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

Model Number CI632

Device Problems Device Appears to Trigger Rejection (1524); Appropriate Term/Code Not Available (3191)

Patient Problems Post Operative Wound Infection (2446); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 3, 2021.

Event Description

Per the clinic, the patient developed an infection at the incision site.The implanted device remains.There are plans for the patient to undergo a revision surgery, however; this has yet to occur as of the date of this report.

Manufacturer Narrative

Per the clinic, it was reported that there was no infection.However, the patient experienced an extrusion of the implanted device.This report is submitted on september 03, 2021.

Manufacturer Narrative

Per the clinic, the recipient underwent a revision surgery on (b)(6) 2021.The implanted device remains.This report is submitted on august 20, 2021.

• 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
• MDR Report Key: 12264514
• MDR Text Key: 264693467
• Report Number: 6000034-2021-02308
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)201215(17)221214
• 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,Followup
• Report Date: 08/12/2021

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: 12/14/2022
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/03/2021; 08/12/2021
• Supplement Dates FDA Received: 08/20/2021; 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention