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

Model Number CI-1601-05

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Pain (1994); Tinnitus (2103)

Event Date 01/18/2022

Event Type  Injury  

Event Description

The recipient reportedly experienced sound quality issues and decreased performance.Programming adjustments were made, however, the issues did not resolve.The recipient's device was reportedly explanted.The recipient was reimplanted with another cochlear device.

Manufacturer Narrative

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 recipient's device issues started after the car accident.In addition, the recipient experienced pain and increased tinnitus.The recipient has healed following revision surgery.The external visual inspection revealed that the electrode was severed.Slices in the silicone were also observed on the top cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.The device passed the tests performed.This version of the ultra device 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
• Manufacturer Contact: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 13831238
• MDR Text Key: 293931100
• Report Number: 3006556115-2022-00434
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016870262
• UDI-Public: (01)07630016870262(11)190424(17)220430
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female