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

Model Number	ABI541
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced magnet dislodgement during an mri after the manufacturer's mri instructions for use (ifu) were not followed.The patient underwent the mri with the implant magnet still in place due to a misunderstanding regarding the use of a non-magnetic plug.A revision procedure was subsequently performed (date not reported) to remove the magnet bedside.At the time of reporting, the implanted device remained in situ, and the clinical team was evaluating whether to replace the magnet or use a non-magnetic plug.Additional information has been requested but has not been made available 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: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25662606
• Report Number: 6000034-2026-02273
• Device Sequence Number: 12161620
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)260204(17)280203
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P000015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/30/2026

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2026
• 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 Sex: Male