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

Model Number CI-1600-04

Device Problems Expulsion (2933); Material Protrusion/Extrusion (2979)

Patient Problems Bacterial Infection (1735); Edema (1820); Necrosis (1971); Necrosis Of Flap Tissue (1972); Staphylococcus Aureus (2058); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

The recipient reportedly experienced chronic edema for two months that temporarily resolved with medical treatment and discontinued use of the device.On (b)(6) 2020, the edema was cultured, and was (b)(6) for (b)(6) on (b)(6) 2020, the recipient presented with skin flap necrosis and the device extrusion.The recipient's device was explanted.The recipient was not reimplanted.

Manufacturer Narrative

The recipient's infection has resolved.

Manufacturer Narrative

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

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly presented with chronic edema two months post implantation surgery.Additional treatment details will not be provided.The external visual inspection revealed the array was severed prior to receipt.This is 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.This device was explanted for medical reasons.The device passed the tests performed.This version of the ultra device is no longer distributed.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: 10126039
• MDR Text Key: 194292072
• Report Number: 3006556115-2020-00423
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016861727
• UDI-Public: (01)07630016861727(11)190701(17)220630
• 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,Followup
• Report Date: 05/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention