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 Date 08/24/2020 |
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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During a review mapping appointment on (b)(6) 2020 channels with high impedance were found.The parents did not report a decline in hearing performance with the device.
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Event Description
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During a review mapping appointment on (b)(6) 2020 channels with high impedance were found.The parents did not report a decline in hearing performance with the device.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.Further monitoring and measurements are planned.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause 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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During a review mapping appointment on (b)(6) 2020 channels with high impedance were found.The parents did not report a decline in hearing performance with the device.The user was 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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During a review mapping appointment on (b)(6) 2020 channels with high impedance were found.The parents did not report a decline in hearing performance with the device.The user was re-implanted.
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Search Alerts/Recalls
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