Model Number CI24RE (ST) |
Device Problems
Output Problem (3005); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2020 |
Event Type
malfunction
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Event Description
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Per the clinic, the patient experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2023.The patient was re-implanted with a new device in the same procedure.
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Manufacturer Narrative
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This report is submitted on september 14, 2023.
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Manufacturer Narrative
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Device analysis indicated device failure.Device analysis report attached.This report is submitted on october 27, 2023.
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Search Alerts/Recalls
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