Model Number CI-1601-05 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Date 10/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient is using the device.This is the final report.
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Event Description
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The recipient has atypical anatomy which presented difficulty during initial electrode array insertion and intraoperative cerebrospinal fluid leak (csf).No additional medical intervention was required during the recipient's post-operation recovery following implantation.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.This is the final report.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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