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

Model Number CI-1600-05

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 09/10/2019

Event Type  Injury  

Event Description

The recipient was reportedly a non-user of the device.The recipient reportedly ceased device use due to facial nerve stimulation.The recipient's device was explanted.

Manufacturer Narrative

The recipient was reimplanted with another cochlear device.The recipient is doing well following revision surgery.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient¿s device will not return to advanced bionics for analysis.A review of the device history record was completed and no anomalies were noted.Additional treatment details will not be provided.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 ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9169302
• MDR Text Key: 161805028
• Report Number: 3006556115-2019-00600
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016844584
• UDI-Public: (01)07630016844584(11)180709(17)210630
• 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,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: CI-1600-05
• 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
• Patient Age: 76 YR