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

Model Number	CI24R(ST)
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	01/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is submitted on february 04, 2019.
Event or Problem Description
Per the clinic, the patient experienced a loss of connection to the internal device; however the issue could not be resolved.The implanted device remains.
Additional Manufacturer Narrative
Additional: it has since been reported that the device was electively explanted on (b)(6) 2019; the patient was re-implanted with a new device during the same surgery.This report is submitted on may 13, 2019.
Additional Manufacturer Narrative
This report is filed on june 28, 2019.

• 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: 8300617
• Report Number: 6000034-2019-00124
• Device Sequence Number: 1589555
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332(11)091026(17)111025
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/26/2009
• Device Model Number: CI24R(ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 01/19/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 06/04/2019
• Initial Report FDA Received Date: 02/03/2019
• Supplement Report FDA Received Date: 05/12/2019; 06/28/2019
• 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
• Patient Age: 12 YR