MAUDE Adverse Event Report: COCHLEAR BAHA/ ATTRACT; HEARING IMPLANT

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

I have a baha (bone anchored hearing aid).This device is surgically implanted in the skull and has a magnet under the scalp.The "safety card" that i carry i supposed to provide information on mri's.The mri has to be set at certain settings or i could be seriously injured and or suffer fatal injuries.The card supplied is terrible and i've complained by e-mail to the company, cochlear, several times to no avail.They are headquartered in (b)(4) but have a facility in (b)(4).I'm concerned that if i were in an emergency situation and unable to tell medical facility about the magnet, there is absolutely no way anyone would give this card a second look.Is there anything your agency can do to remedy this?.

• Brand Name: BAHA/ ATTRACT
• Type of Device: HEARING IMPLANT
• Manufacturer (Section D): COCHLEAR
• MDR Report Key: 6145223
• MDR Text Key: 61517799
• Report Number: MW5066526
• Device Sequence Number: 1
• Product Code: LXB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR