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

Model Number CI612

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

Patient Problems Abscess (1690); Head Injury (1879); Laceration(s) (1946); Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 17, 2023.

Event Description

Per the clinic, the patient experienced an mrsa infection at implant site.Subsequently, the device was explanted on (b)(6) 2022.It is unknown if there are plans to reimplant the patient as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient was hospitalized due to abscess at the implant site caused by a laceration sustained from a fall a month prior.Abscess was confirmed via ct scan.The patient underwent bed side incision and drainage on (b)(6) 2022, and was treated with iv antibiotics (duration not reported).The device was then explanted due to mrsa infection and exposure of the receiver/stimulator the receiver/stimulator.This report is submitted on february 14, 2023.

• Brand Name: NUCLEUS CI612 COCHLEAR 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16180841
• MDR Text Key: 307463243
• Report Number: 6000034-2023-00201
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)220608(17)240607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female