Model Number CI-1400-01 |
Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2022 |
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 company was informed that the recipient was explanted due to non-use.The recipient was not reimplanted.The explanted device will not be returned to the company for analysis.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly healed.A review of the device history record was completed and no anomalies were noted.No further details will be provided.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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