FDA.reportPublic FDA data

MAUDE MDR 9908391

MDR report key
9908391
Report number
2017865-2020-04494
Event key
0
Event type
3
Date received
2020-03-31
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
1QUADRA ASSURA CRT-D QUAD RF HVIMPLANTABLE CARDIOVERTER DEFIBRILLATORST. JUDE MEDICAL, INC.(CRM-SYLMAR)NIKCD3365-40QCD3365-40Q4344431R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP VVI. THE DEVICE WAS REPROGRAMMED. PATIENT WAS IN STABLE CONDITION.