Model Number CI-1400-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Necrosis (1971); Staphylococcus Aureus (2058); Pressure Sores (2326)
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Event Date 07/16/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing a staphylococcus aureus and proteus mirabilis infection at the magnet site.The recipient is presenting with pressure ulcers and skin necrosis at the right of the implant site.The cause of the pressure ulcers is unknown.The recipient's device was explanted.The recipient will not be reimplanted at this time.The recipient is healing.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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Manufacturer Narrative
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Additional information: the recipient's infection has resolved.No further medical intervention was needed.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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