FDA Adverse Event Malfunction Summary report: N

BONEBRIDGE

MDR report key: 18150741 · Received November 15, 2023

Report

Report Number
MW5148192
Event Type
Malfunction
Date Received
November 15, 2023
Date of Event
November 9, 2023
Report Date
November 10, 2023
Manufacturer
MED EL / MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
Product Code
PFO
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAVE GRAVES' DISEASE AND THYROID EYE DISEASE. MY ENDOCRINOLOGIST ORDERED AN OCULAR MRI. WHEN I SPOKE WITH THE LEAD TECHNICIAN AT THE UNIVERSITY OF (B)(6) RADIOLOGY DEPARTMENT, SHE TOLD ME THAT THEY HAVE FOUND THAT RECIPIENTS OF THE MED EL BONEBRIDGE DEVICE ARE RESULTING WITH ALMOST COMPLETELY UNUSABLE MRI HEAD IMAGES DUE TO ARTIFACT. I RECEIVED A BONEBRIDGE DEVICE IN 2022. THE MODEL IS BCI 602. THE INFORMATION AVAILABLE AT THE TIME WAS THAT IT WAS MRI COMPATIBLE UP TO 1.5 T. I HAVE HAD A KNEE MRI, SUBSEQUENTLY AND I DID NOT HAVE A PROBLEM. THE TECHNICAL INFORMATION WAS THAT THERE WOULD BE ARTIFACT UP TO 16 CM FROM THE IMPLANT USING CERTAIN ARTIFACT SUPPRESSION TECHNIQUES. IT TURNS OUT FROM SPEAKING WITH THE TECHNOLOGIST THAT IS A GROSS UNDERSTATEMENT. SHE SAID SHE SPOKE WITH A REP FROM THAT COMPANY WHO ADMITTED THAT THE ARTIFACT SUPPRESSION TECHNIQUES WERE BASED ON RESEARCH DONE ON ORTHOPEDIC IMPLANTS, AND WERE IN FACT NOT PROVEN IN THESE DEVICES. WE ARE NOT SURE YET IF I'M STILL GOING TO HAVE THE MRI AND HOPE FOR A MINIMAL AMOUNT OF USEFUL DATA OR IF I WILL HAVE TO HAVE A ORBITAL CT WHICH WILL NOT GIVE OPTIMAL INFORMATION, I WILL ALSO HAVE TO BE EXPOSED TO RADIATION. IT STILL IS UP IN THE AIR WHETHER OR NOT, I WILL HAVE TO HAVE THIS REMOVED IN MY BEST INTEREST, MEDICAL WISE. I FEEL LIKE I WAS SOLD A PRODUCT AND IT IS NOT AS IT WAS PURPORTED TO BE. IF I HAVE TO HAVE THIS REMOVED TO OBTAIN ADEQUATE MEDICAL CARE, IF SO I WILL SUFFER TANGIBLE PHYSICAL HARM. OBVIOUSLY THAT HAS NOT HAPPENED YET, BUT THE FACT I AM HAVING TO MAKE DECISIONS LIKE THAT ARE INEXCUSABLE. I HAVE INCLUDED PHOTOS OF THE INFORMATION CARD, WHICH WAS PROVIDED TO ME TO GIVE TO MRI TECHNICIANS AND AN IMAGE I DOWNLOADED FROM THE INTERNET THAT SHOWS YOU WHAT THE DEVICE IS. IT IS UNDER MY SKIN AND SCREWED INTO MY SKULL SO THE ONE I HAVE IS AN IMAGE I DOWNLOADED FROM THE INTERNET THAT SHOWS YOU WHAT THE DEVICE IS. IT IS UNDER MY SKIN AND SCREWED INTO MY SKULL SO THE ONE I HAVE IS OBVIOUSLY NOT VISIBLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
912676 BONEBRIDGE ACTIVE IMPLANTABLE BONE CONDUCTION HEARING SYSTEM PFO MED EL / MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH BCI 602

Patients

Seq Age Sex Outcome Treatment
1 56 YR Female Other