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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In situ measurements from (b)(6) 2017 showed a malfunctional device.Former measurements from may showed a functional device.No specific trauma has been reported.Re-implantation is considered.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.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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In (b)(4)2017 in situ measurements showed all channels with high impedance or involved in short circuits; former measurements from may showed a functional device.External parts have been checked no problems have been reported.No specific trauma has been reported.Re-implantation is considered but no date for surgery has been received.
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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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In (b)(6) 2017 in situ measurements showed all channels with high impedance or involved in short circuits; former measurements from may showed a functional device.External parts have been checked no problems have been reported.No specific trauma has been reported.The recipient was re-implanted.
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Search Alerts/Recalls
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