Model Number CI512 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Code Available (3191)
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Event Date 03/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report is submitted on april 14, 2020.
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Event Description
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Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.
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Manufacturer Narrative
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This report is submitted on 26 oct 2020.
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Manufacturer Narrative
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It was reported that the device was explanted on (b)(6) 2020 due to extrusion of the device.The patient was re-implanted with a new device during the same surgery.This report is submitted on 30 september 2020.
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Search Alerts/Recalls
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