Model Number CI-1500-02H |
Device Problems
Electrical /Electronic Property Problem (1198); Device Slipped (1584)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing no lock.External equipment was exchanged, however, the issue did not resolve.
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Manufacturer Narrative
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Revision surgery is reportedly scheduled.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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The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.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: section d.9.Programming adjustments were also made prior to revision, however, the issue did not resolve.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 external visual inspection revealed cuts in the silastic overmold on the top and bottom covers.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained intermittently.The device passed some of the electrical tests performed.The device passed mechanical tests performed.The reported complaint of no lock was confirmed during the analysis of this device.Elevated resistance was measured across an electrical component (kovar tab), which is believed to be related to the loss of lock.A corrective action was implemented.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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