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

Model Number CI-1400-01

Device Problem Disconnection (1171)

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

Event Date 02/06/2019

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient's device was explanted.The recipient was not reimplanted due to the presence of a cholesteatoma.

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 surgical tool marks were 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 verified.The electrode condition prevented some of the electrical tests from being performed.The device passed some 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 feeedthru vendor.A corrective action 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; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8380565
• MDR Text Key: 137805085
• Report Number: 3006556115-2019-00071
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR