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 Cellulitis (1768); Fever (1858); Pain (1994); Sepsis (2067); Vomiting (2144); Chills (2191)

Event Date 05/20/2021

Event Type  Injury  

Event Description

The recipient reportedly experienced pain at the implant site, fever, chills, nausea, and vomiting.He was admitted to the hospitalized on (b)(6) 2021.The recipient was diagnosed with sepsis due to cellulitis secondary to surgery.The recipient was treated with iv antibiotics.The recipient was discharged on (b)(6) 2021, and was given a 10 day oral antibiotic regiment.The recipient continues to recover on broad-spectrum antibiotics.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection reportedly resolved.The recipient's activation went well.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 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 12022526
• MDR Text Key: 257156654
• Report Number: 3006556115-2021-00816
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878008
• UDI-Public: (01)07630016878008(11)210330(17)240331
• 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
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR