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

Model Number CI-1601-04

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Head Injury (1879); Unspecified Infection (1930); Blood Loss (2597)

Event Date 03/22/2020

Event Type  Injury  

Event Description

The recipient reportedly experienced head trauma and presented with an infection above the incision site in (b)(6) 2020.On (b)(6) 2020, it was noted that the recipient was oozing a clear fluid.Antibiotics were prescribed, and the recipient was recommended to cease device use for 2 to 4 weeks.In (b)(6) 2020, the recipient¿s incision site began to fill up with fluid and bleed, and the recipient's device became exposed.The recipient's device was 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 infection reportedly resolved.The external visual inspection revealed silicone slices on the top cover and fantail prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed all electrode wires were cut at the fantail.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.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 reportedly experienced decreased performance.The external visual inspection revealed silicone slices on the top cover and fantail prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed all electrode wires were cut at the fantail.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical tests performed.Advanced electrical testing performed on the device revealed lower than typical range on some of the electrodes.It is the opinion of advanced bionics explant review board that some of these electrode test results should be considered as failures.The scanning electron microscopy (sem) analysis revealed corrosion on some electrodes.The device passed the mechanical test performed.This device was explanted for medical reasons.However, the failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.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
• MDR Report Key: 9998054
• MDR Text Key: 188979533
• Report Number: 3006556115-2020-00245
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)190423(17)220430
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 MO