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

Model Number CI24R (CS)

Device Problem No Apparent Adverse Event (3189)

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

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 18, 2022.

Event Description

Per the surgeon, the patient was electively explanted on october 28, 2022 (reason unknown).It is unknown if there are plans to re-implant the patient with another device.

• Brand Name: NUCLEUS 24 CONTOUR
• 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: 15821775
• MDR Text Key: 303895130
• Report Number: 6000034-2022-03439
• Device Sequence Number: 1
• Product Code: MCM
• 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: 11/18/2022,10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CS)
• 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: 11/18/2022
• Distributor Facility Aware Date: 10/27/2022
• Date Report to Manufacturer: 10/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female