MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-05

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

Patient Problems Syncope (1610); Bruise/Contusion (1754); Nerve Damage (1979)

Event Type  Injury  

Event Description

The recipient's jaw nerve was reportedly cut during implant surgery.The recipient reportedly presented with a warm sensation a couple of days after surgery and fainted.The recipient was prescribed medication for the jaw.The recipient was evaluated prior to device activation and was also observed to have a bruised tympanic membrane.Programming adjustments were made, however, the issue did not resolve.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

The recipient is reportedly doing okay.

Event Description

The recipient's jaw nerve was reportedly cut during implant surgery.The recipient was prescribed medication for the jaw.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain additional information regarding registration were unsuccessful.No further information will be provided.This is the final report.

Manufacturer Narrative

The center reportedly did not request additional support for the recipient from advanced bionics.The center will follow-up and contact advanced bionics if assistance for the recipient is needed.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8529410
• MDR Text Key: 142460133
• Report Number: 3006556115-2019-00170
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention