MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (L24)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 23, 2020.

Event Description

Per the clinic, i twas reported that the patient experienced a loss of residual hearing, resulting in a decrease of benefit with device use.Subsequently, the device was explanted on (b)(6) 2020, and the patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on september 11, 2020.

• Brand Name: NUCLEUS HYBRID L24
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10311911
• MDR Text Key: 199977484
• Report Number: 6000034-2020-01905
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)180109(17)200108
• Combination Product (y/n): N
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2020
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR