FDA.reportPublic FDA data

MAUDE MDR 9908634

MDR report key
9908634
Report number
2017865-2020-04504
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
1FORTIFY ASSURA VR ICD, USIMPLANTABLE CARDIOVERTER DEFIBRILLATORST. JUDE MEDICAL, INC.(CRM-SYLMAR)LWSCD1357-40QCD1357-40Q4634953R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

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. THE DEVICE IS INCLUDED IN THE BATTERY PERFORMANCE ALERT ADVISORY ISSUED BY ABBOTT ON 28 AUGUST 2017.

D

Patient 1

FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. PATIENT WAS STABLE POST PROCEDURE.