MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Breakdown (2681); Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an mrsa infection at implant site (specific date not reported) due to extrusion of the electrode, exposing the receiver/stimulator.Subsequently, the patient was treated with oral and topical antibiotics (specific date and duration not reported).There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on march 10, 2022.

Manufacturer Narrative

The device was explanted on (b)(6) 2022.There are no plans to re-implant the patient with another device.This report is submitted on may 3, 2022.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, nsw 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; no. 8 jalan kerinchi,; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 13717500
• MDR Text Key: 286911397
• Report Number: 6000034-2022-00632
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)211005(17)231004
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

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 Expiration Date: 10/04/2023
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female