FDA.reportPublic FDA data

MAUDE MDR 9903857

MDR report key
9903857
Report number
2017865-2020-04449
Event key
0
Event type
3
Date of event
2019-11-11
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1QUARTET LEAD DOUBLE BEND, 86 CMPERMANENT PACEMAKER ELECTRODEST. JUDE MEDICAL, INC.(CRM-SYLMAR)OJX1457Q/861457Q/86A000046960R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3120881. D

Event Narratives#

N

Patient 1

THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. 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

RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-04445, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-04451, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-04453. IT WAS REPORTED THAT THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS CARDIAC AND PULMONARY ARREST.