MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ 90K IMPLANT; COCHLEAR IMPLANT

Model Number CI-1400-01

Device Problems Mechanical Problem (1384); No Audible Prompt/Feedback (2282); Output Problem (3005); Intermittent Communication Failure (4038)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing intermittent lock.The recipient is presenting with loss of sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Device testing revealed abnormal results.Revision surgery is scheduled.

Manufacturer Narrative

The recipient is now reportedly experiencing no lock.Additional external equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Device testing could not be completed due to loss of lock.Revision surgery is scheduled.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 tool damage to the top cover, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The electrode condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.This device had moisture that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis data, it is determined that this device was non-hermetic.Corrective actions were implemented.This version of the 90k 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.

Manufacturer Narrative

The recipient's device was 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.

• Brand Name: HIRES¿ 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: heidi white ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 13010616
• MDR Text Key: 284109332
• Report Number: 3006556115-2021-01886
• Device Sequence Number: 1
• Product Code: MCM
• 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,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2006
• Device Model Number: CI-1400-01
• 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: 06/07/2004
• 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: 19 YR
• Patient Sex: Female