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

Model Number CP1000

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 7 february 2020.

Event Description

It was reported that the rechargeable battery malfunctioned and reportedly "melted" (date not reported).There was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.

• Brand Name: CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (SAND)
• 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: 9679137
• MDR Text Key: 178094883
• Report Number: 6000034-2020-00315
• 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: 02/07/2020,01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/07/2020
• Distributor Facility Aware Date: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention