MAUDE Adverse Event Report: COCHLEAR LTD BATTERY CHARGER (BLACK); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number Z341685

Device Problem Sparking (2595)

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

Event Type  Injury  

Event Description

It was reported that the patient experienced sparking charger while the device was in use (date not reported).A replacement equipment was sent to the patient.

• Brand Name: BATTERY CHARGER (BLACK)
• 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: 16143910
• MDR Text Key: 307152191
• Report Number: 6000034-2023-00220
• 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: 01/12/2023,12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Z341685
• Device Catalogue Number: Z341685
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2023
• Distributor Facility Aware Date: 12/27/2022
• Event Location: Home
• Date Report to Manufacturer: 12/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female