MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (CS)

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced infection at the implant site.Subsequently, the device was explanted on (b)(6) 2023.Reimplantation 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

Device analysis report attached.This report is submitted on july 12, 2023.

Manufacturer Narrative

Per the clinic, the patient experienced a skin flap necrosis and an extrusion of the receiver/stimulator (specific date not reported).This report is submitted on september 13, 2023.

• Brand Name: NUCLEUS 24 CONTOUR
• 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: kalai tamilselvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17303788
• MDR Text Key: 318822974
• Report Number: 6000034-2023-02202
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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