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

Model Number CI24RE (L24)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Impairment (1881)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 31, 2019.

Event Description

Per the clinic, the patient experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted (b)(6) 2019.It is unknown if the patient has been re-implanted with another device.

Manufacturer Narrative

This report is submitted on 23 march 2020.

• Brand Name: NUCLEUS HYBRID L24
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9533682
• MDR Text Key: 173186812
• Report Number: 6000034-2019-02966
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)161108(17)181107
• Combination Product (y/n): N
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/31/2019,02/25/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2018
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2019
• Date Report to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR