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

Model Number CI-1500-04

Device Problem Product Quality Problem (1506)

Patient Problem Hearing Impairment (1881)

Event Date 03/08/2019

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing sounds quality issues.The recipient has some electrodes deactivated.Revision surgery is scheduled.

Manufacturer Narrative

The recipient reportedly experienced shorted electrodes.Programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Event Description

The recipient is reportedly experiencing shorted electrodes and sound quality issues due to partial electrode insertion.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed a dislodged electrode ground ring sleeve.In addition, there was a missing contact pad on an electrode channel and an extruded contact pad on another electrode channel.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires at the straight portion of the array.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode array revealed damaged parylene wire coating on an electrode near another electrode contact pad.Damage to parylene wire coating was found on an electrode near another electrode contact pad within the array.Although no electrode shorts were electrically verified, the damage could have caused shorts while implanted in the recipient's cochlea.This is the first incidence of this failure mode.Advanced bionics will continue to monitor failure modes of this type and will implement corrective actions as necessary.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8337329
• MDR Text Key: 136493662
• Report Number: 3006556115-2019-00044
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016832185
• UDI-Public: (01)07630016832185(11)160816(17)190731
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2019

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: 07/31/2019
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/14/2019; 04/05/2019; 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR