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

Model Number CI-1600-04

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

The recipient is reportedly experiencing chronic pain, swelling at the implant site, and recurrent infections.The recipient's device was explanted.

Manufacturer Narrative

The external visual inspection revealed a silicone slice on the top cover, and the electrode was severed near the fantail and array prior to receipt.These are believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented and 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.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's incision site had reportedly opened leading to infection.The recipient was treated with cipro for pain and swelling.The recipient's infection was not device related.The recipient is healing well.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.Additional information regarding treatment details were not provided.The recipient's issues have reportedly resolved.This is he 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: 9823976
• MDR Text Key: 183117714
• Report Number: 3006556115-2020-00123
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170424(17)200430
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2020; 04/28/2020; 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention