MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT

Model Number CI-1400-01

Device Problems Device Inoperable (1663); Programming Issue (3014)

Patient Problem No Code Available (3191)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery is under consideration.

Manufacturer Narrative

Revision surgery is reportedly scheduled.

Manufacturer Narrative

The external visual inspection revealed the electrode array was cut prior to receipt as well as the damage to the silastic overmold on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed some the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across an electrical component.The device had moisture that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis and dye penetrant data, it is believed that this device was non-hermetic, and that the root cause of the excessive moisture was a leak through the feedthru seals.A corrective action was implemented.This is the final report.

Manufacturer Narrative

The recipient's device was explanted.The recipient was reimplanted with another advance bionics cochlear device.

• Brand Name: HIRES 90K¿ 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 ; 6613621741
• MDR Report Key: 7159061
• MDR Text Key: 96390898
• Report Number: 3006556115-2017-00724
• 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: Audiologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2006
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2004
• 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: 20 YR