3-T SYSTEM
Received Jun 21, 2007 · Event occurred Jun 13, 2007
Report MW5002808 · MDR key 871352
Device
Manufacturer
Siemen's CorporationProduct problems
- Unknown (for use when the device problem is not known)
Patient
YR
- Twitching
Narrative
Description of Event or Problem
CHILD WAS SEDATED AND SLEEPING. THE DIFFUSION SEQUENCE WAS A 12-DIRECTION DTI PERFORMED IMMEDIATELY AFTER THE LOCALIZERS AT THE BEGINNING OF THE PROTOCOL. APPROXIMATELY HALF-WAY INTO THE SEQUENCE, SHORTLY AFTER THE DIFFUSION GRADIENTS WERE APPLIED, THE CHILD'S ARMS AND LEG BEGAN TO VISIBLY TWITCH, FOLLOWED BY FULL FLAILING OF THE ARMS, DISLODGING THE PULSE OXIMETER. THE DTI SCAN WAS ABORTED AND SERVICE REP DID A SAVELOG BEFORE THE PROTOCOL WAS CONTINUED. AFTER THE CHILD WAS RE-SEDATED, 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 OR DOSE REDUCED: YES.