MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI24R (CS)
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on august 30, 2021.
Event or Problem Description
Per the clinic, the device was explanted on (b)(6) 2021, due to extrusion of the electrode out into the external auditory canal.The patient was reimplanted with a new device during the same surgery.
Additional Manufacturer Narrative
Device analysis report is attached.This report is submitted on september 25, 2021.

• Brand Name: NUCLEUS 24 CONTOUR
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 12381639
• Report Number: 6000034-2021-02563
• Device Sequence Number: 3738356
• Product Code: MCM
• UDI-Device Identifier: 09321502002349
• UDI-Public: (01)09321502002349(11)080617(17)100616
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 06/16/2010
• Device Model Number: CI24R (CS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/29/2021
• Supplement Report FDA Received Date: 09/25/2021
• 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
• Patient Age: 14 YR