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 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Udi # (b)(4).

Event Description

The recipient reportedly underwent an mri procedure with the internal magnet in place due to medical reasons unrelated to the device.The recipient's internal magnet was displaced.The recipient's internal magnet was replaced.The recipient is reportedly using the device.

Manufacturer Narrative

On january 11, 2017, the company received the internal magnet.

Manufacturer Narrative

(b)(4).Correction: date of event.The magnet passed the visual inspection.The magnet passed the gauss measurement test.The magnet passed the tests performed.No corrective action is indicated.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: 6125333
• MDR Text Key: 60843597
• Report Number: 3006556115-2016-00493
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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: 60 YR