MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 05, 2022.

Event Description

Per the clinic, the patient underwent an mri on (b)(6) 2020 and experienced pain and chronic dermatitis after the mri.The patient was hospitalized on (b)(6) 2022 due to infection at the implant site.Subsequently, the patient was treated with oral and iv antibiotics (specific date and duration not reported) during hospitalization.The patient was discharged on (b)(6) 2022 and was prescribed with oral and topical antibiotics (specific date and duration not reported).Surgery to replace the implant magnet is planned but had not taken place at the time 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 experienced a skin flap necrosis.Additional information has been requested but it has not been made available as of the date of this report.This report is submitted on may 31, 2023.

Manufacturer Narrative

Correction: the patient was treated with topical steroid and oral antibiotics after discharging from hospital, not topical and oral antibiotics as previously reported.Additional info: the implant magnet was replaced on (b)(6) 2023.This report is submitted on june 27, 2023.

• Brand Name: NUCLEUS CI512 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: 15541600
• MDR Text Key: 301151413
• Report Number: 6000034-2022-02931
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)171005(17)191004
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2023

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: 10/04/2019
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 09/20/2023; 06/02/2023
• Supplement Dates FDA Received: 05/31/2023; 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• 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 Age: 53 YR
• Patient Sex: Female