Model Number 105 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 08/27/2018 |
Event Type
Injury
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Event Description
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It was reported that the patient's generator had migrated from the chest pocket to the patient's nipple.It was reported that surgery was being sought to fix the positioning of the generator.No relevant surgical intervention is known to have occurred to date.No additional or relevant information has been received to date.
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Event Description
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It was reported that the patient was referred for vns generator replacement.No known surgery has occurred to date.No additional or relevant information has been received to date.
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Manufacturer Narrative
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Device evaluation is not necessary because the reported event has been determined as not related to vns therapy, but rather to the presence of the device and device evaluation will provide no additional value to the investigation.
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Event Description
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Information was received that the patient underwent a generator replacement surgery.No additional or relevant information has been received to date.
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Search Alerts/Recalls
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