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	06/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient could not receive auditory sensation with the device.The patient underwent a revision surgery on (b)(6) 2021, in order to reposition the device.The implanted device remains.

• 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
• MDR Report Key: 12305671
• Report Number: 6000034-2021-02604
• Device Sequence Number: 14648908
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)200813(17)220812
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2021
• Report Date (Section F): 08/11/2021

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: 08/12/2022
• Device Model Number: ABI541
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2021
• Date Report to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2021
• 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: 13 YR
• Date Report Sent to FDA: 08/11/2021