MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K ADVANTAGE IMPLANT; COCHLEAR IMPLANT

Model Number CI-1500-01

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erythema (1840); Unspecified Infection (1930); Perforation (2001); Swelling (2091)

Event Date 04/07/2016

Event Type  Injury  

Event Description

The recipient reportedly is experiencing an infection.The infection is not device related.On (b)(6) 2016, the recipient received conservative treatment due to the redness from the increased magnet strength.On (b)(6) 2016, the recipient underwent wound debridement of the skin flap.The recipient's infection resolved.On (b)(6) 2019, the recipient's infection recurred and the recipient underwent skin flap revision surgery.The recipient then presented with swelling at the implant site, and on (b)(6) 2019, the recipient underwent skin flap revision surgery.The infection resolved, however, recurred again, in (b)(6) 2020.Following the recurrence, the recipient experienced skin perforation and device extrusion.On (b)(6) 2020, the recipient's device was explanted.The recipient was not reimplanted at this time.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's infection reportedly 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 external visual inspection revealed the electrode had damaged and exposed wires.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires.This is believed to have occurred during revision surgery.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 90K ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9826087
• MDR Text Key: 183251337
• Report Number: 3006556115-2020-00133
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)150724(17)170731
• 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,Followup,Followup,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR