Model Number CI512 |
Device Problem
No Device Output (1435)
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Patient Problem
No Code Available (3191)
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Event Date 07/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on august 21, 2020.
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Event Description
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Per the clinic, the patient experienced a loss of connection to the internal device; the issue could not be resolved.The implanted device remains.Explant and reimplantation is planned but has not taken place at the time of this report.
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Manufacturer Narrative
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It was reported that the device was explanted on (b)(6) 2020.The patient was re-implanted with another device during the same surgery.This report is submitted on 2 november 2020.
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Search Alerts/Recalls
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