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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The hearing performance of the patient with the device is affected.No trauma or accident has been reported.External parts have been checked.Re-implantation considered.
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Manufacturer Narrative
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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.Re-implantation is being considered, but no surgery date has been communicated.
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Event Description
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The hearing performance of the patient with the device is affected.No trauma or accident has been reported.Re-implantation is considered but no date has been scheduled yet.
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Manufacturer Narrative
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Damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.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 hearing performance of the patient with the device is affected.No trauma or accident has been reported.The user has been re-implanted on (b)(6)2018.
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Search Alerts/Recalls
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