FDA.reportPublic FDA data

MAUDE MDR 9601216

MDR report key
9601216
Report number
9601216
Event key
0
Event type
3
Date of event
2019-11-06
Date received
2020-01-17
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TREXFULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPHNATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)GWQ* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-170

Event Narratives#

D

Patient 1

PATIENT FELT THAT THE A-EEG EQUIPMENT MAY HAVE BEEN FREQUENTLY BUT NOT CONSTANTLY INTERFERING WITH HIS PM-DEFIBRILLATOR DEVICE. THE A-EEG BATTERIES AND ELECTRODES WERE REMOVED AND PATIENT STATED THE PROBLEM "SEEMED" TO STOP. THERE ARE NO COMPLAINTS WHEN THE A-EEG EQUIPMENT WAS CONNECTED TO HIM IN THE LAB. THERE IS NO KNOWN HARM TO THE PATIENT.