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Model Number 1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphagia/ Odynophagia (1815); Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/02/2023 |
Event Type
Injury
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Event Description
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It was reported that immediately after the patient was implanted they had worsening voice alteration, increased difficulty swallowing, chills and shortness of breath and went to the emergency room.The patient was later hospitalized that same day due to a diagnosis of pneumonia.Additionally it was noted that the patient suffered from a vagal nerve injury that as resulted in vocal cord paralysis.No other relevant information has been received to date.
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Manufacturer Narrative
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F10 health effect, clinical code: code e2402 utilized; appropriate term ¿voice alteration¿ is not available.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿chills¿ is not available.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.Health effect - clinical code :e012202; health effect - clinical code :e2402; health effect - clinical code :e0733.
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Event Description
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Additional information was received reporting bilateral hearing loss and tissue damage from surgery no other relevant information has been received to date.
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Manufacturer Narrative
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A2 age at the time of event, corrected data - the initial reporter inadvertently used the wrong age for the patient.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿tissue damage¿ is not available.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿bilateral hearing loss¿ is not available.F10 health effect, clinical code, corrected data: the initial reporter inadvertently used e2402 for & voice alteration which was already captured in an existing code already used and did not need to be used.
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Search Alerts/Recalls
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