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Author Topic: Jugular/Carotid  (Read 15699 times)
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dennis100
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« Reply #60 on: April 06, 2019, 02:39:49 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/29/2018
Event Type  Malfunction   
Event Description
It was initially reported that the patient was scheduled for a full revision surgery for an unknown reason. Information was later received that the patient¿s generator and lead were replaced due to high impedance. It was also reported that during the surgery the patient¿s jugular vein was nicked which resulted in bleeding and was repaired by a general surgeon. A review of device history records for the lead and generator shows that no unresolved non-conformances were found. The devices met all specifications for release prior to distribution. The explanted generator and lead have been received. Analysis is underway but has not been completed to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8390122
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dennis100
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« Reply #61 on: June 17, 2019, 04:46:10 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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dennis100
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« Reply #62 on: July 05, 2019, 11:33:39 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr: device evaluation is not necessary as the hemorrhage is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a clinical trial patient experienced a 2mm hemorrhage. The patient was to be implanted however due to the hemorrhage, they did not move forward with the implantation. It was stated that the hemorrhage occurred during surgery, and was due to the surgeon cutting through a particularly fibrous area which had caused a 2mm incision in the jugular vein. It was stated that this was sutured and rectified immediately and the implant was abandoned. It was reported the surgery did not move forward for the patient's safety. It was stated that the physician does alleged the hemorrhage due to the vns surgery as it is documented in the patient's electronic records that it had occurred while creating the incision for the implant. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8721968
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