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Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.(b)(4).
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Event Description
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It was reported that the patient is experiencing migration, pain, painful stimulation, dysphagia, tremors, (muscle spasms) and voice alteration.The patient has been referred for surgery as a result.The patient was noted to have lost significant weight which resulted in this migration.Per the physician, the cause of the dysphagia and painful stimulation is vns stimulation.The cause of the voice alteration tremors and pain is the presence of the vns.No other relevant information has been received to date.No known relevant surgical intervention has occurred to date.
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Event Description
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The patient underwent a full revision due to the device shocking the patient per the implant card.The explanted devices have not been received to date.No abnormal diagnostics were reported pre-operatively.No other relevant information has been received to date.
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Event Description
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It was reported that the explanting facility does not have the explanted device.No other relevant information has been received to date.
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Search Alerts/Recalls
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