MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 22; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an extrusion of the receiver/stimulator at the magnet site (specific date not reported).Explantation is planned but has not taken place at the time of this report.Additional information has been requested but has not been made available as of the date of this report.

Event Description

Per the clinic, the patient experienced wound dehiscence (specific date not reported).The patient underwent a skin revision surgery on (b)(6) 2022, in order to close the skin.The device was explanted on (b)(6) 2022.Reimplantation is planned but had not taken place at the time of this report.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 16059122
• MDR Text Key: 306236040
• Report Number: 6000034-2022-03879
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2023,12/30/2022

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 Model Number: CI22M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2023
• Distributor Facility Aware Date: 12/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male