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

Model Number OSI200

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Tissue Breakdown (2681); Insufficient Information (4580)

Event Date 09/28/2022

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2022 due to other medical reason.It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Per the clinic, it was reported that the patient experienced skin breakdown (date not reported).Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Per the clinic, the patient experienced a skin necrosis (specific date not reported) and was treated with oral antibiotics and topical ointment (specific date and duration not reported).

Event Description

Per the clinic, the patient experienced an infection at the site of breakdown (specific date not reported).

• 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
• MDR Report Key: 15725606
• MDR Text Key: 303026542
• Report Number: 6000034-2022-03268
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2023,04/26/2023

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: 06/03/2023
• Device Model Number: OSI200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2023
• Distributor Facility Aware Date: 04/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/25/2023; 03/06/2023; 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female