MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (CS)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Scar Tissue (2060)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 9, 2019.

Event Description

Per the clinic, the patient experienced keloid scarring at the abutment site that was treated with a steroid injection.The implant remains in-situ.

Manufacturer Narrative

Additional information reported to cochlear by recipient's clinic: the surgery to remove keloids was occurred on (b)(6) 2019.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8770359
• MDR Text Key: 150360481
• Report Number: 6000034-2019-01146
• Device Sequence Number: 1
• Product Code: MCM
• 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
• Report Date: 07/29/2019,07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CS)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2019
• Distributor Facility Aware Date: 07/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR