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 Unspecified Infection (1930); Swelling (2091)

Event Date 11/11/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced an ear infection and was placed on antibiotics, but the infection spread causing the ear to swell.The recipient's device was explanted.The recipient will be reimplanted at a later date.The recipient was placed on iv antibiotics.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly recovered.The external visual inspection revealed the electrode was severed near the electrode ground ring prior to receipt.This is 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.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.

• 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: 9440887
• MDR Text Key: 170010268
• Report Number: 3006556115-2019-00725
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)180904(17)210831
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 MO