Model Number 1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 12/20/2018 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced pain at generator site following their generator replacement surgery.The patient was referred for generator re-positioning surgery due to their discomfort.It was also reported that the patient's discomfort was preventing them from having a mammogram due to possible breast cancer and that the vns generator had migrated to the areola, causing the discomfort.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.
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Event Description
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It was reported that the patient's generator was anchored to the chest wall with non-absorbable silk suture, per labeling.No further relevant information has been received to date.
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Event Description
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Information was received that the patient had the vns generator and part of the lead removed.The suspect device has not been received by the manufacturer to date.No additional relevant information has been received to date.
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Search Alerts/Recalls
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