MAUDE Adverse Event Report: COCHLEAR LTD CP1000 PROCESSING UNIT PACKED, BROWN; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Eczema (4547)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 31, 2024.

Event Description

Per the clinic, the patient developed eczema at the implant site and subsequently was treated with a combination of topical steroid and antibiotics on (b)(6) 2023, for 14 days, however, the issue could not be resolved and clinical management of the patient is ongoing.

• Brand Name: CP1000 PROCESSING UNIT PACKED, BROWN
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kohilah nadaraja ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18611282
• MDR Text Key: 334138295
• Report Number: 6000034-2024-00509
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Device Catalogue Number: Z482006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male