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

Model Number CI-1500-04

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Numbness (2415)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient is reportedly experiencing swelling and numbness at the implant site with and without device use.Revision surgery is under consideration.

Manufacturer Narrative

The recipient's device was explanted.

Manufacturer Narrative

(b)(4).The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented one of the electrical tests from being performed.The device passed all of the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's surgical site is completely healed.This is the final report.

• Brand Name: HIRES 90K¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: pamela campo ; 28515 westinghouse place; valencia, CA 91355 ; 6613627624
• MDR Report Key: 5685466
• MDR Text Key: 46113920
• Report Number: 3006556115-2016-00228
• Device Sequence Number: 1
• Product Code: MCM
• 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: Audiologist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2014
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2013
• 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: 40 YR