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 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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One month ago (approximately (b)(6) 2022) the parents of the user noticed a reduced hearing and poor speech understanding and sent the external parts to the clinic for troubleshooting.Further technical checks and medical intervention is scheduled but no date has been provided yet.
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Manufacturer Narrative
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Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.The recipient has been re-implanted but the explanted device has not been received for investigation yet.
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Event Description
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One month ago (approximately (b)(6) 2022) the parents of the user noticed a reduced hearing and poor speech understanding with the device.The user has been re-implanted.
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Manufacturer Narrative
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Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.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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One month ago (approximately (b)(6) 2022) the parents of the user noticed a reduced hearing and poor speech understanding with the device.The user has been re-implanted.
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Search Alerts/Recalls
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