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

Model Number CI532

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 17, 2020.

Event Description

Per the clinic, the patient experienced no clinical benefit with device use due to anatomical issues.The device was explanted on (b)(6) 2020.

Manufacturer Narrative

This report is submitted on 9 february 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: 10849426
• MDR Text Key: 216563945
• Report Number: 6000034-2020-03151
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)180605(17)200604
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2020
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 MO