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

Model Number CI-1600-04

Device Problems No Apparent Adverse Event (3189); Noise, Audible (3273)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Event Description

The recipient is reportedly experiencing decreased performance and crackling sounds with and without device use.A review of the recipient¿s test data indicated impedance issues.Programming adjustments were made.The recipient is also presenting with swelling on the same side the device is located.The recipient was given antibiotics for a possible sinus infection.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's issues have reportedly resolved.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: 10909522
• MDR Text Key: 218492057
• Report Number: 3006556115-2020-01490
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)160912(17)190831
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• 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): Required Intervention