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

Model Number CI632

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 4, 2021.

Event Description

Per the clinic, the patient experienced an infection and wound dehiscence at the incision site, and an extrusion of the receiver/stimulator, on (b)(6) 2021.Revision surgery was performed on (b)(6) 2021, to close the incision; however, the issue could not be resolved, and the wound reopened on (b)(6) 2021.The device was explanted on (b)(6) 2021.The patient has not been reimplanted with a new device as of the date of this report.

Manufacturer Narrative

This report is submitted on june 29, 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: 11767884
• MDR Text Key: 248749644
• Report Number: 6000034-2021-01190
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)200903(17)220902
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/02/2022
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR