FDA.reportPublic FDA data

MAUDE MDR 9880105

MDR report key
9880105
Report number
3002648230-2020-00174
Event key
0
Event type
3
Date of event
2020-01-07
Date received
2020-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PAULA BIXBY
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCTIC FRONT ADVANCE PRO? CARDIAC CRYOABLATION CATHETERPERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATIONMEDTRONIC CRYOCATH LPOAEAFAPRO28AFAPRO2815741Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-250

Event Narratives#

No narrative records found.