FDA.reportPublic FDA data

MAUDE MDR 9392539

MDR report key
9392539
Report number
2938836-2019-16775
Event key
0
Event type
3
Date of event
2019-11-19
Date received
2019-11-30
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
ELIZABETH BOLTZ
Address
15900 VALLEY VIEW COURT SYLMAR CA 91342 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORDEFIBRILLATION LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)NVY7122Q/65A000078235R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-3001. R

Event Narratives#

No narrative records found.