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

Model Number CI24R(CA)

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 02, 2024.

Event Description

Per the clinic, the patient experienced pain at the implant site.Subsequently, the patient underwent a revision surgery on (b)(3) 2023 in order to resect the pain nerve covering the implant site.

Manufacturer Narrative

Correction: the initial mdr submitted on january 2, 2024 was filed inadvertently.No revision surgery or serious injury has occurred.This report is submitted on february 5, 2024.

• Brand Name: NUCLEUS 24 CONTOUR ADVANCE
• 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: mastura ruhanet ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18423524
• MDR Text Key: 331788456
• Report Number: 6000034-2024-00019
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R(CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 18 YR
• Patient Sex: Male