Model Number SONATA |
Device Problems
Device Operates Differently Than Expected (2913); Mechanics Altered (2984)
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Patient Problems
Failure of Implant (1924); No Information (3190)
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Event Date 03/11/2015 |
Event Type
Injury
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Event Description
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It was reported that the patient doesn't respond to voices and sounds as before.An accident to trauma is unknown.
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Manufacturer Narrative
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(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Manufacturer Narrative
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Additional information: according to currently available information, it appears that the problems with the active electrode are most likely broken wires due to an accident.To determine an exact root cause a device investigation of the explanted device is necessary.If and when the patient is explanted, the complaint will be reopened.
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Event Description
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It was reported that the patient doesn't respond to voices and sounds as before.An accident tor trauma is unknown.
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Manufacturer Narrative
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Conclusion: damage to the active electrode likely caused by minute device mobility was determined to have led to device failure over time.Additionally, a few overload fractures were found which are most likely due to an impact to the implant site, this might have adversely affected the fixation of the device.The investigation results appear to match the problems mentioned in the patient report.This is a final report.
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Event Description
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It was reported that the patient doesn't respond to voices and sounds as before.An accident tor trauma is unknown.The patient has been re-implanted.
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Search Alerts/Recalls
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