MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM

Model Number CP900SERIES STANDARD RECHARGEABLE BATTERY

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on november 21, 2016 by cochlear limited on behalf of cochlear americas.(b)(4).The battery is currently unavailable.

Event Description

Per the clinic, the disposable battery of the sound processor was found to have leaked fluid.Replacement equipment was sent, and no reports of patient injury are associated with this event.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial, co 80111
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6115941
• MDR Text Key: 60421070
• Report Number: 6000034-2016-02262
• 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
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900SERIES STANDARD RECHARGEABLE BATTERY
• Device Catalogue Number: Z285986
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/02/2016
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/20/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention