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

Model Number CI-1601-05

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Failure of Implant (1924)

Event Date 07/01/2022

Event Type  Injury  

Event Description

The recipient reportedly experienced a skin dehiscence at the implant site.On (b)(6) 2022, the recipient underwent skin and muscle flap surgery.The recipient was given stitches and medication (type unknown) but the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

The recipient's device was explanted.The recipient has reportedly healed.The recipient will not be reimplanted at this time.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

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 external visual inspection revealed sliced silicone overmold on the top cover, as well as a severed electrode.These anomalies are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented and electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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¿ 3D ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: jennifer rhudy ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 14917697
• MDR Text Key: 295266342
• Report Number: 3006556115-2022-01113
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878008
• UDI-Public: (01)07630016878008(11)210629(17)240630
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR