FDA Adverse Event Injury Summary report: N

TRANSCRANIAL MAGNETIC STIMULATOR

MDR report key: 16462160 · Received February 28, 2023

Report

Report Number
MW5115352
Event Type
Injury
Date Received
February 28, 2023
Date of Event
January 18, 2022
Report Date
February 26, 2023
Manufacturer
UNK
Product Code
OBP
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

FOR TREATMENT RESISTANT DEPRESSION, I UNDERWENT A COMPLETE SERIES OF APPROXIMATELY 36 SESSION OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION TREATMENT AT (B)(6). TREATMENT WAS FROM (B)(6) 2021 TO (B)(6) 2022 . FOLLOWING THE RTMS (REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION) I EXPERIENCED A SIGNIFICANT LOSS OF HEARING AND A NEW EXPERIENCE OF TINNITUS IN MY LEFT EAR. I HAD PRE EXISTING HEARING LOSS BUT IT WORSENED CONSIDERABLY AFTER THE TREATMENT. I WORE EAR PUGS FOR EVERY SESSION. HOWEVER, AS I LATER LEARNED, IT HAS BEEN LONG RECOGNIZED THAT BOTH AIR CONDUCTION (AC) AND BONE CONDUCTION (BC) ARE BOTH MAJOR MEDIATORS FOR SOUND TO THE INNER EAR. NOT ONLY IS THERE A LOUD SOUND WITH RTMS BUT ALSO A VERY STRONG VIBRATION. I WAS NOT SCREENED PROPERLY. THERE ARE PREVIOUS STUDIES THAT RECOMMENDED , AMONG OTHER ISSUES, SAFETY SCREENING FOR POTENTIAL HEARING ISSUES RELATED TO AGE, PRE-EXISTING HEARING LOSS AND TINNITUS. AT THE TIME OF TREATMENT I WAS 74 YEARS OLD, AND HAD PRE-EXISTING HEARING LOSS AND TINNITUS. PRIOR TO TREATMENT THERE WAS NO CONSULTATION RECOMMENDED WITH MY AUDIOLOGIST/ENT (EAR, NOSE, THROAT) PHYSICIAN. I HAVE THE RESULTS OF TWO RECENT AUDIOGRAMS-ONE BEFORE TMS AND ANOTHER AFTER TMS TO DOCUMENT THE LOSS. FOLLOWING TREATMENT, I REACHED OUT TO DR. (B)(6) AT (B)(6) AND ADVISED HIM OF THE PROBLEM AND RECOMMENDED BETTER SCREENING. HE WAS SYMPATHETIC AND FELT THAT THE ISSUE SHOULD RECEIVE NATIONAL ATTENTION. PLEASE ADVISE PROVIDERS OF THE EXISTING SAFETY CHECKLISTS (EARLIER RESEARCH RECOMMENDATIONS)) AND INCLUDE THE HIGHER RISK FACTORS OF ADVANCED AGE AND PREEXISTING HEARING LOSS. IT MAY ALSO BE ADVISABLE TO INVESTIGATE VIA FMRI HOW THE LOUD NOISE AC(AIR CONDUCTION) AND VIBRATIONS BC(BONE CONDUCTION) FROM TMS MAY CONSTITUTE A CRUCIAL PROBLEM. REQUIRE SAFETY SCREENING CHECKLIST OF ALL PROVIDERS SO IT CAN BE DOCUMENTED IN MEDICAL FILE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1913834 TRANSCRANIAL MAGNETIC STIMULATOR TRANSCRANIAL MAGNETIC STIMULATOR OBP UNK

Patients

Seq Age Sex Outcome Treatment
1 75 YR Male Disability| O COENZYME Q10| KENALOG CREAM| MAGNESIUM| PROZAC| SILDENAFIL| VITAMIN D3| VOLTAREN GEL| ZINC