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

Model Number	CI24R(ST)
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient experienced poor performance and pain with the device.Troubleshooting attempts were made; however, the issue could not be resolved.The device was explanted (b)(6) 2024, and the patient was reimplanted with another cochlear device during the same surgery.
Additional Manufacturer Narrative
This report is submitted on april 04, 2024.
Additional Manufacturer Narrative
Device analysis indicated device failure.Device analysis report.

• Brand Name: NUCLEUS 24K
• 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: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19039456
• Report Number: 6000034-2024-01216
• Device Sequence Number: 8471584
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332(11)080806(17)100805
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2024
• 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): 07/30/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/05/2021
• Device Model Number: CI24R(ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2008
• 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 Age: 17 YR
• Patient Sex: Female