FDA Adverse Event Injury Summary report: N

.5 TESLA SHORT BORE MRI SYSTEM, YEAR MANUFACTURED 2006

MDR report key: 20291117 · Received September 20, 2024

Report

Report Number
MW5159960
Event Type
Injury
Date Received
September 20, 2024
Date of Event
August 5, 2024
Report Date
September 19, 2024
Manufacturer
GE HEALTHCARE MANUFACTURING LLC.
Product Code
LNH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2024, I HAD AN MRI OF THE LUMBAR SPINE DONE AT (B)(6). BY MIDDAY I DEVELOPED HUMMING IN MY EARS THAT HAS NOT GONE AWAY. IT APPEARS TO BE PRIMARILY THE LEFT EAR. A FEW DAYS LATER I ALSO NOTICED FULLNESS AND PRESSURE IN THE LEFT EAR AND FACE. I WENT TO MY ENT ON (B)(6) 2024. A HEARING TEST WAS DONE AND I WAS FOUND TO HAVE HEARING LOSS AT THE HIGHER FREQUENCIES. MY ENT SAID I DO NOT NEED A HEARING AID YET AND THAT THE HUMMING MAY BE PERMANENT. I HAD A FOLLOW UP VISIT WITH HIM ON (B)(6) 2024. BOTH TIMES THERE WAS NO SIGN OF AN INFECTION, TOO MUCH EAR WAX, OR DAMAGE TO THE EARS. (B)(6) PUT EAR PLUGS IN BOTH MY EARS AS WELL AS USING SOUND REDUCING HEADPHONES. I HAVE HAD AT LEAST 9 MRIS IN THE PAST AND NEVER HAD ANY ISSUES. I AM ALSO GETTING SOME PERIODIC CRACKLING IN BOTH EARS. I HAVE TO TURN UP THE VOLUME ON MY TV, ALL CHANNELS. IF I HAD HEARING LOSS BEFORE, I WAS NOT AWARE OF IT. I HAD NOT HAD A HEARING TEST FOR MANY YEARS. I ALSO WENT TO MY DENTIST. I HAVE SOME TMJ (TEMPOROMANDIBULAR JOINTS) ISSUES AND GOT A NIGHTGUARD BUT HE DOES NOT THINK MY TMJ IS THAT SEVERE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1243530 .5 TESLA SHORT BORE MRI SYSTEM, YEAR MANUFACTURED 2006 SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC. EXITE HD

Patients

Seq Age Sex Outcome Treatment
1 73 YR Female Disability AVALIDE 150-12.5 MG TABLET (DAILY ONE TABLET).| OMEPRAZOLE 20 MG CAPSULE (ONCE DAILY).| ONE CENTRUM ADULT MULTIVITAMIN TABLET.| ONE VITAMIN D 2000 IU SOFT GELATIN CAPSULE DAILY. | SIMVASTATIN 20 & 40 MG TABLETS (ALTERNATE DOSES TO AVERAGE 30 MG DAILY DOSE). | SYNTHROID 50 MCG TABLET (MONDAY TO SAT).| VITAMIN D CHEWY (3 PER DAY).| VITOFUSION CALCIUM (3 PER DAY).