Model Number CI632 |
Device Problem
Migration (4003)
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Patient Problem
Deafness (1801)
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Event Date 11/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on december 18, 2019.
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Event Description
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Per the clinic, the patient experienced no response on activation.The device was explanted (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.
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Manufacturer Narrative
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It was reported that the patient's device had extruded prior to explant.This report is submitted 8 january 2020.
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Manufacturer Narrative
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This report is filed on february 20, 2020.
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Event Description
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The device was explanted due to misplaced electrode array and non-auditory percepts.The device passed all electrical tests confirming correct device function.
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Search Alerts/Recalls
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