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

Model Number CI-1500-01

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Fall (1848)

Event Date 11/19/2015

Event Type  Injury  

Event Description

The recipient reportedly experienced a fall causing edema at the implant site.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The company was informed that the explanted device was discarded and will not be returned to the company for analysis.A review of the device history record noted no rework.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: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 6119397
• MDR Text Key: 60621786
• Report Number: 3006556115-2016-00516
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: CI-1500-01
• 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: 12/31/2013
• 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: 7 YR