Model Number CI532 |
Device Problem
Positioning Failure (1158)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on december 30, 2021.
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Event Description
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Per the clinic, the patient experienced poor performance with the device and the tip of the electrode array was found to be folded over in the cochlea, resulting in the decision to explant the device.The device was explanted on (b)(6) 2021 and the patient was reimplanted with another cochlear device during the same surgery.
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Manufacturer Narrative
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Device analysis report is attached.This report is submitted on january 24, 2022.
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Search Alerts/Recalls
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