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

Model Number CI-1500-01

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 02/29/2016

Event Type  Injury  

Event Description

The recipient reportedly experienced a facial nerve tear during initial implant surgery.The recipient underwent a facial nerve decompression surgical procedure.Advanced bionics is in the process of gathering more information.Once additional information is received a supplemental report will be submitted.

Event Description

The recipient reportedly experienced an exposed facial nerve during initial implant surgery.The recipient underwent a facial nerve decompression surgical procedure.The recipient is reportedly doing fine.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The company was informed that no medical intervention was performed due to the exposed facial nerve.The recipient's device remains implanted.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: nicole birch ; 28515 westinghouse place; valencia, CA 91355 ; 6613621528
• MDR Report Key: 5823634
• MDR Text Key: 50509103
• Report Number: 3006556115-2016-00316
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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: 8 YR