MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 22 mar 2021.

Event Description

Per the clinic, the device was explanted on (b)(6) 2021 due to incorrect placement of electrode.The patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted on 26 may 2021.

• Brand Name: NUCLEUS CI632 PROFILE PLUS 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: 11537173
• MDR Text Key: 241390062
• Report Number: 6000034-2021-00847
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)200109(17)220108
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2022
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR