Model Number CI422 |
Device Problems
Circuit Failure (1089); Electrical Shorting (2926)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is submitted on september 21, 2023.
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Event Description
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Per the clinic, open circuits were noted on 2 electrodes and short circuits were noted on all electrodes.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.
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Manufacturer Narrative
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Per the clinic, the device was explanted on (b)(6) 2023, and the patient was reimplanted with another cochlear device during the same surgery.This report is submitted on january 10, 2024.
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Manufacturer Narrative
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Device analysis indicated device failure.Device analysis report is attached.This report is submitted on april 15, 2024.
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Search Alerts/Recalls
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