FDA.reportPublic FDA data

MAUDE MDR 9903881

MDR report key
9903881
Report number
2017865-2020-04454
Event key
0
Event type
3
Date of event
2020-03-18
Date received
2020-03-31
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
1FORTIFY DR, U1.6 DF1 USIMPLANTABLE CARDIOVERTER DEFIBRILLATORST. JUDE MEDICAL, INC.(CRM-SYLMAR)NVZCD2231-40CD2231-403750932R 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. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED DUE TO PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS PERFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.