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

Model Number ABI24M

Device Problem No Device Output (1435)

Patient Problem Hearing Impairment (1881)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

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
• Type of Device: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8614131
• MDR Text Key: 145223773
• Report Number: 6000034-2019-00871
• Device Sequence Number: 1
• Product Code: MHE
• UDI-Device Identifier: 09321502002325
• UDI-Public: (01)09321502002325(11)140925(17)160924
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR