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 05/22/2019

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 external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.This is an interim report.

Manufacturer Narrative

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

Manufacturer Narrative

The external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.This is an interim report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed a dented bottom cover.In addition, the electrode was severed prior to receipt, which is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained after temperature exposure.The electrode condition prevented some 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.Based on an assessment of the residual as analysis test, helium leak test, dye penetrant test and getter absorption test data, it is determined that this device was non-hermetic, and the root cause of the excessive moisture was a leak through the feedthru seals.A corrective action was implemented.This is the final.Disclaimer: advanced bionics does not 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
• MDR Report Key: 8692905
• MDR Text Key: 148011205
• Report Number: 3006556115-2019-00324
• 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,user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2019

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: 04/01/2012
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/02/2019; 11/20/2019; 12/18/2019; 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR