Model Number MI1200 SYNCHRONY |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Undesired Nerve Stimulation (1980); Injury (2348); No Information (3190)
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Event Date 01/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 recipient was bilaterally implanted on (b)(6) 2019.Post-operatively he has been found to have a facial nerve injury for the right side.He is planned to undergo an exploration with possible nerve repair in (b)(6) 2019.The clinic is planning to remove the device and replace it during the surgery.
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Manufacturer Narrative
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Med-el elektromedizinische geraete gmbh and vibrant med-el submit mdr reports on behalf of med-el corporation (exemption number e2015033).Conclusion: according to the received information from the field, the recipient suffered from a facial nerve paralysis after implantation; facial nerve injury is a known possible surgical complication of cochlear implantation.A revision surgery was carried out to repair the facial nerve, but the partial facial paralysis is reportedly still present afterwards.Also, during this procedure the electrode array was accidentally pulled out of cochlea and re-inserted straight again.Despite the facial nerve issue, the recipient is hearing and progressing well and the device remains implanted and in use.This is a final report.
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Event Description
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The recipient was bilaterally implanted on (b)(6) 2019.Post-operatively a facial nerve injury has been found for the right side.An exploratory surgery to repair the facial nerve was performed in february 2019.The symptoms relating to facial nerve injury are still present after the revision surgery.As per audiologist, recipient still has observable partial facial paralysis.Device has been activated and recipient is hearing and progressing well.Audiologist confirmed that recipient appears to receive sound percepts along the whole array.
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Search Alerts/Recalls
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