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

Model Number CI24R (ST )

Device Problem Device Issue (2379)

Patient Problem No Code Available (3191)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed march 9, 2016.Device not received by manufacturer.

Event Description

Per the clinic, the device was explanted (date not reported) due to a device problem.It is unknown whether the patient was reimplanted with a new device, as of the date of this report.

Manufacturer Narrative

Per the clinic, the device was expanted on (b)(6) 2016 and the patient was reimplanted with another cochlear device during the same surgery.

• 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 Contact: pavana nayak ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 5488174
• MDR Text Key: 39926115
• Report Number: 6000034-2016-00610
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (ST )
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• 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: 49 YR