Model Number MI1000 MED-EL CONCERT PIN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932)
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Event Date 10/25/2019 |
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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Since implantation, the patient hasn't shown any clear advancements with the device.On (b)(6) 2019, a small bump was seen over her scar.According to ent, a tumor at the region was found with 8mm in diameter with no inflammation processes.It is painful on palpation.The user refuses to use the device.No incident of accident or trauma was reported.
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Manufacturer Narrative
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Conclusion: according to the information received from the field the recipient experienced pain when using the audioprocessor caused by tumoration which developed at the implant site.A revision surgery was performed.It was noticed that part of the flap suture was accidentally left in place for a prolonged period of time after implantation surgery, leading to an inflammatory reaction in response to the retained material that is also known as suture granuloma.Although the latter may mimic a tumor, it represents a benign formation.Non-absorbable sutures should be removed within 1-2 weeks of their placement.Such prompt removal reduces the risk of suture infection and tissue reaction.Reportedly the recipient is doing fine after revision surgery.The device remains implanted and in use.This is a final report.
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Event Description
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Since implantation, the recipient hadn't showed any clear advancement with the device.There was no clear response to the device according to rehabilitation information.On (b)(6)2019 a small bump was seen over her scar.The recipient underwent a revision surgery on (b)(6) 2019.Reportedly, the recipient was re-activated with good results.
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Search Alerts/Recalls
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