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

Model Number CI632

Device Problem Expulsion (2933)

Patient Problems Tissue Breakdown (2681); Drug Resistant Bacterial Infection (4553); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 21, 2023.

Event Description

Per the clinic, it was reported that the receiver/stimulator had extruded (date not reported).Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient experienced an mrsa infection at the implant site.The cultures returned positive for the infection.On (b)(6), 2023, the patient was placed on a 30 days course of iv and oral antibiotics.The implanted device remains.Additional information has been requested but it has not been made available as of the date of this report.This report is submitted on (b)(6), 2023.

Event Description

Per the clinic, the patient experienced an mrsa infection at the implant site.The cultures returned positive for the infection.On (b)(6) 2023, the patient was placed on a 30 days course of iv and oral antibiotics.The implanted device remains.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

Correction: the previous follow-up mdr report #1 submitted as 6000034-2023-02640 on september 04, 2023 was filed inadvertently.Per the clinic, the patient experienced skin breakdown at the implant site and underwent a surgical procedure (date not reported) in order to drain the site.The patient was also prescribed oral steroids (specific date and duration not reported).The patient was hospitalized (date not reported) and the device was explanted on (b)(6) 2023.This report is submitted on november 06, 2023.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17581566
• MDR Text Key: 321512512
• Report Number: 6000034-2023-02640
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)230201(17)250131
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 09/04/2023,08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2023
• Distributor Facility Aware Date: 08/09/2023
• Date Report to Manufacturer: 08/09/2023
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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