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

Model Number CI-1600-04

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Swelling (2091)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

Udi number: ((b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient's swelling and infection resolved.This is the final report.

Event Description

The recipient reportedly experienced an infection at the implant site.The recipient presented with postauricular swelling with purulent drainage and fever.The recipient was hospitalized on (b)(6) 2017 for 1 week.On (b)(6) 2017, the recipient underwent an incision, drainage, and washout of the wound.The recipient was treated with iv antibiotics (clindamycin and rocephin) for 4 weeks and oral antibiotics for several weeks thereafter.The recipient was recommended non-use of the device from (b)(6) 2017.

• 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 ; 6613624711
• MDR Report Key: 6995186
• MDR Text Key: 90835300
• Report Number: 3006556115-2017-00595
• 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
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 6 YR