MAUDE Adverse Event Report: COCHLEAR LTD CP1000 PROCESSING; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number EAC200 SERIES POWER DOME

Device Problem Product Quality Problem (1506)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced pain from the ear mould and was prescribed antibiotic and steroid drops.The implant remains in-situ.

Manufacturer Narrative

This report was submitted on march 14, 2023.

• Brand Name: CP1000 PROCESSING
• 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 ave; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 16535121
• MDR Text Key: 311288196
• Report Number: 6000034-2023-00768
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EAC200 SERIES POWER DOME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female