Model Number CI-1500-04 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Seroma (2069)
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Event Date 03/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient is reportedly doing fine.The recipient is using the device.The recipient remains implanted.This is the final report.
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Event Description
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The recipient reportedly experienced a seroma.On (b)(6) 2017, the recipient underwent a skin flap surgery to improve the area of the seroma.
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Manufacturer Narrative
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The recipient's seroma has reportedly recurred and the skin flap is necrotic.The recipient was prescribed cefuroxime.The recipient's device was explanted.The recipient was not reimplanted.
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Manufacturer Narrative
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(b)(4).The recipient is reportedly very well.The external visual inspection revealed the electrode was severed near the array prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented one of the electrical tests performed.The device passed all of the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is this final report.
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Search Alerts/Recalls
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