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

Model Number CI-1600-04

Device Problem Microbial Contamination of Device (2303)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

The recipient reportedly experienced a middle ear infection which led to the implant site.The recipient presented with swelling and pain.The recipient is using a peripherally inserted central catheter (picc) line.The recipient was treated for a possible biofilm formation.The recipient was prescribed antibiotics.

Manufacturer Narrative

The recipient was reportedly hospitalized for over a week due to the implant being infected.The recipient was discharged.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection reportedly resolved.Additional treatments details were not provided.The recipient resumed device use.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

The recipient reportedly experienced infections in december 2018 to january 2019 and in october 2019.Both infections resolved with antibiotics.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: 9495549
• MDR Text Key: 172033152
• Report Number: 3006556115-2019-00767
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)171012(17)201031
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: CI-1600-04
• 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