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

Model Number CI-1600-04

Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Discharge (2225); Skin Tears (2516)

Event Type  Injury  

Event Description

The recipient reportedly experienced an infection and skin flap breakdown.In (b)(6) 2019, the recipient presented with pain and discharge at the implant site.The recipient was prescribed a two weeks course of oral antibiotic.On (b)(6) 2019, the recipient was prescribed a course of clindamycin.On (b)(6) 2019, the recipient presented with device extrusion and the recipient was hospitalized for iv antibiotics.On (b)(6) 2020 the recipient's device was explanted.The recipient's infection resolved and wound healed.On (b)(6) 2020, the recipient was reimplanted with another advanced bionics cochlear device.The recipient¿s device will not return to advanced bionics for analysis.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Additional treatment details will not be provided.A review of the device history record revealed that silicone was removed from the open end of the lumen.Open end of the lumen is where the stylet is inserted for the ms electrode.This is believed to be unrelated to the complaint reason.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 IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 11353713
• MDR Text Key: 232789961
• Report Number: 3006556115-2021-00098
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170831(17)200831
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• 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