FDA.reportPublic FDA data

MAUDE MDR 3629038

MDR report key
3629038
Report number
3005188751-2014-00010
Event key
0
Event type
3
Date of event
2014-01-10
Date received
2014-01-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DENISE JOHNSON, RN
Address
177 EAST COUNTRY ROAD B ST. PAUL MN 55117 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REFLEXION CATHETERST. JUDE MEDICAL, INC. (AF-MINNETONKA)HCCUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-2701. R

Event Narratives#

D

Patient 1

RELATED MANUFACTURER REFERENCE 3005188751-2014-00007, 3005188751-2014-00008, 3005188751-2014-00009. AFTER THE COMPLETION OF A CARDIAC ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. ONCE ALL DEVICES HAD BEEN REMOVED, THE PATIENT COMPLAINED OF DISCOMFORT AND BECAME HYPOTENSIVE. A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

N

Patient 1

METHOD: THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO REC'D, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN INHERENT RISK DURING THE USE OF THIS DEVICE IN THE HEART.