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

Model Number CI-1600-04

Device Problem Extrusion (2934)

Patient Problem Unspecified Infection (1930)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The recipient reportedly experienced device extrusion due to a bilateral otitis media infection.The recipient presented with pus.The recipient's device was explanted.The recipient will not be reimplanted at this time.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was reportedly not explanted.The recipient underwent a mastoid washout and had the wound closed with some tissue advancement.The recipient has healed and is wearing the device.This is the final report.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355 ; 6613621741
• MDR Report Key: 7570238
• MDR Text Key: 110109566
• Report Number: 3006556115-2018-00235
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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: 56 YR