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

Model Number CI-1601-05

Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Fistula (1862); Vertigo (2134); Dizziness (2194)

Event Date 03/18/2021

Event Type  Injury  

Event Description

The recipient reportedly experienced dizziness with and without device use since implantation.The surgeon believes the dizziness is a vestibular pathology issue.In addition, the recipient presented with symptoms consistent with a perilymph fistula and electrode contacts outside of the cochlea. the recipients device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient is doing well following revision surgery.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage on the top cover, and the electrode was sliced and severed along the lead and near the array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.The photographic imaging inspection confirmed cut electrode wires along the lead.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test performed.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: 11615613
• MDR Text Key: 243822931
• Report Number: 3006556115-2021-00376
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)190611(17)220531
• 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
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR