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Model Number CI-1600-04 |
Event Date 07/09/2018 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing lock issues.The recipient underwent debridement surgery, however, the issue did not resolve.On (b)(6) 2018, the recipient underwent a another debridement surgery.The recipient is being monitored.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly underwent the original debridement surgery on (b)(6) 2018, followed by another on (b)(6) 2018.The final debridement surgery occurred on (b)(6) 2018.The recipient's wound and lock issues have both resolved.This is the final report.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection reportedly resolved.This is the final report.
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Manufacturer Narrative
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The recipient's wound was reportedly managed medically until (b)(6) 2018.On (b)(6) 2018, the recipient's device was reportedly explanted due to wound breakdown, device extrusion, and an infection.The recipient was not reimplanted.The external visual inspection revealed the electrode was severed along the lead 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 an electrical test from being completed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.
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Search Alerts/Recalls
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