MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problems Head Injury (1879); Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin breakdown at the implant site and infection subsequent to sustaining a head trauma.The device was explanted (date not reported) and it is unknown if there are plans to reimplant the patient as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Event Description

Per the clinic, the patient also experienced an extrusion at the receiver/stimulator site.It was confirmed that the device was explanted on (b)(6) 2023.

Event Description

Per the clinic, the patient was placed under general anesthesia on (b)(6) 2023, in order to undergo a skin flap rotation revision surgery.The patient was also treated with topical antibiotics and iv antibiotics (specific date and duration not reported).

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT 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: 18370318
• MDR Text Key: 331046628
• Report Number: 6000034-2023-04078
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)210626(17)230625
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2024,02/13/2024

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: 06/25/2023
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2024
• Distributor Facility Aware Date: 02/13/2024
• Date Report to Manufacturer: 02/13/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/16/2024; 03/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male