Model Number CI624 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on october 20, 2020.
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Event Description
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Per the clinic, the device was explanted on (b)(6) 2020, due to poor performance with device use and improper placement of the electrode array.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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