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

Model Number	ABI541
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced minimal to absent auditory perception and non-auditory stimulation such as shocking sensation, dizziness and nausea, during implant reactivation.Reprogramming attempts were made; however, the issue could not be resolved resulting in the decision to explant the device.The device was explanted on (b)(6) 2026.It is unknown if there are plans to reimplant the patient as of the date of this report.
Additional Manufacturer Narrative
Device analysis report attached.

• Brand Name: NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
• Common Device Name: NUCLEUS AUDITORY BRAINSTEM 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: hema dewi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25076128
• Report Number: 6000034-2026-01611
• Device Sequence Number: 10425815
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)241018(17)261017
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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 Model Number: ABI541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: 42 YR
• Patient Sex: Male