Model Number AB-5100H-11A |
Device Problems
Insufficient Information (3190); Intermittent Communication Failure (4038)
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Patient Problems
Hearing Impairment (1881); Muscle Spasm(s) (1966); Discomfort (2330)
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Event Date 09/29/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing no loudness growth, eye twitching, physical discomfort, and decreased performance.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was re-implanted 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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The recipient's device was reportedly lost and will not return to advanced bionics for analysis.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.A review of the device history record was completed and no anomalies were noted.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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