MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545); Implant Pain (4561); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 2, 2021.

Event Description

Per the clinic, the patient experienced pain, swelling, inflammation, and infection at the incision site, and was treated with antibiotics (specific type and duration not reported).The implanted device remains.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2021 and it is unknown if there are plans to re-implant the patient as of the date of this report.This report is submitted on december 09, 2021.

Manufacturer Narrative

Device analysis report attached.This report is submitted on january 11, 2022.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR 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: debbie ang ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12257569
• MDR Text Key: 264462909
• Report Number: 6000034-2021-02274
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)210222(17)230221
• 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,Followup
• Report Date: 12/23/2021

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: 02/21/2023
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 11/17/2021; 12/23/2021
• Supplement Dates FDA Received: 12/08/2021; 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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: Male