MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

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

Patient Problem Ulcer (2274)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an ulcer at the magnet site because of the magnet being too strong.Treatment of the ulcer is unknown.The implant remains in-situ.Further information is being sought from the clinic.

Manufacturer Narrative

This report is submitted on may 3, 2022.

Event Description

Correction: the initial mdr submitted on may 3, 2022 was filed inadvertently.No device malfunction/ explantation or serious injury has occurred.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT 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: 14275125
• MDR Text Key: 290697154
• Report Number: 6000034-2022-01228
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)200701(17)220630
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022,07/27/2022

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: 06/30/2022
• Device Model Number: CI622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2022
• Distributor Facility Aware Date: 07/27/2022
• Date Report to Manufacturer: 07/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female