MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI612

Device Problems Positioning Failure (1158); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 3, 2022.

Event Description

Per the surgeon, the device was incorrectly initially positioned and was returned to theatre to re-implant the device on the same day.

• Brand Name: NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 14582453
• MDR Text Key: 293268762
• Report Number: 6000034-2022-01608
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)210805(17)230804
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2022,05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2023
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2022
• Distributor Facility Aware Date: 05/12/2022
• Date Report to Manufacturer: 05/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female