MAUDE Adverse Event Report: COCHLEAR LTD. CP800 SERIES STANDARD RECHARGEABLE BATTERY MODULE (BLACK); NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

Model Number CP800 ACCESSORIES

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Battery not returned to manufacturer.

Event Description

It was reported that the rechargeable battery of the sound processor was found to have leaked fluid.Replacement equipment was sent to the patient, and no reports of patient injury are associated with this event.

• Brand Name: CP800 SERIES STANDARD RECHARGEABLE BATTERY MODULE (BLACK)
• Type of Device: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial CO 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6094912
• MDR Text Key: 59725075
• Report Number: 6000034-2016-02229
• 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: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP800 ACCESSORIES
• Device Catalogue Number: N/A
• Device Lot Number: 15045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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