MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Per the clinic, the patient reportedly experienced a burn at implant site following an mri (1.5 tesla).The clinician has made attempts to resolve the issue by pulling new skin over the implant magnet, the patient was also treated with iv antibiotics (date not reported).Prior to the patient undergoing the mri, it was reported that the patient had a history of skin issues at the implant site.

• Brand Name: NUCLEUS CI512 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: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109, ; 94286555
• MDR Report Key: 6434912
• MDR Text Key: 70856336
• Report Number: 6000034-2017-00590
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)100115(17)120115
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2012
• Device Model Number: CI512
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention