Model Number CI632 |
Device Problem
Device Tipped Over (2589)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on 05 may 2021.
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Event Description
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Per the clinic, the device was explanted on (b)(6) 2021 due to tip fold-over of the electrode array.The patient was re-implanted with a new device during the same surgery.
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Manufacturer Narrative
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Device analysis report attached.This report is submitted on september 2, 2021.
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Search Alerts/Recalls
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