MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT

Model Number CI-1500-04

Device Problem Unintended Movement (3026)

Patient Problems Edema (1820); Pain (1994); Swelling (2091)

Event Date 04/16/2020

Event Type  malfunction  

Event Description

The recipient¿s magnet has reportedly become displaced after undergoing an mri procedure using the antenna coil cover and approved bandaging protocol.The recipient reportedly experienced severe pain prior to and during the mri procedure and is now unable to use their external equipment due to swelling.Surgery to replace the internal magnet occurred on (b)(6) 2020.The recipient's pain and edema have resolved.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly resumed device use.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9991733
• MDR Text Key: 189721519
• Report Number: 3006556115-2020-00287
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016832185
• UDI-Public: (01)07630016832185(11)160713(17)190531
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR