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

Model Number OSI200

Device Problem Expulsion (2933)

Patient Problem Skin Disorders (4543)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 12, 2020.

Event Description

Per the clinic, the patient experienced skin issues resulting in extrusion of the device.The patient was placed under general anesthesia on (b)(6) 2020, in order to explant the device.The patient has not been reimplanted with a new device as of this report.

Event Description

It was reported that the patient underwent skin revision surgery, and was administered oral and topical antibiotics for the infection.The implanted device remains.

Manufacturer Narrative

It was reported the device was explanted due to infection.This report is submitted on 9 march 2021.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10660162
• MDR Text Key: 211018472
• Report Number: 6000034-2020-02783
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)200617(17)220616
• 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: 02/12/2021

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 Expiration Date: 06/16/2022
• Device Model Number: OSI200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/11/2020
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR