MAUDE Adverse Event Report: ADVANCED BIONICS, LLC CLARION¿ IMPLANT; COCHLEAR IMPLANT

Model Number AB-5100H

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

Event Type  malfunction  

Event Description

The recipient reportedly experienced a potential device failure.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The device passed the external visual and photographic imaging inspections.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical test performed.This is an interim report.

Manufacturer Narrative

The device passed the external visual and photographic imaging inspections.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection revealed that a resistor had a corroded trace.It is believed that the failure of this device was caused by a loss of hermetic seal.This is concluded from the residual gas analysis data and intrusion of the dye penetrant into the implantable cochlear stimulator (ics) inner cavity, due to a fine leak failure in the feed thru assembly.Moisture admitted into this device through this leak resulted in the corrosion of the resistive film material and the shift in resistance value of a resistor.This ultimately caused the device to cease functioning.This older device configuration is no longer manufactured.This is the final report.

• Brand Name: CLARION¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 7723015
• MDR Text Key: 115361212
• Report Number: 3006556115-2018-00359
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2002
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2000
• 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: 22 YR