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

Model Number MMT-5100R

Device Problem Intermittent Continuity (1121)

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

Event Date 09/11/2018

Event Type  malfunction  

Event Description

The recipient reportedly experienced intermittencies with device use.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.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 elected revision surgery for a technology upgrade due to poor battery life.

Manufacturer Narrative

According to a user report received by the nca, the device was reportedly given to the manufacturer.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Prior to explant surgery, external equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The external visual inspection revealed that 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 some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The residual gas analysis could not be performed due to the ceramic case cracking while attempting to pull vacuum.The reported complaint of intermittent malfunction could not be verified during this analysis, which was limited in some respects due to the electrode array being cut prior to receipt, as well as damage induced during the residual gas analysis.This device passed all of the electrical tests performed.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: 8028678
• MDR Text Key: 126223910
• Report Number: 3006556115-2018-00511
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/1996
• Device Model Number: MMT-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/1995
• 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 Age: 57 YR