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

Model Number CI-1500-04

Device Problem Material Deformation (2976)

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

Event Date 02/06/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced a tip fold over of the electrode array.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient's activation went well.

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.This is the final report.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the silicon was damaged on the top cover and the fantail was sliced prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.The device was explanted for medical reasons.The device passed the tests performed.This is the final report.

• Brand Name: HIRES 90K¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: brooke lopez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 8326077
• MDR Text Key: 135734200
• Report Number: 3006556115-2019-00036
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016828638
• UDI-Public: (01)07630016828638(11)160202(17)181231
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR