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

Model Number CI-1400-02H

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing loss of lock.External equipment was exchanged, however, the issue did not resolve.Revision surgery is under consideration.

Manufacturer Narrative

Additional information: device testing revealed open electrodes.Revision surgery is scheduled.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 reportedly 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

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 electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.The photographic imaging inspection revealed broken wires in the fantail region.It is believed that these breaks caused the no sound output.This version of the hires 90k device is no longer distributed.A corrective action was implemented.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: 10706026
• MDR Text Key: 213684318
• Report Number: 3006556115-2020-01142
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR