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

Model Number CI-1400-02H

Device Problem Protective Measures Problem (3015)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/25/2018

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing sound quality issues and open electrodes.Programming adjustment were made, however, the issue did not resolve.Revision surgery is 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 sliced silastic on the fantail region and at the straight portion of the array.In addition, the silastic overmold was damaged on both top and bottom covers.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed several broken electrode wires at the fantail region.In addition, cut electrode wires observed on the fantail and the straight portion of the array.These are believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The photographic imaging inspection and the scanning electron microscopy analysis revealed evidence of fatigue breaks on six electrode wires at the fantail region.These breaks can be associated with the sound quality and the amount of open electrodes reported.A corrective action was implemented.This is the final report.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.

• Brand Name: HIRES 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 7922905
• MDR Text Key: 122469354
• Report Number: 3006556115-2018-00451
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2010
• 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: 14 YR