Model Number CI612 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on february 24, 2023.
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Event Description
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Per the clinic, the patient experienced poor sound quality with the internal device.Troubleshooting and reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2023 and the patient was implanted with a new device during the same surgery.
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Manufacturer Narrative
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This report is submitted on april 11, 2023.
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Search Alerts/Recalls
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