Model Number CI512 |
Device Problems
Failure to Deliver Shock/Stimulation (1133); Failure to Read Input Signal (1581); Intermittent Shock/Stimulation (2287)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on dec 28, 2023.
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Event Description
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Per the clinic, the patient experienced intermittencies and subsequent loss of sound and connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.
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Manufacturer Narrative
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Per the clinic, it was reported that the device was explanted on (b)(6) 2024.The patient was reimplanted with another cochlear device during the same surgery.This report is submitted on may 09, 2024.
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Search Alerts/Recalls
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