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

Model Number CI-1500-04

Device Problem Electromagnetic Interference (1194)

Patient Problem No Information (3190)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

Udi number: na.

Event Description

The company was informed that the recipient was near an mri machine with internal magnet in place.The recipient's internal magnet was displaced.Revision surgery is under consideration.

Manufacturer Narrative

The recipient's magnet was repositioned on (b)(6) 2015.The recipient is reportedly doing well.

Manufacturer Narrative

(b)(4).Advanced bionics received a copy of mdr # (b)(4) that was submitted regarding this event.Advanced bionics considers the investigation into this reportable event as closed.The recipient is reportedly doing well.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: 5192999
• MDR Text Key: 30020532
• Report Number: 3006556115-2015-00537
• 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
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2014
• Device Model Number: CI-1500-04
• 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: 08/31/2013
• 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: 37 YR