MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

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

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the recipient experienced issue with magnet retention.Ct scan revealed soft tissue swelling over the receiver stimulator site, no evidence of surrounding inflammation or abscess formation.No trauma reported.A steroid prescription was provided.The implanted device remains.

Manufacturer Narrative

Per the patient's surgeon, it was reported that the device was explanted on (b)(6) 2019.It is unknown if the patient was reimplanted, as of the date of this report.This report is submitted decmeber 19, 2019.

Manufacturer Narrative

This report is submitted on 26 march 2020.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE 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: 9068708
• MDR Text Key: 160511321
• Report Number: 6000034-2019-01852
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)100420(17)120419
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2019,03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2012
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2019
• Distributor Facility Aware Date: 09/04/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention