Model Number SONATA |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it is to 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 (b)(6) 2017 the patient was found with a malfunctional device.No specific trauma has been reported.Re-implantation is considered.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is being considered, but no surgery date has been communicated.
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Event Description
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In (b)(6)2017 the recipient's device was found to be malfunctioning.No specific trauma has been reported.Re-implantation is considered.
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Manufacturer Narrative
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Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The problems given in the recipient report appear to match the damage found.This is a final report.
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Event Description
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In (b)(4) 2017 the recipient's device was found to be malfunctioning.No specific trauma has been reported.The user has been re-implanted.
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Search Alerts/Recalls
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