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

Model Number MMT-5100L

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Date 07/19/2018

Event Type  malfunction  

Event Description

The recipient elected revision surgery for a technology upgrade.The recipient's device was explanted.

Manufacturer Narrative

Advanced bionics reportedly considers the investigation into this reportable event as closed.The recipient reportedly experienced decreased performance.The external visual inspection revealed that the silicone overmold was cut at the electrode lead.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.The device failed the residual gas analysis test.The reported complaint of decrease in performance could not be verified during this analysis.The device passed all of the electrical tests performed.However, the device had moisture content that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis data it is believed that this device was not hermetic.This older device configuration is no longer manufactured.This is the final report.

• Brand Name: CLARION¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 7997554
• MDR Text Key: 124817475
• Report Number: 3006556115-2018-00485
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/11/1996
• Device Model Number: MMT-5100L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/1994
• 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: 62 YR