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

Model Number CL-1500-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

The patient was reportedly experiencing overly loud stimulation and facial nerve stimulation around the contralateral eye.Programming adjustments were made; however this did not resolve the issue.Revision surgery has been scheduled.

Manufacturer Narrative

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

Manufacturer Narrative

The external visual inspection of the device revealed the electrode was severed near the electrode ground ring prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed all of the electrical tests performed.This is an interim report.

Manufacturer Narrative

The external visual inspection revealed the electrode was severed near the electrode ground ring prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed all of the electrical tests performed.This is an interim report.

Manufacturer Narrative

The external visual inspection revealed the electrode was severed near the ground electrode ring prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The reported complaint of overly loud sound could not be verified during this analysis, which was limited in some respects due to the electrode being cut prior to receipt.The device passed the tests performed.This is the final report.

• Brand Name: HIRES 90K ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342
• Manufacturer Contact: pamela campo ; 28515 westinghouse place; valencia, CA 91355 ; 6613627624
• MDR Report Key: 4921049
• MDR Text Key: 6431387
• Report Number: 3006556115-2015-00313
• 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,health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: CL-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• 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: 12 YR