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 Necrosis (1971); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 28, 2021.

Event Description

Per the clinic, the patient experienced a skin flap necrosis and infection at the implant site.The patient was treated with topical antibiotics (date and duration not reported); however, the issue did not resolve.The device was explanted on (b)(6) 2021, and reimplantation is planned but has not taken place as of the date of this report.

Manufacturer Narrative

Correction: the initial mdr submitted on december 28, 2021 was filed inadvertently.No topical antibiotics were prescribed.Device analysis report attached.This report is submitted on february 14, 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: aini yusof ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13091403
• MDR Text Key: 282804354
• Report Number: 6000034-2021-03963
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)210304(17)230303
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/21/2022

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: 03/03/2023
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• 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: Female