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

Model Number CI24M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2010

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 23, 2021.

Event Description

Per the clinic, the device was explanted on (b)(6) 2010 (reason unknown).The patient was reimplanted with a new device.Further information is being sought from the clinic.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 13068768
• MDR Text Key: 282699364
• Report Number: 6000034-2021-04077
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• 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