Model Number SONATA |
Device Problem
Output Problem (3005)
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Patient Problems
Head Injury (1879); Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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The device has been explanted and has been returned to innsbruck where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
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Event Description
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According to the clinic there was a trauma following a domestic violence incident which has been reported to the authorities.The user was re-implanted.
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Manufacturer Narrative
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Conclusion: the investigation results revealed overload fractures in the active electrode confirming that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.
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Event Description
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According to the clinic there was a trauma following a domestic violence incident.The recipient no longer had any access to sound.The user was re-implanted.
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Search Alerts/Recalls
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