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

Model Number AB-5100L

Device Problems Application Program Version or Upgrade Problem (2881); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2021

Event Type  malfunction  

Event Description

The recipient reportedly elected revision surgery for a technology upgrade.The recipient's device was explanted.The recipient was reimplanted with another cochlear implant.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool damage to the epoxy header and seam weld.In addition, there was a missing contact pad on an electrode.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.This is believed to be caused by damaged induced during revision surgery.The device manual capacitor test revealed readings that were unstable due to flooded components.This is believe to have been caused by damage induced during revision surgery.This device was explanted for medical reasons.However, this device had a gross leak failure at the caseband braze, which is believed to have been induced during revision surgery.This older device configuration is not currently manufactured 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: 12489079
• MDR Text Key: 273096762
• Report Number: 3006556115-2021-01378
• 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
• Type of Report: Initial,Followup
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/06/2002
• Device Model Number: AB-5100L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2000
• 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: 21 YR