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

Model Number CP900

Device Problems Sparking (2595); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6) 2022.

Event Description

It was reported that the patient experienced a shocking sensation from a sparking charger cord while the device was in use (date not reported).Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: BATTERY CHARGING KIT (BLACK)
• 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 avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 14651478
• MDR Text Key: 293956098
• Report Number: 6000034-2022-01696
• 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
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP900
• Device Catalogue Number: Z342011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female