Model Number SONATA |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/27/2023 |
Event Type
malfunction
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Event Description
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The recipient attended for a regular follow-up session, where affected channels were seen during in situ testing.Further proceedings are currently unknown.
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Manufacturer Narrative
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Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.No information on possible further steps has been received.
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Event Description
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The recipient attended for a regular follow-up session, where affected channels were seen during in situ testing.Further proceedings are currently unknown.
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Search Alerts/Recalls
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