TRANSCRANIAL MAGNECTIC STIMULATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-30 for TRANSCRANIAL MAGNECTIC STIMULATION manufactured by Neurostar.

Event Text Entries

[3936741] I had a consultation with md, o(b)(6) to go over brain scans and to prepare to start tms (transcranial magnetic stimulation) the following monday. Doctor (b)(6) said that this treatment would significantly reduce the chronic headache pain that i have had for over five years. He said that the treatment itself may be uncomfortable but there were no side effect except in regards to that some patients experience seizures. On day two of the tms treatment the pain of the treatment areas were just about unbearable. The staff ordered me some numbing cream for those areas to help. The numbing cream did little to help over the next few treatments, and to add to this i started developing a new headache that wakes me up in the night and early morning with severe pain. This headache is much worse than my daily chronic headaches that i have been dealing with for years. I told the staff that i was feeling very irritated and had an angry feeling that i have never had before. After the staff spoke to dr (b)(6) they said they had been treating the wrong side of my head for one of the treatment areas and that they did not know why i was having headaches. On day 8 of the treatment day my husband called and cancelled the rest of our treatments and told (b)(6), office manager how bad my head pain had become due to these treatments. As of today on (b)(6), we have never heard from (b)(6). I am sure i am not the only pt that has had this happen to them and i find it in great concern that a fda approved medical device therapy can cause this kind of pain on a person. I am praying that these serious new headaches will go away soon, as they are debilitating.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5032509
MDR Report Key3453106
Date Received2013-10-30
Date of Report2013-10-29
Date of Event2013-10-07
Date Added to Maude2013-11-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRANSCRANIAL MAGNECTIC STIMULATION
Generic NameTRANSCRANIAL MAGNECTIC STIMULATION
Product CodeOBP
Date Received2013-10-30
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerNEUROSTAR


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-10-30

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