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

Model Number MMT-5100R

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Head Injury (1879); Insufficient Information (4580)

Event Date 05/17/2022

Event Type  Injury  

Event Description

The recipient's device was reportedly explanted.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

The recipient reportedly experienced poor performance after a car accident 15 years ago.The recipient had become a non-user of the device.The recipient elected for revision surgery.The recipient was not reimplanted.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's magnet was de-magnetized and the cochlear implant was severely damaged from the head trauma.Device testing prior to explant surgery was not possible.The recipient has healed without complications.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.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.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
• Manufacturer Contact: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 14526931
• MDR Text Key: 292958548
• Report Number: 3006556115-2022-00858
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/15/1997
• Device Model Number: MMT-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/1995
• 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 Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male