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

Model Number CI24RE (L24)

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

This report filed (b)(6) 2016.

Event Description

Per the clinic, the device was explanted for an unspecified medical reason on (b)(6) 2016.The patient was reimplanted with a new cochlear device during the same surgery.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is filed march 18, 2016.

• Brand Name: NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM
• Type of Device: PGQ
• Manufacturer (Section D): COCHLEAR LTD.; 14 mars rd; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 5420599
• MDR Text Key: 37836036
• Report Number: 6000034-2016-00369
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

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: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• 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
• Patient Age: 52 YR