MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 ABI; NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM

Model Number ABI24M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2023

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2023, due to unspecific medical reasons.There are no plans to re-implant the patient with a new device as of the date of this report.

• Brand Name: NUCLEUS 24 ABI
• Type of Device: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 17858199
• MDR Text Key: 324763946
• Report Number: 6000034-2023-03172
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2023,09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ABI24M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2023
• Distributor Facility Aware Date: 09/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male