MAUDE Adverse Event Report: COCHLEAR LTD COCHLEAR OSIA OSI200 IMPLANT; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number OSI200

Device Problem Loss of Osseointegration (2408)

Patient Problem Implant Pain (4561)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 2, 2021.

Event Description

Per the clinic, the patient experienced pain at the implant site and a loss of osseointegration.The patient was placed under general anaesthesia on (b)(6) 2021, in order to explant the device.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on jul 13, 2021.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11396747
• MDR Text Key: 234205032
• Report Number: 6000034-2021-00530
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: K191921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2021
• Device Model Number: OSI200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR