Model Number MI1260 SONATA 2 |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/08/2024 |
Event Type
malfunction
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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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Event Description
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In situ testing showed affected channels.Re-implantation was recommended, however, not confirmed yet.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However, to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation has not been decided yet.
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Event Description
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In situ testing showed affected channels.The clinic is running pre-op studies to determine if they are going to re-implant.
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Search Alerts/Recalls
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