GAMMA CORE DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for GAMMA CORE DEVICE manufactured by Unk.

Event Text Entries

[128862316] I took my son ((b)(6)) to the neurologist this past monday for a check up and med review. While there, the dr decided to try the gamma core device on him stating it would either help or not. If it helped he would get us the paperwork needed to get one. My son was seated on the exam table and the nurse put 30 secs on the device and put some gel on the device and put it to my son's neck / jawline. He stated that it felt really weird and asked, could they do it with him laying down. The nurse went and asked the dr and came back into the room and said yes he could. The dr was not present during this new procedure, by the way. My son had just laid down, stated he felt weird then his whole body seized up, eyes rolled back in his head and was unresponsive for approx 1 to 2 mins. He finally responded to me for may be 1 min, then started to seize up again with eyes rolling back and unresponsive for another min or two. He had never had a seizure before, the squad was called and we were sent to the er. They drew blood, did ct scan and gave him fluid but came back with no answers as to what happened. His neurologist said anxiety attack but my son says absolutely not. He has had panic attacks before and this wasn't even close. He said he was coming in and out of consciousness, and felt like he was dying. So i am writing to you in hopes that you might have answers or helpful info as to what happened. Everything i read about this device is that it's completely safe and non evasive. Going to a neurologist as soon as possible for an eeg but need answers as to what happened. No one seems to know.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081676
MDR Report Key8111082
Date Received2018-11-27
Date of Report2018-11-26
Date of Event2018-11-19
Date Added to Maude2018-11-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGAMMA CORE DEVICE
Generic NameNON - INVASIVE VAGUS NERVE STIMULATOR - HEADACHE
Product CodeQAK
Date Received2018-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-27

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