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

Model Number ABI 24M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 31, 2021.

Event Description

Per the clinic, the patient experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted (date unknown).It is unknown if there are plans to re-implant the patient with another device.

Manufacturer Narrative

Analysis of the device on return to cochlear was a device failure.The device analysis report is attached.This report is submitted on september 28, 2021.

• 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: 11905897
• MDR Text Key: 253508488
• Report Number: 6000034-2021-01584
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ABI 24M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention