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 Bacterial Infection (1735); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The recipient is reportedly experiencing an infection following initial device implant surgery.The recipient was reportedly hospitalized.The recipient was reportedly diagnosed with cipro resistant pseudomonas.The recipient was reportedly first prescribed bactrim.On (b)(6) 2023 the recipient was seen and prescribed amoxicillin (125 mg for 21 days), and mupirocin ointment (2-3 times a day).Recipient was seen again on (b)(6) 2023 with worsening drainage at the incision site.The recipient was then changed to doxycycline (100 mg 2 times a day for 15 days), and ocuflux drops on the incision.On (b)(6) 2023 the ocuflux drops were changed to cortisporin.The recipient reportedly has a picc line inserted and will be on a six week course of zosyn.The recipient was reportedly advised to cease device use, however, the recipient is currently wearing the processor off the ear.The recipient will follow up with infectious disease.

Manufacturer Narrative

The recipient's device was explanted.During revision surgery mastoid effusion and necrotic tissue was sent for cultures and came back positive for pseudomonas.The recipient is reportedly admitted to the hospital and was prescribed a 4 week course of iv antibiotics (zosyn).Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient is reportedly healing well and off antibiotics.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 explanted device is reportedly lost and will not be returned to the company.A review of the device history record noted no rework.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

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
• Manufacturer Contact: heidi white ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 18012714
• MDR Text Key: 326628444
• Report Number: 3006556115-2023-01836
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 00840094456020
• UDI-Public: (01)00840094456020(11)230126(17)260131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male