MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT; NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM

Model Number	ABI541
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the device was electively explanted on december 08, 2025, due to mri is needed for other health issue.There are no plans to re-implant the patient with a new device as of the date of this report.

• Brand Name: NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
• Common Device Name: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 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: nurshahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24033885
• Report Number: 6000034-2026-00233
• Device Sequence Number: 15768233
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)160223(17)180222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P000015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 02/22/2018
• Device Model Number: ABI541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male