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

Model Number AB-5100H

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/27/2019

Event Type  malfunction  

Event Description

The recipient reportedly experienced loss of lock.External equipment was exchanged, however, the issue did not resolve.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 external visual inspection revealed the electrode was severed prior to receipt.As well as damage to the epoxy header and braze.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection revealed breaks in the epoxy header region.This is believed to have occured during revision surgery.System lock could not be obtained at any spacing.The no lock condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection revealed that a resistor had a corroded trace.It is believed that the failure of this implantable cochlear stimulator (ics) device was caused by a loss of hermetic seal.This is concluded from the residual gas analysis test data.Moisture admitted into this device through this leak resulted in the corrosion of the resistive film material and the shift in resistance value of a resistor.This ultimately caused the device to cease functioning.This older device configuration is no longer manufactured.This is the final report.

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: 8800471
• MDR Text Key: 151442400
• Report Number: 3006556115-2019-00411
• 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
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2001
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR