FDA.reportPublic FDA data

MAUDE MDR 8649946

MDR report key
8649946
Report number
2017865-2019-08805
Event key
0
Event type
3
Date of event
2019-05-21
Date received
2019-05-29
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
Phone
818-818-8184
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1QUICKFLEX MICRO LV LEADPERMANENT PACEMAKER ELECTRODEST. JUDE MEDICAL, INC.(CRM-SYLMAR)OJX1258T/863678292R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-290

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 RECEIVED A VIBRATORY ALERT. IT WAS NOTED THAT PACING IMPEDANCE WAS BELOW THE NORMAL RANGE AND NOISE REPRODUCIBLE WITH ISOMETRIC TESTING WAS OBSERVED ON THE LEFT VENTRICULAR LEAD. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS TO CONTINUE WITH MONITORING AND WAS STABLE.