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

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Impairment (1881)

Event Date 02/01/2022

Event Type  Death  

Manufacturer Narrative

This report is submitted on march 3, 2022.

Event Description

Per the clinic, the patient experienced intermittent connection with the implant.A skin flap revision was performed on (b)(6) 2022.

Manufacturer Narrative

Per the clinic, the patient was placed under general anesthesia (specific date not reported).The implanted device remains.This report is submitted on july 04, 2022.

• Brand Name: NUCLEUS FREEDOM 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 BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: kalai tamilselvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur,, wilayah persekutuan 59200-, ; MY 59200,
• MDR Report Key: 13691822
• MDR Text Key: 286740563
• Report Number: 6000034-2022-00801
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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 Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/4022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/04/2022
• 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: 57 YR
• Patient Sex: Male