MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM; MHE

Model Number CI8+1M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the device was electively explanted on (b)(6) 2016 due to non-use.There are no plans to re-implant the patient with a new device.

Manufacturer Narrative

This report is submitted january 13, 2017.

• Brand Name: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
• Type of Device: MHE
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6136955
• MDR Text Key: 61186480
• Report Number: 6000034-2016-02398
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI8+1M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• 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: 37 YR