FDA.reportPublic FDA data

MAUDE MDR 9392506

MDR report key
9392506
Report number
2938836-2019-16770
Event key
0
Event type
3
Date of event
2019-11-11
Date received
2019-11-30
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
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
1UNIFY ASSURA CRT-D RF HVIMPLANTABLE CARDIOVERTER DEFIBRILLATORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)NIKCD3357-40QCD3357-40QA000076899R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-300

Event Narratives#

No narrative records found.