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

Model Number CI-1601-04

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing retention issues due to skin flap thickness.Adjustments were made, however, the issue did not resolve.Revision surgery is being considered.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.External equipment was exchanged and the recipient's issue resolved.The recipient is using 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: 11009082
• MDR Text Key: 222027097
• Report Number: 3006556115-2020-01504
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)181024(17)211031
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• 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