Model Number MI1250 SYNCHRONY 2 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/07/2022 |
Event Type
malfunction
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Event Description
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The user had an accident and the hearing performance with the device is affected.The user was explanted.
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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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Manufacturer Narrative
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Conclusion: according to the information received from the field the electrode array was accidentally pulled out of cochlea by the recipient.Device investigation revealed damage to the active electrode due to device minute mobility, possibly following the unintentional active electrode misplacement.Reportedly the recipient is handicapped and was manipulating the device in the middle ear with a sharp instrument, which might have contributed to the observed damages.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
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Event Description
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The user had an accident and the hearing performance with the device is affected.As per additional information, it is thought that the user opened the sutured auditory canal and penetrated a sharp object into the middle ear.When the object was further extended the entire electrode was pulled out of the cochlea through the skin suture into the external auditory canal.It is thought that this happened somewhere between the (b)(6) 2022 and the (b)(6) 2022.The device was explanted.The user won't be re-implanted, as further automanipulative behavior cannot be excluded.
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Search Alerts/Recalls
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