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

Model Number MMT-5100R

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Code Available (3191)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The device passed the external visual and photographic imaging inspections.System lock was verified.The device passed the electrical tests performed.The residual gas analysis could not be performed due to damage the device sustained during failure analysis.This device was explanted for medical reasons.The device passed the tests performed.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: brooke lopez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 9720684
• MDR Text Key: 183921396
• Report Number: 3006556115-2020-00064
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/1993
• Device Model Number: MMT-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/1991
• 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: 52 YR