Model Number SONATA |
Device Problems
Device Operates Differently Than Expected (2913); Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/20/2017 |
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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The patient suffers from inconsistent responses to sound.No trauma has been reported, no redness, swelling or pain could be observed.
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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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The recipient has inconsistent responses to sound.No trauma has been reported; no redness, swelling or pain could be observed.Re-implantation is being considered but a date for surgery has not been scheduled.
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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.The device was explanted, but has not been received for investigation yet.
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Event Description
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The recipient has inconsistent responses to sound.No trauma has been reported; no redness, swelling or pain could be observed.The user has been re-implanted.
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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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The recipient has inconsistent responses to sound.No trauma has been reported; no redness, swelling or pain could be observed.The user has been re-implanted.
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Search Alerts/Recalls
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