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

Model Number AB-5100H-11A

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing no sound.External equipment was exchanged and sound quality improved, however, the surgeon decided to proceed with revision surgery.

Manufacturer Narrative

Additional information: the recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.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 the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device failed the residual gas analysis test.It is believed that the failure of this implantable cochlear stimulator was caused by a loss of hermetic seal, which was concluded from the residual gas analysis test data.This ultimately caused the 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: 10495549
• MDR Text Key: 206957211
• Report Number: 3006556115-2020-00933
• 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
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2004
• Device Model Number: AB-5100H-11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR