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

Model Number CI-1601-05

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Balance Problems (4401)

Event Type  Injury  

Event Description

The recipient reportedly experienced pain at the implant site with and without device use.The recipient is presenting with balance issues that do not seem to be device related and retention issues.The recipient was prescribed gabapentin and has recently been reduced from 900 mg to 200 mg.The recipient's pain has subsided.The recipient is in the process of healing.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient is also reportedly experiencing retention issues.Several options to help the recipient's issues have been offered, however, the recipient is non-compliant and has declined these options.The recipient is an inconsistent user.Additional treatment details will not be provided.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: 12321649
• MDR Text Key: 266562226
• Report Number: 3006556115-2021-01144
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)190425(17)220430
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: CI-1601-05
• 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