3-T SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-21 for 3-T SYSTEM manufactured by Siemen's Corporation.

Event Text Entries

[21715562] Mri of the brain, the diffusion sequence was a 12 direction dti applied immediately following localizers at the beginning of the protocol. The dti sequence was run under the guidance of the attending neuroradiologist. The child was sedated and sleeping. Approximately half way into the sequence, shortly after the diffusion gradients were applied, the child's arms and legs began to visibly twitch followed by full flailing of the arms and dislodging of the pulse oximeter. The tech aborted the sequence when instructed by the physician. The patient was assessed and reported to still be sedated and sleeping. No additional sedation was administered. The protocol was continued without the dti. A 3-direction i. E. Dwi was applied at the end of the protocol. In this instance, there were no discernable involuntary movement observed nor was the child awakened by the scan. Date of use: one day in 2007. Diagnosis or reason for use: mri of the brain. Event abated after use stopped: yes. Event reappeared after reintroduction: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5002807
MDR Report Key871350
Date Received2007-06-21
Date of Report2007-06-21
Date of Event2007-06-17
Date Added to Maude2007-07-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name3-T SYSTEM
Product CodeMRI
Date Received2007-06-21
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key855373
ManufacturerSIEMEN'S CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2007-06-21

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