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

Model Number	ABI24M
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on may 16, 2019, by cochlear limited on behalf of (b)(4).Exemption number e2016011.
Event or Problem Description
Per the audiologist, the patient experienced a performance decrement and subsequent loss of connection to the internal device.Reprogramming attempts were made; however, this did not resolve the issue.Reimplantation has been scheduled; however, this has not occurred as of the date of this report.
Additional Manufacturer Narrative
Per the clinic, the device was explanted on (b)(6) 2019 and the recipient was reimplanted with a new device during the same surgery.This report is filed on august 28, 2019.

• Brand Name: NUCLEUS 24 ABI
• Common Device Name: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8614131
• Report Number: 6000034-2019-00871
• Device Sequence Number: 14083979
• Product Code: MHE
• UDI-Device Identifier: 09321502002325
• UDI-Public: (01)09321502002325(11)140925(17)160924
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/24/2016
• Device Model Number: ABI24M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/31/2019
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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: 6 YR