MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 03, 2017.

Event Description

Per the clinic, the patient experienced episodes of neck, shoulder pain with device use and pain at the implant site.Subsequently, the patient was prescribed a steroid (date not reported) which resulted in reduction of the pain at the implant site.

• Brand Name: NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 94286555
• MDR Report Key: 6375326
• MDR Text Key: 68962950
• Report Number: 6000034-2017-00469
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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 Expiration Date: 07/24/2019
• Device Model Number: CI422
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• 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