3-T SYSTEM
Received Jun 21, 2007 · Event occurred Jun 15, 2007
Report MW5002806 · MDR key 871347
Device
Generic name
Mri
Manufacturer
Siemen's CorporationProduct problems
- Unknown (for use when the device problem is not known)
Patient
YR
- Twitching
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PATIENT SEDATED AND SLEEPING. THE DIFFUSION SEQUENCE WAS A 12 DIRECTION DTI APPLIED AT THE END OF THE PROTOCOL. SHORTLY AFTER, THE DIFFUSION GRADIENTS WERE APPLIED, THE CHILD'S ARMS AND LEGS BEGAN TO VISIBLY TWITCH, FOLLOWED SHORTLY BY ARM MOVEMENTS. THE SEQUENCE WAS ABORTED. THE CHILD WAS NOT AWAKENED BY THE SCAN. NO ADDITIONAL SEDATION WAS ADMINISTERED. AFTER WAITING APPROXIMATELY 30-45 SECONDS, A 3-DIRECTION, I.E. DWI-ONE PORTION OF THE DIFFUSION SEQUENCE WAS RUN. IN THIS INSTANCE, NO DISCERNABLE INVOLUNTARY MOVEMENT WAS OBSERVED NOR WAS THE CHILD AWAKENED BY THE SCAN. DATES OF USE: ONE DAY IN 2007. DIAGNOSIS OR REASON FOR USE: MRI OF BRAIN. EVENT ABATED AFTER USE STOPPED: YES.