Model Number CI-1400-02H |
Device Problems
Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/31/2022 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing device migration.The recipient is a non-user of the device.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient has healed following explant surgery.The surgeon reportedly used monopolar electrocautery during explant surgery.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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Advanced bionics considers the investigation into this reportable event as closed.The recipient was not re-implanted.The external visual inspection revealed sliced silicone overmold on the top and bottom covers, as well as a severed electrode.These anomalies are 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 performed.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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Search Alerts/Recalls
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