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

Model Number CI-1400-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hearing Impairment (1881)

Event Date 08/22/2015

Event Type  malfunction  

Manufacturer Narrative

Udi number: na.

Event Description

The patient reportedly experienced loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue was not resolved.The patient's device was explanted.The patient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Manufacturer Narrative

The external visual inspection revealed cuts on the electrode lead as well as scratches on the platinum disk.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed broken electrode wires.This is believed to have occurred during revision surgery.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 one of the electrical tests performed.The device passed the mechanical test performed.This is an interim report.

Manufacturer Narrative

The external visual inspection revealed cuts on the electrode lead as well as scratches on the platinum disk.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.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 one of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across some electrical components.This device had moisture that exceeded the residua gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action has been implemented.Feedthru assemblies from this vendor are no longer used.This is the final report.This report may be required by medical device reporting regulations contained in title 21 part 803.As provided in the title 21 section 803.16, it does not establish any causal relationship between this device and any event associated with use of the device, nor does advanced bionics® intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: pamela campo ; 28515 westinghouse place; valencia, CA 91355 ; 6613627624
• MDR Report Key: 5072261
• MDR Text Key: 26076321
• Report Number: 3006556115-2015-00426
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Audiologist
• Type of Report: Followup,Followup
• Report Date: 08/22/2015

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: 04/30/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2015; 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2005
• 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: 16 YR