MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS HYBRID L24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI24RE (L24)
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient sustained a head trauma due to an accident (specific date not reported) leading to a loss of implant function.Subsequently, the device was explanted on (b)(6) 2025, and the patient was reimplanted with another cochlear device within the same surgery.
Additional Manufacturer Narrative
Based on clinical symptoms and troubleshooting performed (date not reported) it was determined that the results are consistent with a device malfunction.
Additional Manufacturer Narrative
The previous or initial mdr submitted on july 03, 2025, was filed inadvertently.No device failure occurred.

• Brand Name: NUCLEUS HYBRID L24
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: shalini rajandran krishnan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 21590637
• Report Number: 6000034-2025-00877
• Device Sequence Number: 15684637
• Product Code: MCM
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)160712(17)180711
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/11/2018
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 07/23/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 07/03/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2016
• 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 Age: 72 YR
• Patient Sex: Male