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

Model Number CI-1601-04

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Skin Irritation (2076)

Event Type  Injury  

Event Description

The recipient is reportedly experiencing irritation and redness at the implant site.The recipient was prescribed anti-bacterial and anti-fungal cream.The recipient was recommended to cease device use.The recipient's implant site is healing.

Manufacturer Narrative

The recipient's irritation was reportedly being treated as an infection which seems to be cleared.The recipient was recommended to discontinue anti-fungal cream, reduce magnet strength, and use moleskin which helped with retention.

Manufacturer Narrative

The recipient is still experiencing redness and irritation with occasional pain at the implant site.The recipient's dermatologist prescribed a high potency steroid solution.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient will reportedly continue to be monitored.No further treatment details will 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: 9125248
• MDR Text Key: 162335224
• Report Number: 3006556115-2019-00577
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)190129(17)220131
• 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,Followup,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/05/2019; 12/10/2019; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention