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

Model Number CP1000

Device Problem Crack (1135)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Per the clinic, the patient reportedly experienced a burn at the back of the ear due to a cracked battery.

• 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: 12237226
• MDR Text Key: 263814470
• Report Number: 6000034-2021-02271
• 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
• Type of Report: Initial
• Report Date: 07/28/2021,07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2021
• Distributor Facility Aware Date: 07/08/2021
• Date Report to Manufacturer: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention