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

Model Number ABI24M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 23, 2017.

Event Description

Per the clinic, the patient experienced a dislodged internal magnet during an mri (tesla 1.5).It was reported that the patient's head was not wrapped per the manufacturers specifications for use with mri.Revision surgery is planned; however, yet to occur as of the date of this report.

• Brand Name: NUCLEUS 24 ABI
• Type of Device: NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109, ; 94286555
• MDR Report Key: 6269192
• MDR Text Key: 65453057
• Report Number: 6000034-2017-00147
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ABI24M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Date Manufacturer Received: 01/09/2017
• 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