Model Number MI1000 MED-EL CONCERT PIN |
Device Problem
Device Appears to Trigger Rejection (1524)
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Patient Problems
Tissue Damage (2104); Tissue Breakdown (2681)
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Event Date 01/21/2020 |
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 integrity of the skin has broken down.A skin rupture has formed in the area of the implant.The implant housing is visible from the outside.The size of the gap is growing every day and reportedly the skin is thinning from pressure.Imaging shows the implant housing to be located behind the pinna where the hole is.
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Manufacturer Narrative
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Conclusion: device investigations did not reveal any device defect or problem.This finding was expected, because according to the recipient report the device was explanted for medical reasons, namely a skin breakdown at the implant site caused by repeated traumas.As a consequence infection was seen at the implant site and the implant housing was seen to be exposed through the skin.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of the infection.Mechanical damages found during investigation are related to the removal surgery.This is a final report.
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Event Description
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The implant housing is extruding through the skin.The issues first started in summer of 2019.The user sustained an impact to the head afterwards the user had a short-term edema and slow migration of the device housing closer to the ear was observed.Reportedly the skin was thinning from pressure and dissected after a second impact was sustained.An infection was present, dissection progressed, and the device extruded.The user_s hearing performance with the device was not affected.The user has been explanted on (b)(6), 2020.The infection cleared after explantation.
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Search Alerts/Recalls
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