FDA.reportPublic FDA data

MAUDE MDR 3172544

MDR report key
3172544
Report number
9612186-2013-00004
Event key
0
Event type
3
Date of event
2013-05-17
Date received
2013-06-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
LINAC HOUSE FLEMMING WAY CRAWLEY, WEST SUSSEX RH10 UK
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEKSELL GAMMA KNIFE 4CSYSTEM, RADIATION THERAPY, RADIONUCLIDE,ELEKTA INSTRUMENT ABIWBY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-1701. O

Event Narratives#

D

Patient 1

A PATIENT WAS UNDERGOING A SECOND GAMMA KNIFE TREATMENT ON (B)(6) 2013 WHEN THE TREATMENT WAS DELIVERED TO THE WRONG SIDE OF THE BRAIN.

N

Patient 1

THE INVESTIGATION INTO THIS INCIDENT IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETE, ELEKTA WILL FORWARD ADDITIONAL INFORMATION TO THE FDA.

N

Patient 1

THE MANUFACTURER'S INVESTIGATION CONCLUDED THAT IT WAS APPARENT THAT THE PLAN AND THE VERIFICATION WERE COMPLETED INCORRECTLY BY THE RESPONSIBLE CLINICIANS. THE EQUIPMENT PERFORMED AS INTENDED DURING PLANNING AND TREATMENT. PLEASE NOTE THAT THIS IS THE FINAL REPORT.