MAUDE Adverse Event Report: COCHLEAR LTD CP1150 SOUND PROCESSOR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1150

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on may 25, 2023.

Event Description

Per the clinic, the patient experienced a painful blister at the magnet site which was treated with oral and topical antibiotics.The implant remains in-situ.

• Brand Name: CP1150 SOUND PROCESSOR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 17000637
• MDR Text Key: 315906691
• Report Number: 6000034-2023-01603
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2023,04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP1150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2023
• Distributor Facility Aware Date: 04/05/2023
• Date Report to Manufacturer: 04/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female