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

Model Number AB-5100R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/08/2016

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing open electrodes and non-auditory sensations with and without device use.Programming adjustments were made, however, the issue is not resolved.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 that the electrode was severed prior to receipt as well as damage to the epoxy header region and slices at the fantail region.All of these anomalies are 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 tests performed.The device failed the residual gas analysis test.The internal visual inspection revealed cracked epoxy at the feedthru joints.The reported complaint of non-auditory sensation, pain, and discomfort could not be verified during this analysis, which was limited in some respects due to the electrode lead being severed prior to receipt.The device passed the electrical tests performed.However, the device had moisture content that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis and dye penetrant data, it is believed that this device was not hermetic.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: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 6230919
• MDR Text Key: 64511589
• Report Number: 3006556115-2016-00575
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/1999
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/1997
• 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: 48 YR