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

Model Number CI-1600-04

Device Problems Application Program Problem (2880); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing decreased performance.Programming adjustments were made, however, the issue did not resolve.Revision surgery is under consideration.

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.The recipient¿s device was lost and will not return to advanced bionics for analysis.A review of the device history record was completed and no anomalies were noted.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: 10367838
• MDR Text Key: 202705551
• Report Number: 3006556115-2020-00769
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170224(17)200229
• 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: 07/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• 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 Age: 6 YR