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

Model Number CI-1600-04

Device Problems Impedance Problem (2950); Output below Specifications (3004); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing decreased performance.A review of the recipient¿s test data indicated impedance issues.Revision surgery is scheduled.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.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: 11871793
• MDR Text Key: 255351669
• Report Number: 3006556115-2021-00690
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170802(17)200731
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR