MAUDE MDR 5758226

MDR report key
5758226
Report number
MW5063149
Event key
0
Event type
3
Date of event
2016-06-17
Date received
2016-06-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEUROSTAR TMS THERAPYNEUROSTAR TMS THERAPYNEURONETICS INC.OBP* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-2401. R; 2. S

Event Narratives#

D

Patient 1

DID TRANSCRANIAL MAGNETIC STIMULATION. THIS IS A NEW PROCEDURE THAT USES MAGNETIC PULSES ON THE BRAIN TO HELP DEPRESSION. SUPPOSED TO DO 30 SESSION 5 DAYS A WEEK FOR ABOUT 45 MINUTES. ALL THE RESEARCH SAYS THE ONLY SIDE EFFECTS ARE MILD SCALP IRRITATION AND HEADACHE WHERE THE MAGNETIC TOUCH THE HEAD. AFTER A FEW DAYS OF DOING IT, I FELT SICK, NAUSEA, AND MY DEPRESSION BECAME EXTREMELY WORSE. I QUESTIONED THE DOCTOR WHO SAID THIS DOESN'T HAPPEN, NEVER HEARD OF DEPRESSION GETTING WORSE. WE KEPT GOING AND BY THE 20TH SESSION I WAS SO SICK AND DEPRESSED. I HAD TO STOP. PLUS IT BECAME SO ACTIVATED, I COULD NOT SLEEP. I WAS ON NO MEDICATIONS PRIOR TO DOING THIS. I HAD TO GET AN EMERGENCY VISIT TO A PSYCHIATRIST WHO PUT ME ON ANTIDEPRESSANTS TO THIS DAY AREN'T HELPING. I CAN NO LONGER TAKE A MED. THE DEPRESSION IS TOO SEVERE CAUSING ME TO HARDLY BE ABLE TO MOVE MY BODY. I HAVE CHRONIC PAIN ALL OVER MY BODY. I CAN NO LONGER DO THINGS I USED TO BE ABLE TO DO. THIS PROCEDURE RUINED MY LIFE.