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

Model Number AB-5100R

Device Problems Defective Component (2292); Output below Specifications (3004)

Patient Problem No Code Available (3191)

Event Date 05/17/2018

Event Type  malfunction  

Event Description

The recipient reportedly experienced open electrodes and sound quality issues.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The recipient reportedly also experienced decreased performance.

Manufacturer Narrative

The external visual inspection revealed slices at the fantail region.This is believed to have occurred during revision surgery.The photographic imaging inspection noted broken electrode wires in the epoxy header region.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.This is the interim report.

Manufacturer Narrative

The external visual inspection revealed slices at the fantail region.This is believed to have occurred during revision surgery.The photographic imaging inspection noted broken electrode wires in the epoxy header region.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.It is believed that the failure of this device was caused by the broken electrode wires found in the epoxy header region.It is believed that these breaks caused the out of range impedance reported.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: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 7651558
• MDR Text Key: 113006481
• Report Number: 3006556115-2018-00274
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 06/04/2018

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: 10/12/1999
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/24/2018; 08/14/2018; 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/1997
• 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: 70 YR