MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-05

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Date 03/24/2021

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 pain over the implant site and retention issues due to swelling at the implant site.From (b)(6) 2021, to (b)(6) 2021, the recipient was given a 10 day course of antibiotics, however, the issue did not resolve.External equipment was exchanged, however, the issue did not resolve.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

The recipient reportedly has an infection.Revision surgery will be scheduled.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's device was explanted.The recipient will be reimplanted at a later date.The recipient has healed and the infection resolved.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 external visual inspection revealed cuts on the top cover and bottom cover, the fantail, and electrode.In addition, the electrode was severed prior to receipt.These are 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 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: 11742407
• MDR Text Key: 247904840
• Report Number: 3006556115-2021-00500
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)190916(17)220831
• 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,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR