FDA.reportPublic FDA data

MAUDE MDR 9392093

MDR report key
9392093
Report number
2017865-2019-17247
Event key
0
Event type
3
Date of event
2019-11-08
Date received
2019-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1CD2257-40 FORTIFY ASSURA DR ICD_IDE_USIMPLANTABLE CARDIOVERTER DEFIBRILLATORST. JUDE MEDICAL, INC.(CRM-SYLMAR)NVZCD2257-404358938R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-290

Event Narratives#

No narrative records found.