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

Model Number CI-1400-01

Device Problem Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

The recipient reportedly experienced sound quality issues.Device testing revealed the device was not functioning within specification.The recipient's device was explanted.The recipient was reimplanted with another cochlear device.

Manufacturer Narrative

Additional information: returned to manufacturer.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.This is the final report.

Manufacturer Narrative

The external visual inspection revealed the electrode was damaged along the lead and severed near the array prior to receipt.This is 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 several of the electrical tests from being performed.The device passed one of the electrical tests performed.The device failed the residual gas analysis test.This device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A capa was implemented.Feedthru assemblies from this vendor are no longer used.This is the final report.

• 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: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 4487704
• MDR Text Key: 5564371
• Report Number: 3006556115-2015-00046
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2005
• 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: 15 YR