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

Model Number AB-5100H

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device on the contralateral side.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Advanced bionics was informed that the recipient's device was reportedly not explanted.The recipient will not be explanted at this time.The recipient was not reimplanted with another advanced bionics cochlear implant.No further details will be provided.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: 10365432
• MDR Text Key: 201670414
• Report Number: 3006556115-2020-00761
• 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
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention