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

Model Number AB-5100R

Device Problems Therapeutic or Diagnostic Output Failure (3023); Intermittent Communication Failure (4038)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing no lock.External equipment was exchanged, however, the issue did not resolve.

Manufacturer Narrative

The recipient's device was explanted.

Manufacturer Narrative

The recipient is believed to have experienced an in-situ failure.The recipient remains implanted.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.A review of the device history record was completed and no anomalies were noted.  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

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed damage to the epoxy header, braze, and ceramic case.These anomalies were believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires in the epoxy header region.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.The manual capacitor leakage test revealed reading that were unstable due to flooded components.The reported complaint of no lock could not be verified during this analysis, which was limited in some respects due to the device being damaged prior to receipt.This device had gross leak failure at the caseband braze, which is believed to have been induced during revision surgery.Due to the state of the device the root cause could not be determined.This older device configuration is not currently 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

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: 10445878
• MDR Text Key: 205082817
• Report Number: 3006556115-2020-00882
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2001
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR