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Model Number CI-1601-05 |
Device Problems
Output below Specifications (3004); Migration (4003)
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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 Type
Injury
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Event Description
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The recipient is reportedly experiencing decreased performance.Device testing revealed results within normal limits.Programming adjustments were made, however, the issue did not resolve.Revision surgery is under consideration.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient will not pursue revision surgery at this time and will be managed by programming adjustments.The recipient continues to use the device.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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