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

Model Number CI-1400-02H

Device Problems No Audible Alarm (1019); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/22/2017

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing sound quality issues, open circuits, and decrease in performance.External equipment was exchanged and programming adjustments were made, however, the issue is not resolved.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The external visual inspection revealed toolmarks on the top and bottom covers, a dent in the bottom cover and the contact pad at an electrode was extruded prior to receipt.This is believed to have occurred during revision surgery the device passed the photographic imaging inspection revealed multiple broken electrode wires at the fantail region.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.A scanning electron microscopy analysis of the electrode confirmed multiple fatigue breaks at the fantail region.It is believed that these breaks caused the report of open electrodes, sound quality issues, decreased performance.A capa was implemented this is the final report.

• Brand Name: HIRES 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: pamela campo ; 28515 westinghouse place; valencia, CA 91355 ; 6613627624
• MDR Report Key: 6632670
• MDR Text Key: 77276712
• Report Number: 3006556115-2017-00276
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2008
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR