Model Number CI-1500-01 |
Device Problem
Expulsion (2933)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/07/2024 |
Event Type
Injury
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient reportedly experienced a skin flap infection with device extrusion.The recipient was admitted to the hospital.The recipient's device was explanted.The recipient will be reimplanted at a later date.
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Manufacturer Narrative
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The recipient reportedly received medical treatment (type unknown) prior to revision surgery.The infection is not believed to be device related.The recipient has reportedly healed.A review of the device history record was performed at the request of the nca and no anomalies were noted.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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