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

Model Number	CI24R(ST)
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced middle ear infection causing perforation of the eardrum which led to the extrusion of the electrodes.The patient was treated with topical antibiotics (specific date and duration not reported).However, the issue could not be resolved and subsequently the device was explanted on (b)(6) 2021.The patient was reimplanted with another cochlear device during the same surgery.
Additional Manufacturer Narrative
This report is submitted on november 23, 2021.
Additional Manufacturer Narrative
Device analysis report attached.This report is submitted on april 30, 2024.

• Brand Name: NUCLEUS 24K
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: dzafira dzul 'karnain ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12859116
• Report Number: 6000034-2021-03589
• Device Sequence Number: 11914397
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332(11)080904(17)100903
• 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: 2009
• 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): 04/12/2024

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: 09/03/2010
• Device Model Number: CI24R(ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female