MAUDE Adverse Event Report: COCHLEAR LTD CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI1000

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on sept 16, 2022.

Event Description

It was reported that the rechargeable battery of the sound processor was found to have allegedly leaked fluid.Replacement equipment was sent, and no reports of patient injury are associated with this event.

• Brand Name: CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED
• 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: 15433803
• MDR Text Key: 300034359
• Report Number: 6000034-2022-02766
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/25/2022
• Date Report to Manufacturer: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male