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

Model Number AB-5100H

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 12/16/2019

Event Type  Injury  

Event Description

The recipient is reportedly experiencing non-auditory sensations.The recipient is presenting with discomfort.Revision surgery is scheduled.

Manufacturer Narrative

Prior to revision surgery, external equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient's activation went well.

Manufacturer Narrative

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

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The device passed the external visual inspection.The photographic imaging inspection revealed extruded contact pad at an electrode.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical tests performed.The device failed the residual gas analysis test.The reported complaint of non-auditory sensation could not be verified during this analysis.However, the device had moisture content that exceeded the residual gas analysis test limit.Based on an assessment on the residual gas analysis test data, it is believed that this device was not hermetic.This older device configuration is no longer manufactured.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The device passed the external visual inspection.System lock was verified.The device passed the electrical test performed.This is an interim report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: CLARION¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9256562
• MDR Text Key: 164312579
• Report Number: 3006556115-2019-00633
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2002
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR