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

Model Number CP1000 MAGNET

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Erythema (1840); Necrosis (1971); Pain (1994); Skin Erosion (2075)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced pain and redness at magnet site caused by the external magnet being too strong.This resulted in the development of a sore (initially thought to be a necrosis) at the implant site which was treated with a topical antibiotic and stopping use of the device until the area healed.The magnet was changed from a 2 to a ½ strength.The implant remains in-situ.

Manufacturer Narrative

This report is submitted on jun 1, 2023.

• Brand Name: CP1000 MAGNET
• 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: 17035574
• MDR Text Key: 316278098
• Report Number: 6000034-2023-01723
• 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: 06/01/2023,05/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000 MAGNET
• 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: 06/01/2023
• Distributor Facility Aware Date: 05/13/2023
• Date Report to Manufacturer: 05/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female