Therefore, primary infection was not suspected but contamination/infection after skin erosion may be more likely situation.
 
Event Description
Product analysis for the patient¿s m105 device was completed and approved on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 013 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts have been made for further information but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4542162
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dennis100
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« Reply #31 on: April 19, 2019, 01:24:31 AM »

Model Number 101
Event Date 11/01/2016
Event Type  Injury   
Event Description
An implant card was received by the manufacturer notifying that vns patient underwent full revision surgery due to skin erosion. The lead impedance was checked after surgery and marked ok on the implant card. Review of manufacturing records confirmed all tests passed for the device prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Further clarification was obtained from site that the patient has got some hit on chest and the skin went sore.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6131239
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dennis100
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« Reply #32 on: April 24, 2019, 02:13:01 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/06/2016
Event Type  Injury   
Event Description
It was reported that a patient had a significant infection at her vns site shortly after implant. The infection was treated with antibiotics and got better, but the patient presented later with drainage from her vns site and signs of infection. Cultures were performed, and the patient was referred to the surgeon. The device history records of the generator and lead were reviewed, and both devices were sterilized prior to release. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? no. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Additional information was received that the patient underwent generator replacement surgery. The generator was replaced because patient's skin at generator site eroded and the generator was exposed. The surgeon removed it from the pocket on the left side and implanted the new generator on the right side. The explanted generator was discarded. According to the neurologist, the infection was ongoing. It would clear up for sometime and then come back. Based on that he made decision to replace the generator and move pocket to right side of her chest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6193059
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dennis100
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« Reply #33 on: May 03, 2019, 02:23:25 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434719
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dennis100
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« Reply #34 on: May 09, 2019, 07:21:37 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2017
Event Type  Injury   
Event Description
It was reported that the patient developed an infection at the generator site after replacement of her previous generator due to skin erosion and poor wound-healing, as captured in mfr. Report # 1644487-2017-03106. A review of the manufacturing records confirmed sterilization of the suspect generator. No known surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that both the patient's generator and lead were explanted due to the infection. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6377854
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dennis100
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« Reply #35 on: May 11, 2019, 02:14:32 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an infection, which led to the removal of their vns generator and a wound debridement. The patient's neurologist indicated that the reason for the generator pocket infection was unknown. It was reported that prior to generator explant, the generator was visible, likely due to the infection per the physician, and that the patient had a history of wound dehiscence, generator migration, and erosion through the skin. The patient's leads were initially left and the patient was treated with iv antibiotics for 10 weeks. The patient was hospitalized due to worsening condition of the neck area, that had began to drain due to infection, and the lead was infected and extruding through the skin as well. The patient additionally had a red "pimple-sized" bump at their neck incision site where the lead was coming through. The patient then had their vns leads removed on (b)(6) 2018 due to the reported infection and foreign body response. The patient had discomfort at their neck due to the reported lead extrusion. The patient had their vns electrodes removed on (b)(6) 2019 due to the infection, foreign body response, and discomfort at neck caused by the presence of the electrodes. A review of the device history records verified that the implanted products were sterilized and passed all functional specifications prior to distribution. Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506142
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dennis100
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« Reply #36 on: June 23, 2019, 03:50:51 AM »

Model Number 304-20
Device Problems Corroded ; High impedance; Appropriate Term/Code Not Available
Event Date 11/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was seen on the patient's device. The lead was replaced but the generator was not replaced. The explanted lead has not been received to date.
 
Event Description
The explanted lead was received. Analysis is underway but has not been completed.
 
Manufacturer Narrative
 
Event Description
Abraded openings were noted on the outer and the inner silicone tubing of the returned lead portions. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. The reported fracture of lead was verified. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. The positive coil shows what appears to be wear (smoothed surfaces) at the mate end in the vicinity of the break location. Also, the appearance of the positive coil mate end suggests a stress-induced fracture occurred in at least one strand of the quadfilar coil. Due to metal dissolution and or mechanical distortions (smoothed surfaces) the fracture mechanism of other strands cannot be ascertained. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
Additional information was received that the high impedance was first observed. The explanted lead was reported to be eroded or corroded into the jugular vein. No additional relevant information was received.
 
Event Description
No known interventions were taken specifically for the corrosion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7143722
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