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

Model Number AB-5100H

Device Problem Defective Device (2588)

Patient Problems Hearing Impairment (1881); Therapeutic Response, Decreased (2271)

Event Date 03/14/2019

Event Type  malfunction  

Event Description

The recipient reportedly elected explant surgery due to a defect in the electrode.The recipient presented with decreased performance and sound quality issues.The recipient's device was explanted.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly healed following surgery.The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.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 an electrical test performed.The failure of this device is attributed to excessive moisture through a gross leak at the case-band braze.This ultimately caused this device to cease functioning.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.

• Brand Name: CLARION¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8624749
• MDR Text Key: 145623144
• Report Number: 3006556115-2019-00271
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2002
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR