Model Number CI22M |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report is submitted on 29 september 2020.
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Event Description
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Per the clinic, the patient experienced a performance decrement with device use resulting in explant of the device on (b)(6) 2020.The patient was re-implanted 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 13, 2020.
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Search Alerts/Recalls
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