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

Model Number CI-1500-01

Device Problem Nonstandard Device (1420)

Patient Problems Erythema (1840); Skin Irritation (2076); Ulceration (2116); Pressure Sores (2326); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

The recipient reportedly experienced redness, skin irritation, and a pressure ulcer at the implant site due to the magnet strength of the external equipment.The recipient reportedly has a thin skin flap.The recipient was treated with topic ointment and antibiotics.

Manufacturer Narrative

The recipient was prescribed antibiotics (keflex) for 7 days and recommended to discontinue using the device for one week.The infection and the ulceration have resolved.This is the final report.

• Brand Name: HIRES 90K ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342
• Manufacturer Contact: nicole birch, associate ; 12740 san fernando rd; sylmar, CA 91342 ; 6613621528
• MDR Report Key: 4873921
• MDR Text Key: 6048090
• Report Number: 3006556115-2015-00290
• 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,health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2012
• 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