MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-04

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 11/24/2020

Event Type  Injury  

Event Description

The recipient is reportedly experiencing retention issues.The recipient is presenting with inflammation and skin flap thickness.The recipient is being given a steroid regimen.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's issues reportedly resolved.The recipient continues to use the device.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 ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 11024361
• MDR Text Key: 221991796
• Report Number: 3006556115-2020-01521
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016877995
• UDI-Public: (01)07630016877995(11)200821(17)230831
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: CI-1601-04
• 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
• Patient Age: 68 YR