FDA.reportPublic FDA data

MAUDE MDR 9903120

MDR report key
9903120
Report number
2029046-2020-00502
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. GABRIEL ALFAGEME
Address
31 TECHNOLOGY DRIVE IRVINE CA 92618 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMOCOOL? SMART TOUCH? SF BI-DIRECTIONAL NAVIGATION CATHETERCARDIAC ABLATION PERCUTANEOUS CATHETERBIOSENSE WEBSTER INCLPBD134805D134805N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. L; 2. R

Event Narratives#

No narrative records found.