Model Number CI-1500-01 |
Device Problems
Electrical /Electronic Property Problem (1198); Output Problem (3005); Intermittent Communication Failure (4038)
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Patient Problems
Head Injury (1879); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/30/2022 |
Event Type
malfunction
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Event Description
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The recipient is experiencing loss of sound after a head trauma.Device testing could not be completed due to loss of lock.
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Manufacturer Narrative
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The recipient did not receive any medical intervention.The recipient ceased device use prior to the head trauma incident.A ct scan confirmed correct device location.Revision surgery will be 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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Corrections: sections b.1, b.2, & h.1 additional information: section d.6b advanced bionics considers the investigation into this reportable event as closed.The recipient is believed to have experienced a failure in-situ.A review of the device history record was completed and no anomalies were noted.The recipient remains implanted, however, ceased device use.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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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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage was observed on the top and bottom cover of the device.This is believed to have occurred during revision surgery.In addition, this inspection revealed a dented bottom cover.The photographic imaging inspection revealed dislodged electrical components within the hybrid.System lock could not be obtained at any spacing.The no lock condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The reported complaint of loss of sound with the device was verified during this analysis.The device was received with dislodged electrical components, which is consistent with the trauma reported.A corrective action was implemented.This older device configuration is not currently manufactured.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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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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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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