FDA.reportPublic FDA data

MAUDE MDR 9391642

MDR report key
9391642
Report number
3008973940-2019-03204
Event key
0
Event type
3
Date of event
2019-11-01
Date received
2019-11-29
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
1CAPSUREFIX NOVUS LEAD MRI SURESCANELECTRODE, PACEMAKER, PERMANENTMEDTRONIC SINGAPORE OPERATIONSDTB5076-585076-58* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. R

Event Narratives#

No narrative records found.