Model Number CI24RE (ST) |
Device Problems
No Device Output (1435); Electrical Shorting (2926)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on june 04, 2021.
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Event Description
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Per the clinic, open and short circuits were noted on multiple electrodes.Reprogramming attempts were made; however, the issue could not be resolved.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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Analysis of the returned device indicates device failure.Device analysis report is attached.This report is submitted on september 14, 2021.
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Manufacturer Narrative
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Per the clinic, the device was explanted on (b)(6) 2021.This report is submitted on july 15, 2021.
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Search Alerts/Recalls
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