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

Model Number CI-1601-04

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Rupture (2208)

Event Date 05/01/2021

Event Type  Injury  

Event Description

The recipient reportedly experienced an infection at the implant site in (b)(6) 2021.The recipient developed an abscess which ruptured and drained.The recipient was prescribed keflex for 2 weeks.The recipient's infection resolved.The recipient presented with device extrusion.The recipient's device was explanted.The recipient will be reimplanted at a later date.

Manufacturer Narrative

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

Manufacturer Narrative

The recipient reportedly will not be re-implanted.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 the electrode was cut 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 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: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 12235737
• MDR Text Key: 263810511
• Report Number: 3006556115-2021-01052
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016877995
• UDI-Public: (01)07630016877995(11)210210(17)240229
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/03/2021; 11/07/2021; 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male