MAUDE Adverse Event Report: HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT

Model Number CI-1500-04

Device Problems Electrical /Electronic Property Problem (1198); No Audible Prompt/Feedback (2282)

Patient Problems Hearing Impairment (1881); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

The recipient reportedly experienced no sound.Programming adjustments were made, however, the recipient is now presenting with sound quality issues.Additional programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.External visual inspection revealed tool damage to the top and bottom covers.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.Internal visual inspection revealed a cracked hybrid.The reported complaint of no sound and open electrodes with the device was verified during the analysis.The device was received with multiple cracks along the hybrid.A corrective action was implemented.This is the final report.

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.External visual inspection revealed tool damage to the top and bottom covers.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.Internal visual inspection revealed a cracked hybrid.The reported complaint of no sound and open electrodes with the device was verified during the analysis.The device was received with multiple cracks along the hybrid.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¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• MDR Report Key: 10280020
• MDR Text Key: 199532353
• Report Number: 3006556115-2020-00614
• 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
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2014
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2013
• 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: 81 YR