Model Number CI24R (CS) |
Device Problems
Expulsion (2933); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on august 21, 2020.
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Event Description
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Per the surgeon, the patient experienced an extrusion of the electrode array from the cochlea, due to a cholesteatoma in the middle ear.The device was explanted on (b)(6) 2020.It is unknown whether there are plans to reimplant to the patient with a new device, as of the date of this report.
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Manufacturer Narrative
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Correction: the previous or initial mdr submitted on august 21, 2020 was filed inadvertently.No device extrusion has occurred.Device analysis report attached.This report is submitted on december 1, 2023.
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Search Alerts/Recalls
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