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

Model Number CI512

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 22, 2022.

Event Description

Per the clinic, the patient experienced an infection, wound dehiscence and drainage at the implant site, exposing the receiver/stimulator (specific date not reported).Subsequently, the patient was treated with oral antibiotic for 10 days (specific date not reported) and topical antibiotics (specific date and duration not reported).There are plans to explant the device; however, this has not occurred as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, it was also reported that the patient experienced skin necrosis (date not reported).Subsequently, the device was explanted on (b)(6) 2022.It is unknown if there are plans to re-implant the patient as of the date of this report.Device analysis report attached.This report is submitted on december 14, 2022.

• 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: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15843605
• MDR Text Key: 304100211
• Report Number: 6000034-2022-03470
• Device Sequence Number: 1
• Product Code: MCM
• 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
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2012
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• 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