Model Number CI24RE (L24) |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on june 30, 2021.
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Event Description
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Per the clinic, the device was explanted on (b)(6) 2021, due to improper placement of the electrode array.The patient was reimplanted with a new device on the same date.
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Manufacturer Narrative
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The device analysis report is attached.This report is submitted on july 21, 2021.
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Search Alerts/Recalls
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