MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI532

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 10 dec 2020.

Event Description

Per the clinic, the patient experienced pain around the implant site and poor sound quality from the device.The device was explanted on (b)(6) 2020.

Manufacturer Narrative

This report is submitted on 10 march 2021.

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
• 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: 10981539
• MDR Text Key: 220633645
• Report Number: 6000034-2020-03394
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)190131(17)210130
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2021
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR