Model Number SONATA |
Device Problems
Device Operates Differently Than Expected (2913); Output Problem (3005)
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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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Patient's hearing with the device is affected.Parents reported that a head trauma had occurred.Re-implantation is considered.
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Manufacturer Narrative
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According to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.An impact is mentioned in the patient report, however to confirm an exact root cause of failure a device investigation of the explanted device is necessary.Additionally, two electrode channels were already in status hi prior to the reported impact.Re-implantation is being considered but no date has been scheduled.
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Event Description
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Recipients_ hearing with the device is affected after a head trauma.Re-implantation is considered.
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Manufacturer Narrative
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Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was 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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Recipient's hearing with the device is affected after a head trauma.The recipient has been re-implanted.
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Search Alerts/Recalls
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