MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Skin Erosion (2075); Skin Infection (4544)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 1, 2022.

Event Description

Per the surgeon, the patient experienced an abscess over the internal magnet with discharging pus, skin breakdown and cellulitis of the right pinna.The device was explanted on (b)(6) 2022.It is unknown if there are plans to re-implant the patient with another device.

Manufacturer Narrative

Per the clinic, the patient was treated with iv antibiotics (specific date and duration not reported).This report is submitted on april 08, 2022.

Manufacturer Narrative

Per the clinic, the patient was hospitalized (specific date not reported).Device analysis report attached.This report is submitted on june 07, 2022.

• Brand Name: NUCLEUS CI422 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kalai tamilselvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13625998
• MDR Text Key: 286321462
• Report Number: 6000034-2022-00543
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025706
• UDI-Public: (01)09321502025706(11)141106(17)161105
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2016
• Device Model Number: CI422
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male