FDA.reportPublic FDA data

MAUDE MDR 557589

MDR report key
557589
Report number
1067103-2004-00016
Event key
0
Event type
3
Date of event
2004-10-29
Date received
2004-12-01
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
2555 MARCONI DRIVE SUITE 220 ALPHARETTA GA 30005 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GLIASITE RADIATION THERAPY SYSTEM (RTS)MANUAL RADIONUCLIDE APPLICATOR SYSTEMPROXIMA THERAPEUTICS, INC.KXK*1040M21697YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-12-0101. R

Event Narratives#

D

Patient 1

THE BALLOON WAS POSITIONED IN THE PORTION OF THE CAVITY WHERE THE TUMOR HAD RECURRED POST RESECTION. AFTER SURGERY, PT PRESENTED WITH SYMPTOMS THAT WERE RELATED TO PRESSURE ON THE BRAIN. THESE SYMPTOMS INCLUDED SLOW TO WAKE UP POST ANESTHESIA, SPEECH IMPAIRMENT, AND INABILITY TO STAY AWAKE. THE PT DID NOT RECEIVE BRACHYTHERAPY.