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

Model Number CI-1600-05

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing decreased performance.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient's device was reportedly explanted.The recipient was reimplanted with another cochlear device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's device is reportedly lost and will not return to advanced bionics for analysis.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 explanted device is presumed lost and will not return for analysis.A review of the device history record was completed and rework was performed in the electrode area near the fantail.This rework is not believed to be related to the adverse event.No further 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 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: 10960558
• MDR Text Key: 220647348
• Report Number: 3006556115-2020-01513
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016855696
• UDI-Public: (01)07630016855696(11)190823(17)220731
• 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: Consumer,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/05/2021; 10/02/2021; 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• 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: 45 YR
• Patient Sex: Female