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

Model Number CI-1400-01

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191); Intermittent Communication Failure (4038)

Patient Problem Failure of Implant (1924)

Event Date 03/18/2021

Event Type  malfunction  

Event Description

The recipient reportedly experienced intermittent lock.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

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool damage and torn silicone on the top and bottom covers.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires.System lock was verified.The device passed some of the electrical tests performed.The device failed residual gas analysis test.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.In addition, x-ray inspection revealed broken wires in the fantail region.This version of the hires 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.

• 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: 11635457
• MDR Text Key: 258653721
• Report Number: 3006556115-2021-00371
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2006
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR