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

Model Number CI-1601-04

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing open electrodes and sound quality issues.Revision surgery is scheduled.

Manufacturer Narrative

Additional information: the recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.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 silicone damage on the top and bottom covers, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic inspection revealed cut wires along the lead.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.The scanning electron microscopy (sem) analysis confirmed cut wires along the lead, which are believed to have occurred during revision surgery.The reported complaint of open electrodes could not be verified during this analysis, which was limited in some respects due to the electrode being cut prior to receipt.This device passed all of the tests performed.This version of the ultra is no longer distributed.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: 10642372
• MDR Text Key: 211689682
• Report Number: 3006556115-2020-01080
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)191202(17)221130
• 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
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR