Model Number MI1000 MED-EL CONCERT |
Device Problem
Circuit Failure (1089)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/09/2024 |
Event Type
malfunction
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Event Description
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The user was involved in a car accident and suffered a major head trauma on the implanted side.Re-implantation is considered.
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it should 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 was involved in a car accident and suffered a major head trauma on the implanted side.Re-implantation is considered, but no date has been scheduled yet.
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Manufacturer Narrative
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Additional information: based on the information and measurements received, a mechanical damage of the stimulator electronics, which is typical for a severe external impact to the housing, appears likely.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
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Search Alerts/Recalls
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