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

Model Number OSI200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 29, 2023.

Event Description

Per the clinic, the device was explanted on (b)(6) 2023, due to skin erosion at the actuator site.There are no plans to re-implant the patient with another cochlear device as of the date of this report.

Manufacturer Narrative

Device analysis report attached.This report is submitted on (b)(6), 2023.

• 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: aini yusof ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17639104
• MDR Text Key: 322133663
• Report Number: 6000034-2023-02768
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)210222(17)230221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2023
• Device Model Number: OSI200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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: Female