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

Model Number Z285983

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Type  Injury  

Manufacturer Narrative

The reported problem in this complaint has been resolved by means of external equipment exchange.As per new international air transport association (iata) regulations (iata dangerous goods regulations (dgr) for lithium batteries in 2017) and the enforcement from our shipping vendors, we will no longer be able to receive back cochlear rechargeable batteries.The return of this battery is not expected due to these regulations, therefore an investigation will not be conducted.This report is submitted on august 14, 2019 by cochlear limited.

Event Description

It was reported that cp900 rechargeable battery was leaking and will not work.The reported problem in this complaint has been resolved by means of external equipment exchange.

• Brand Name: CP900 SERIES STANDARD RECHARGEABLE BATTERY MODULE (CARBON)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8891516
• MDR Text Key: 154257981
• Report Number: 6000034-2019-01575
• 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: 08/14/2019,07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Z285983
• Device Catalogue Number: Z285983
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2019
• Distributor Facility Aware Date: 07/23/2019
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention