FDA.reportPublic FDA data

MAUDE MDR 7330339

MDR report key
7330339
Report number
MW5075783
Event key
0
Event type
3
Date of event
2017-10-18
Date received
2018-03-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FOCUSED MAGNETIC ULTRASOUND FOR CENTRAL TREMORSMR-GUIDED FOCUSED ULTRASOUND SYSTEMINSIGHTEC, LTD.POHI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-0901. O

Event Narratives#

D

Patient 1

REPORTER ALLEGES SHE HAD FOCUSED ULTRASOUND ON THE LEFT SIDE OF HER BRAIN TO DECREASE TREMORS ON HER RIGHT HAND. THIS PROCEDURE WAS DONE AT (B)(6) HOSPITAL IN (B)(6) WHERE SHE HAD TO PAY $(B)(4) UPFRONT. ALLEGEDLY, SHE WAS TOLD THE PROCEDURE IS PAINLESS AND ITS AN IN AND OUT PROCEDURE, NOT ONLY DID SHE EXPERIENCE EXCRUCIATING PAIN SHE ALSO HAD AN OVERNIGHT STAY FOR OBSERVATION. SHE ALSO FELT IGNORED WHEN SHE WAS IN DISTRESS AND IT FELT LIKE SHE WAS IN A TORTURE CHAMBER. REPORTER BELIEVES THE PROCEDURE WAS HIGHLY UNSUCCESSFUL AND EXPENSIVE FOR SOMETHING THAT DID NOT WORK FOR HER. SHE ALLEGES HER TREMORS HAVE GOTTEN WORSE, SHE WAS INCOHERENT AFTER THE PROCEDURE, HER SCALP HURTS AND SHE HAS DIZZY SPELLS.