MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS® HYBRID S12; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (S12)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Impairment (1881)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 3, 2020.

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 (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

• Brand Name: NUCLEUS® HYBRID S12
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9542240
• MDR Text Key: 173448841
• Report Number: 6000034-2020-00051
• Device Sequence Number: 1
• Product Code: PGQ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2020,12/12/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (S12)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2020
• Date Report to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR