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

Model Number CI-1600-04

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Inflammation (1932); Ulcer (2274); Organ Dehiscence (2502)

Event Date 10/21/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced an infection.During the postoperative period, the recipient experienced dehiscence that healed on its own.As time progressed, the recipient presented with inflammation on the skin flap which subsequently ulcerated and suppurated.The recipient's device was explanted.During explant surgery, the electrode was found to be wrapped in biofilm tissue and granular mastoiditis was noted.The recipient is undergoing treatment.

Manufacturer Narrative

The recipient reportedly finished the antibiotic treatment.The recipient's infection resolved.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

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 was reportedly not reimplanted.The external visual inspection revealed silicone slices on the top cover and the electrode was severed near the electrode ground ring prior to receipt.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.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 IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9328628
• MDR Text Key: 166573383
• Report Number: 3006556115-2019-00689
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016861703
• UDI-Public: (01)07630016861703(11)180430(17)210430
• 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,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR