Model Number CI622 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on september 18, 2020.
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Event Description
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Per the clinic, the tip of the electrode array was partially inserted and found to be folded over in the cochlea, resulting in the decision to explant the device.The device was explanted (b)(6) 2020, and the patient was reimplanted with a new device during the same surgery.
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Manufacturer Narrative
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The device analysis report is attached.This report is submitted on november 20, 2020.
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Search Alerts/Recalls
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