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

Model Number CP1000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 30, 2022.

Event Description

It was reported that the disposable battery of the sound processor was found to have allegedly leaked fluid resulting in a burn to the ear (specific date not reported).Replacement equipment was sent to the patient.Additional information has been requested but it has not been made available as of the date of this report.

• 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: mastura ruhanet ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13946314
• MDR Text Key: 288165872
• Report Number: 6000034-2022-00921
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Device Catalogue Number: Z544551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2022
• 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): Other
• Patient Sex: Female