Model Number CI22M |
Device Problem
No Device Output (1435)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on 1 october 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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It has now been reported that the device was explanted on (b)(6) 2020.The patient was reimplanted with a new device during the same surgery.This report is submitted on december 10, 2020.
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Event Description
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It has now been reported that the device was explanted on (b)(6) 2020.The patient was reimplanted with a new device during the same surgery.
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Search Alerts/Recalls
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