MAUDE Adverse Event Report: COCHLEAR LTD CP900 SERIES STANDARD RECHARGEABLE BATTERY MODULE (MOCHA); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900 ACC

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the rechargeable battery of the sound processor allegedly leaked fluid (date, and particulars of the alleged event or its circumstances were not reported).There was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.The rechargeable battery has not been returned to the manufacturer as of the date of this report.

• Brand Name: CP900 SERIES STANDARD RECHARGEABLE BATTERY MODULE (MOCHA)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9532926
• MDR Text Key: 173910960
• Report Number: 6000034-2019-03052
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/31/2019,11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900 ACC
• Device Catalogue Number: Z285986
• Device Lot Number: VAU0000639-330000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2019
• Distributor Facility Aware Date: 11/19/2019
• Event Location: Other
• Date Report to Manufacturer: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention