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

Model Number CP900 ACC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

This report is filed april 12, 2016.The device is currently unavailable.

Event Description

It was reported, the battery holder "burns" the recipient.Additional information has been requested but has not been made available as of the date of this report, april 12, 2016.

Manufacturer Narrative

The returned device was carefully analysed, however, the reported problem could not be reproduced during the analysis process.The device passed all of the functional, electrical and the thermal monitoring tests performed at the externals device analysis laboratory.Note that the recipient's battery module, batteries, coil and coil cable were not returned with the device.This report is filed (b)(6) 2016, by (b)(4).

• 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: bianca hanlon ; 1 university avenue; macquarie university, nsw, CO 2109 ; AS 2109 ; 3037909010
• MDR Report Key: 5571207
• MDR Text Key: 42447672
• Report Number: 6000034-2016-00723
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP900 ACC
• Device Catalogue Number: Z339275
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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