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

Model Number	OSI200
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Headache (1880); Skin Burning Sensation (4540); Implant Pain (4561)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced headaches and pain around the implant coil site with and without device use since initial implantation on (b)(6) 2022.The patient was then prescribed with pain medications which helps with the symptoms.The patient also experienced a heating sensation with the device use, which improved after switching to a lower strength external magnet.However, the pain around the implant site recurred which leads to the decision to explant the device.The device was explanted on (b)(6) 2026.During the procedure, the surgeon reported that the transcutaneous implant is loose and that there was no torque at all.It is unknown if there are plans to reimplant the patient 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.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Common Device Name: COCHLEAR¿ OSIA¿ SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 25242399
• Report Number: 6000034-2026-01864
• Device Sequence Number: 21488543
• Product Code: PFO
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)220208(17)240207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2026
• Report Date (Section F): 05/21/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/07/2024
• Device Model Number: OSI200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/21/2026