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

Model Number CI-1400-02H

Device Problem Positioning Problem (3009)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

The recipient is reportedly experiencing a displaced magnet.The recipient is presenting with soreness and a wound at the implant site.The recipient was advised to cease device use for three to four weeks.The recipient is in the process of healing.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.External equipment was exchanged and the issues reportedly resolved.The recipient has resumed device use.The recipient will be monitored per center protocol.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 IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10636357
• MDR Text Key: 210185709
• Report Number: 3006556115-2020-01093
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2009
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention