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

Model Number MMT-5100L

Device Problems Electrical /Electronic Property Problem (1198); Noise, Audible (3273); Intermittent Communication Failure (4038)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Event Description

Advanced bionics was notified that the recipient was experiencing sound quality issues and poor battery life.The recipient's device was explanted.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

The recipient's device was 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.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.The reported complaint of sound quality could not be verified during this analysis, which was limited in some respects due to the electrode being severed prior to receipt.However, it is believed that the failure of this ics device was caused by a loss of hermetic seal, which was concluded from the assessment of the residual gas analysis data.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.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient was re-implanted on (b)(6) 2023 with another advanced bionics cochlear device.Advanced bionics received permission on behalf of the recipient to proceed with failure analysis on (b)(6) 2023.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: lacey o'linn ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 16151580
• MDR Text Key: 307496299
• Report Number: 3006556115-2023-00070
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/1996
• Device Model Number: MMT-5100L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2023; 05/04/2023; 05/30/2023; 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/1994
• 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: 61 YR
• Patient Sex: Male