MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI532

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

Patient Problem Swelling (2091)

Event Date 08/27/2019

Event Type  Injury  

Event Description

Per the clinic, the patient presented to clinic with swelling and redness to the implant site.It was reported by the patient that the site was bumped, resulting in pain.Subsequently, the patient was treated with a ten day course of oral antibiotics, beginning (b)(6) 2019.The patient will continue routine clinical management.

Event Description

Per the clinic, it was reported that the swelling at the implant site was confirmed to be an infection.The infection has since resolved, following the previously reported antibiotic treatment.

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9016245
• MDR Text Key: 158768849
• Report Number: 6000034-2019-01857
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/10/2019,09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2021
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2019
• Distributor Facility Aware Date: 09/16/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR