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

Model Number CI-1600-04

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

Patient Problems Hearing Impairment (1881); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Event Description

The recipient is reportedly experiencing decreased performance, despite device testing within normal limits.Revision surgery is scheduled.

Manufacturer Narrative

The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.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 cuts in the silicone overmold on the top cover.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the hires ultra device is no longer distributed.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 IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey o'linn ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 16132550
• MDR Text Key: 307065436
• Report Number: 3006556115-2022-02267
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)171003(17)200930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: CI-1600-04
• 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: 10/03/2017
• 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 Age: 95 YR
• Patient Sex: Male