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

Model Number OSI200

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 28, 2023.

Event Description

Per the clinic, the patient experienced soft tissue breakdown and wound dehiscence at implant site, exposing the implant (specific date not reported).The patient underwent a revision surgery to clean the wound on (b)(6) 2023.The patient also developed an infection at implant site and subsequently was treated with topical antibiotics for seven days (specific date reported), however, the issue did not resolve.There are plans to explant the device; however, this has not occurred as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2024 under general anesthesia.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.This report is submitted on march 08, 2024.

Manufacturer Narrative

Device analysis report attached.This report is submitted on april 05, 2024.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• 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 LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18415994
• MDR Text Key: 331576266
• Report Number: 6000034-2023-04136
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)210528(17)230527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2023
• Device Model Number: OSI200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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 Sex: Male