Model Number MI1200 SYNCHRONY PIN |
Device Problem
Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/01/2020 |
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 user noticed the device has not been working as well in the last few months compared to before.
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Event Description
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The user noticed the device has not been working as well in the last few months compared to before.The user will be re-implanted but no date has been set yet.
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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.In addition information on the implant registration card states that two channels were left outside of cochlea at implantation surgery.Further two additional channels were disabled due to a postoperative migration out of cochlea.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is planned but no date has been scheduled yet.
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Event Description
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The user noticed the device has not been working as well in the last few months compared to before.The user was re-implanted with a shorter electrode variant.
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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.In addition information on the implant registration card states that two channels were left outside of cochlea at implantation surgery.Further two additional channels were disabled due to a postoperative migration out of cochlea.The problems given in the recipient report appear to match the damage found.This is a final report.
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Search Alerts/Recalls
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