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

Model Number CI-1400-01

Device Problems No Audible Prompt/Feedback (2282); Application Program Problem (2880)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing intermittent lock and sound quality issues.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

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

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed near the fantail and damaged silicone overmold was observed on both top and bottom covers prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained intermittently.The electrode 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 internal visual inspection noted silver migration across some electrical component.This device had moisture that exceed 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.

• 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
• MDR Report Key: 8011388
• MDR Text Key: 125361324
• Report Number: 3006556115-2018-00500
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2006
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2004
• 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: 63 YR