MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 29, 2020.

Event Description

Per the clinic, the patient experienced infection at implant site and subsequent extrusion of the internal magnet through the skinflap.Revision surgery has been scheduled to replace the magnet and repair the flap.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10603838
• MDR Text Key: 209144072
• Report Number: 6000034-2020-02597
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502009317
• UDI-Public: (01)09321502009317
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• 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