Model Number MI1250 SYNCHRONY 2 |
Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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The device has been explanted and 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 device is thought to have migrated post-operatively.A post-operative scan performed on the (b)(6) 2020 showed incomplete insertion with only 4 electrodes within the cochlea.The user was successfully re-implanted on the (b)(6) 2020.
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Manufacturer Narrative
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Additional information: according to the received information from the field, the active electrode array migrated almost completely out of cochlea post-operatively.Reportedly, multiple insertion attempts were made at implantaton and during re-insertion surgery the electrode was inadvertently damaged, thus affected channels were seen and re-implantation with a new device was carried out at a later point in time.The explanted device has not been received for investigation yet.
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Event Description
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The recipient was implanted on the (b)(6) 2020.At implantation there were multiple attempts to insert via round window, then a cochleostomy was drilled and widened and the electrode was inserted.The device is thought to have migrated post-operatively.At a re-positioning surgery the array was reportedly damaged.The recipient was re-implanted with a new device on the (b)(6) 2020.Despite requested, the explanted device has not been not received for investigation.
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Search Alerts/Recalls
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