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

Model Number CI622

Device Problem Expulsion (2933)

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 17, 2023.

Event Description

Per the clinic, the device was explanted on (b)(6) 2023, due to an extrusion of the receiver/stimulator and electrode array.The patient was also treated with antibiotics (specific type, date and duration not reported) due to an abscess at the implant site.It is unknown if there are plans to reimplant the patient as of the date of this report and additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

Correction: the correct date of this report (b4) and date received by manufacturer is august 11, 2023 ; not july 28, 2023 as previously reported.The information regarding the initial reporter has also been updated.This report is submitted on september 04, 2023.

Manufacturer Narrative

Per the clinic, the patient was hospitalized for iv antibiotics administration (specific date not reported).This report is submitted on october 31, 2023.

• 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: nabila zahari ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17561573
• MDR Text Key: 321308057
• Report Number: 6000034-2023-02821
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)230110(17)250109
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• 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
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2023
• 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 Sex: Female