MAUDE Adverse Event Report: COCHLEAR LTD 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 Problem Necrosis (1971)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin necrosis (eschar) at the incision site.Subsequently, the patient was treated with oral and topical antibiotics (specific date and duration not reported).Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Per the clinic, the device was explanted (date not reported).It is unknown if there are plans to reimplant the patient as of the date of this report.

Event Description

Per the clinic, the patient experienced an extrusion of receiver/stimulator (specific date not reported).Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 17467869
• MDR Text Key: 320471629
• Report Number: 6000034-2023-02511
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)230509(17)250508
• 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,Followup
• Report Date: 09/19/2023,09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2023
• Distributor Facility Aware Date: 09/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention