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

Model Number CI-1600-04

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 07/09/2018

Event Type  Injury  

Event Description

The recipient is reportedly experiencing lock issues.The recipient underwent debridement surgery, however, the issue did not resolve.On (b)(6) 2018, the recipient underwent a another debridement surgery.The recipient is being monitored.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly underwent the original debridement surgery on (b)(6) 2018, followed by another on (b)(6) 2018.The final debridement surgery occurred on (b)(6) 2018.The recipient's wound and lock issues have both resolved.This is the final report.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection reportedly resolved.This is the final report.

Manufacturer Narrative

The recipient's wound was reportedly managed medically until (b)(6) 2018.On (b)(6) 2018, the recipient's device was reportedly explanted due to wound breakdown, device extrusion, and an infection.The recipient was not reimplanted.The external visual inspection revealed the electrode was severed along the lead 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 completed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 7857864
• MDR Text Key: 119639099
• Report Number: 3006556115-2018-00432
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)180118(17)210131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR