MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (CA)

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Head Injury (1879)

Event Date 11/16/2022

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a magnet dislodgement subsequent to sustaining a head trauma.There are plans to replace the magnet; however, this has not occurred as of the date of this report.

Event Description

Per the clinic, the surgery to replace the magnet was completed on (b)(6) 2022.The implanted device remains.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 15786497
• MDR Text Key: 303565157
• Report Number: 6000034-2022-03576
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2022,12/05/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2022
• Distributor Facility Aware Date: 12/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female