Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 11/28/2018 |
Event Type
Injury
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Event Description
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It was reported that the patient was experiencing pain at the generator site, which was at the left armpit due to a chest tattoo.The device was causing discomfort due to being much larger (m106) than the patient¿s previous m103.The patient has a follow-up appointment with the surgeon to discuss moving the vns generator.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.
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Event Description
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It was reported that the patient was scheduled for surgery, but the surgery was canceled due to a non-related vns illness.Therefore, the report from the surgeon that he had "replaced the patient's vns at the same place as before" was likely a reference to the initial replacement surgery and not any intervention taken recently.No relevant surgical intervention is known to have occurred to date.
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Event Description
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Follow up with the physician's office revealed that the surgeon had "replaced the patient's vns at the same place as before." it was unclear what was meant by this and the physician did not wish to provide any further information.
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Event Description
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The patient underwent vns generator repositioning surgery.A new generator pocket was made towards the middle of the patient's chest.The lead was tunneled to the new pocket, diagnostics were performed, and the patient was closed.
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Search Alerts/Recalls
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