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Author Topic: Right Sided  (Read 35973 times)
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dennis100
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« Reply #120 on: June 11, 2019, 12:40:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient who was recently implanted has a golf ball sized lump over his generator. There is no redness or obvious signs of infection. The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder. The patient reported that the chest has become swollen like a golf ball. It is slightly warm to the touch, but not red. The patient saw the surgeon the surgeon decreased his output for the time being. It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep. The patient was advised not to bother the site and prescribed antibiotics. No additional relevant information has been received to date.
 
Event Description
Information was received indicating that the patient's lead came out of his neck incision. The physician's believe the patient has been picking at the site. It was indicated that the surgeon will be moving the patient's current vns system to his right side and checking lead integrity. The patient will also be placed on doxycycline for infection. Images were received that showed that the patient¿s lead is extruding out of his neck incision as well. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6958245
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dennis100
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« Reply #121 on: June 28, 2019, 10:05:46 PM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance
Event Date 02/13/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient's device was found to show high lead impedance. It was noted that if the leads were revised, the generator would also be prophylactically replaced to minimize number of surgeries for the patient. No surgery has occurred to date. No additional relevant information has been received to date.
 
Event Description
A full revision surgery occurred. It was noted that the patient's replacement lead was implanted on the right vagus nerve due to fibrosis on the left vagus nerve. It is indicated per labeling that fibrosis between the nerve and electrode is a possible cause of high lead impedance. Follow up with the physician's office provided the settings and diagnostics of the patient's device prior to replacement. The system diagnostics indicated high impedance, end of service (eos) = no. No devices were received to date. No additional relevant information was received to date.
 
Manufacturer Narrative

Event Description
The patient's explanted devices were returned for analysis. Product analysis was completed for the generator and lead. The generator performed according to functional specifications and analysis of the device found no abnormalities or malfunctions. The explanted lead was returned in five portions. Visual examination of the portions found that the setscrew marks were observed on the connector pin, indicating a proper mechanical contact between the conductive surfaces of both the generator and connector pin, ensuring a good electrical connection with the lead. The quadfilar coil 1 appeared to be broken near the anchor tether. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged, with pitting and residual material. Pitting was observed on the coil surface, and was likely related to stimulation present for a certain period of time. No other anomalies were noted. Based on the findings from product analysis, there was evidence to suggest a discontinuity in the returned portions of the device. Note that since the positive and negative electrodes were not returned, no analysis could be performed on those portions of the lead. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7326901
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