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

Model Number CI-1500-01

Device Problems No Audible Prompt/Feedback (2282); Intermittent Communication Failure (4038)

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

Event Date 06/29/2021

Event Type  malfunction  

Event Description

The recipient reportedly experienced loss of lock and no sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

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 tool damage and delamination of the silicone overmold on the top and bottom covers.This is believed to have occurred during revision surgery.Photographic imaging inspection revealed disturbed wire bonds at the digital and analog chip.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed an electrical test performed.The device passed the mechanical tests performed.The internal visual inspection confirmed disturbed wirebonds at the digital and analog chips.The failure of this device is attributed to multiple shorted wirebonds at the digital and analog chips, which prevented the device from achieving lock.A corrective action was implemented.In addition, this device had nitrogen that exceeded the test limits.Based on an assessment of the helium leak test data, it is determined that this device was non-hermetic, and that the root cause of the excessive nitrogen was a leak through the feedthru seals.Due to the presence of moisture getter, no signs of moisture were observed.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

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool damage and delamination of the silicone overmold on the top and bottom covers.This is believed to have occurred during revision surgery.Photographic imaging inspection revealed disturbed wire bonds at the digital and analog chip.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed an electrical test performed.The device passed the mechanical tests performed.The internal visual inspection confirmed disturbed wirebonds at the digital and analog chips.The failure of this device is attributed to multiple shorted wirebonds at the digital and analog chips, which prevented the device from achieving lock.A corrective action was implemented.In addition, this device had nitrogen that exceeded the test limits.Based on an assessment of the helium leak test data, it is determined that this device was non-hermetic, and that the root cause of the excessive nitrogen was a leak through the feed thru seals.Due to the presence of moisture getter, no signs of moisture were observed.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 90K¿ ADVANTAGE 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: 12218557
• MDR Text Key: 265277679
• Report Number: 3006556115-2021-01022
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)170413(17)190331
• Combination Product (y/n): N
• Reporter Country Code: AG
• 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: 06/30/2021

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: 03/31/2019
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/13/2021; 10/18/2021; 04/27/2022; 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2017
• 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: 7 YR
• Patient Sex: Female