Model Number CI512 |
Device Problem
No Device Output (1435)
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Patient Problems
Hearing Loss (1882); Failure of Implant (1924)
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Event Date 12/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This report is submitted on december 30, 2019.
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Event Description
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Per the clinic, the patient experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.
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Manufacturer Narrative
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This report is submitted on april 17, 2020.
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Manufacturer Narrative
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It was reported that the device was explanted on (b)(6) 2020 and the patient was re-implanted with a new device during the same surgery.This report is submitted 12 february 2020.
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Search Alerts/Recalls
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