Model Number CI512 |
Device Problem
No Device Output (1435)
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Patient Problem
Death (1802)
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Event Date 04/27/2015 |
Event Type
malfunction
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Event Description
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Per the clinic, the patient experienced a loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.
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Manufacturer Narrative
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(b)(4).The implanted device remains.
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Manufacturer Narrative
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Per the clinic, the device was explanted (b)(6) 2015, and the patient was reimplanted with a new device during the same surgery.This report is filed (b)(6) 2015.
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Search Alerts/Recalls
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