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

Model Number CI-1400-01

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing sound quality issues.External equipment was exchanged and programming adjustments were made, however the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

The external visual inspection revealed a severed array as well as a cut antenna shield wire.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device failed the electrical tests performed.This is an interim report.

Manufacturer Narrative

The recipient 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.

Manufacturer Narrative

The external visual inspection revealed a severed array as well as a damaged antenna coil and shield wires.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection confirmed a damaged antenna coil and shield wires.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.This is believed to have been induced during revision surgery.The no lock condition prevented some electrical tests from being performed.The device failed the residual gas analysis test.This is an interim 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 a severed array as well as a damaged antenna coil and shield wires.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection confirmed a damaged antenna coil and shield wires.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.This is believed to be related to the damage to the antenna coil.The no lock condition prevented some electrical tests from being performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across some electrical components.The device passed some of the electrical tests performed.The device passed a mechanical test performed.The reported complaint of sound quality could not be verified during this analysis, which was limited in some respects due to the damage induced to the antenna during the revision surgery.However, this device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feed thru assemblies from this vendor are no longer used.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¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8967230
• MDR Text Key: 156761252
• Report Number: 3006556115-2019-00530
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR