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

Model Number CI-1601-04

Device Problems Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 04/14/2022

Event Type  Injury  

Event Description

The recipient reportedly experienced pain, non auditory sensations, and decreased performance.The recipients device was explanted to control allergies and was swabbed for infection.The recipient was not reimplanted at this time.

Manufacturer Narrative

The recipient's pain was reportedly not resolved with surgery.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient reportedly had a bacteriological analysis that confirmed a germ.The recipient's pain reportedly increased after the bacteriological analysis.The recipient reportedly had an mri that confirmed an atypical lesion.Test's are being performed to determine the origin of the lesion.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient is reportedly experiencing an infection on the auditory nerve.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient will not be re-implanted.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 root cause cannot be determined as it could involve: recipient anatomy/ hygiene, cochlear environment, surgical technique, trauma to the recipient, etc.Advanced bionics cannot obtain anymore information due to patient privacy laws.The external visual inspection revealed cuts in the silicone overmold on the top cover, as well as a severed electrode.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented an 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: 14270050
• MDR Text Key: 290657901
• Report Number: 3006556115-2022-00641
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878039
• UDI-Public: (01)07630016878039(11)210405(17)240331
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• 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: 37 YR
• Patient Sex: Female