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

Model Number CI-1500-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Facial Nerve Paralysis (1846)

Event Date 03/01/2019

Event Type  Injury  

Event Description

The recipient is reportedly experiencing facial nerve paralysis that is believed to be due to implant surgery.The recipient is undergoing rehabilitation and is recovering.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly recovered.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
• MDR Report Key: 8808816
• MDR Text Key: 151639978
• Report Number: 3006556115-2019-00433
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)181214(17)201130
• 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
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/20/2019; 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR