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

Model Number CI-1400-01

Device Problems Poor Quality Image (1408); Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

The pt reportedly experienced sound quality issues with the device.Programming adjustments were made and external equipment was exchanged.However, the issue was not resolved.Testing revealed the device is not functioning within specifications.Revision surgery will be scheduled.

Manufacturer Narrative

The external visual inspection revealed dents on the bottom cover of the device.This is believed to have occurred during revision surgery.Photographic imaging inspection confirmed dents on the bottom cover of the device.This is believed to have occurred during revision surgery.System lock was verified.The device passed some of the electrical tests performed.The device did not pass the residual gas analysis test.This is an interim report.

Manufacturer Narrative

The external visual inspection revealed dents on the bottom cover of the device.This is believed to have occurred during revision surgery.Photographic imaging inspection confirmed dents on the bottom cover of the device.This is believed to have occurred during revision surgery.System lock was verified.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.Internal visual inspection revealed silver migration was noted between and across some of the electrical components.This device had moisture that exceeded the residual gas analysis test limit.Based on an assessment of residual gas analysis and helium leak data, it is believed that this device was non-hermetic, and the root cause of the excessive moisture was leak through the feedthru seals.A corrective action has been implemented.This is the final report.

Manufacturer Narrative

The patient's device was explanted.The patient was reimplanted with another advanced bionics cochlear device.The patient is reportedly doing well with the new device.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342
• Manufacturer Contact: nicole birch, associate ; 12740 san fernando rd.; sylmar, CA 91342 ; 6613621528
• MDR Report Key: 4580105
• MDR Text Key: 5451881
• Report Number: 3006556115-2015-00075
• 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,health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2015

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: 06/30/2010
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/07/2015; 07/01/2015; 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2008
• 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: 9 YR