MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24K; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI24R (ST)
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted february 6, 2019.
Event or Problem Description
Per the clinic, the device was explanted (date not reported) due to extrusion of the electrode lead into the external auditory canal.The patient was contralaterally reimplanted with a new device during the same surgery.

• Brand Name: NUCLEUS 24K
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8308720
• Report Number: 6000034-2019-00132
• Device Sequence Number: 11088766
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332(11)121204(17)141203
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/03/2014
• Device Model Number: CI24R (ST)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention