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

Model Number AB-5100H

Device Problems Product Quality Problem (1506); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/04/2019

Event Type  Injury  

Event Description

The recipient will reportedly undergo explant surgery due to incomplete electrode insertion and sound quality issues.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

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

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed severed electrode wires at the epoxy header region.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.The reported complaint of intermittent malfunction could not be verified during this analysis, which was limited in some respects due to the electrode array being severed prior to receipt.This device passed all of the tests performed.This older device configuration is no longer manufactured.This is the final report.

Manufacturer Narrative

The external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical test performed.This is an interim report.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed severed electrode wires at the epoxy header region.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.The reported complaint of sound quality issues could not be verified during this analysis, which was limited in some respects due to the electrode array being severed prior to receipt.This device passed all of the tests performed.This older 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: 8896906
• MDR Text Key: 154419401
• Report Number: 3006556115-2019-00470
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2002
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR