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

Model Number HIRES 90K

Device Problems Electromagnetic Interference (1194); Malposition of Device (2616)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/30/2015

Event Type  malfunction  

Event Description

Patient with bilateral cochlear implants was scheduled for a cardiac mri.The implants were researched through our normal process beginning with (b)(6).That website led us to the manufacturer's website which stated that the implants identified by the patient were safe to be in a 1.5t scanner.He was in the room less than 2 minutes and about four feet from the scanner when he indicated that he did not feel right.He was immediately removed from the room.It has been confirmed by an outside ent provider that the patient's cochlear implant magnet had shifted requiring a minor procedure.Unknown how long the cochlear implants had been in place prior to the mri.The patient had not removed the components of the device prior to entering the mri room.The cochlear implants were fully intact.

• Brand Name: HIRES 90K
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 28515 westinghouse pl; valencia CA 91355
• MDR Report Key: 5350017
• MDR Text Key: 35213188
• Report Number: 5350017
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: HIRES 90K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 36 YR