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

Model Number AB-5100H

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hearing Impairment (1881)

Event Date 08/28/2015

Event Type  malfunction  

Event Description

The recipient reportedly experienced no sound followed by loss of lock.External equipment was exchanged, however this did not resolve the issue.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The external visual inspection revealed that the electrode was severed prior to receipt as well as damage to the epoxy header and fantail region.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires at the fantail region.This is believed to have occurred during revision surgery.System lock was lost during stimulation.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device did not pass the residual gas analysis test.The internal visual inspection revealed that one of the resistors had degraded traces.It is believed that the failure of this implantable cochlear stimulator (ics) device was caused by a loss of hermetic seal.This is concluded from the residual gas analysis data.Moisture admitted into this device through this leak resulted in the degraded resistance film material and the shift in a resistance value.This is ultimately caused the device to cease functioning.This older 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: nicole birch ; 28515 westinghouse place; valencia, CA 91355 ; 6613621528
• MDR Report Key: 5088332
• MDR Text Key: 26479281
• Report Number: 3006556115-2015-00432
• 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: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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: 16 YR