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

Model Number CI-1400-01

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number: na.

Event Description

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

Manufacturer Narrative

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

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.The external visual inspection revealed the electrode was severed at the flange and near the array prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed electrode damage at the flange near the fantail.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 an electrical test performed.The device failed the residual gas analysis test.This is the final report.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.This is the final report.

Manufacturer Narrative

The external visual inspection revealed tool marks on the top and bottom covers and along the seam weld, and the electrode was severed at the flange and near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed electrode damage at the flange near the fantail.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 an electrical test performed.The device failed the residual gas analysis test.The scanning electron microscopy analysis revealed tool mark damage on the seam weld.This is believed to have occurred during revision surgery.The internal visual inspection noted silver migration on some electrical components.The residual gas analysis result was above the nitrogen limit.This result is due to a gross leak from damage to the seam weld, which is believed to have occurred during revision surgery.This device had moisture that exceeded the residual gas analysis test limit.Leak testing of the feedthru assembly did not reveal any leaks.Corrective actions have been implemented.This is the final report.

• Brand Name: HIRES 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355 ; 6613621741
• MDR Report Key: 6867516
• MDR Text Key: 86589393
• Report Number: 3006556115-2017-00509
• 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,Followup
• Report Date: 08/24/2017

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: 11/30/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2017; 01/16/2018; 01/04/2019; 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2005
• 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: 57 YR