Model Number SONATA |
Device Problems
Impedance Problem (2950); Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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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 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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Family referred inconsistent responses, sometimes the patient responded better to auditory stimulus, sometimes no responses at all.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.However to confirm an exact root cause of failure a device investigation of the explanted device is necessary.No date for revision surgery has been communicated yet.
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Event Description
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The user's hearing performance with the device is affected.Re-implantation has been recommend, though has not been decided upon yet.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.
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Event Description
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The recipient's hearing performance with the device is affected.The recipient has been re-implanted.
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Manufacturer Narrative
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Conclusion: overload fractures in the active electrode which are consistent with an external mechanical impact were determined to be the root cause of device failure.The active electrode also showed some additional damage to the electrode wires, as being caused by minute device mobility.An accident or impact might have weakened the fixation of the implant, consequently leading to electrode mobility.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's hearing performance with the device is affected.The recipient has been re-implanted.
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Search Alerts/Recalls
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