FDA.reportPublic FDA data

MAUDE MDR 9860823

MDR report key
9860823
Report number
2134265-2020-03587
Event key
0
Event type
3
Date of event
2020-02-28
Date received
2020-03-20
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
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEMSYSTEM, APPENDAGE CLOSURE, LEFT ATRIALBOSTON SCIENTIFIC CORPORATIONNGVR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLEEDING EVENT. IT WAS REPORTED VIA SOCIAL MEDIA THAT DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE INVOLVING A WATCHMAN DEVICE, "THE PATIENT ALMOST BLED OUT ON THE TABLE AND THAT THEY ARE TAKING IRON INFUSION AND B12 INJECTIONS."