FDA.reportPublic FDA data

MAUDE MDR 1543759

MDR report key
1543759
Report number
3003870001-2009-00016
Event key
0
Event type
3
Date of event
2009-11-10
Date received
2009-11-20
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
KAREN MCKELVEY
Address
ONE ST. JUDE MEDICAL DRIVE 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
1ULTRACINCH LP, 10 CELL, UC-LP-10ULTRACINCH LP, 10 CELLST. JUDE MEDICALNTBNA12545NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-11-2001. O

Event Narratives#

D

Patient 1

IT WAS REPORTED A ROUTINE ABLATION WAS COMPLETED, AND THE PATIENT IMMEDIATELY WENT ON PUMP TO DO THE PRIMARY SURGERY. THE PATIENT CAME OFF PUMP AFTER THE CONCLUSION OF THE CASE, AND WAS TAKEN TO THE RECOVERY ROOM. IN THE RECOVERY ROOM, THE STAFF NOTICED THE PATIENT WAS BLEEDING. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE 1 OR 2 THIN AREAS IN THE BACK OF THE HEART AND A SMALL OPENING / TEAR WERE REPAIRED. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AGAIN. THE PATIENT IS DOING FINE AND IS BACK IN SINUS RHYTHM. THE ST. JUDE MEDICAL REPRESENTATIVE STATED THE SURGEON AGREED TO HAVE A SURGEON, WHO IS A TRAINER JOIN HIM ON HIS NEXT EPICOR PROCEDURE TO SEE IF HE COULD OFFER ANY SUGGESTIONS. THE ST. JUDE MEDICAL REPRESENTATIVE WAS AT THE ACS THE ENTIRE TIME AND DID NOT SEE ANY ERROR MESSAGES.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED BLEEDING AND SUBSEQUENT SURGERIES COULD NOT BE DETERMINED. THE USER AGREED TO HAVE A SURGEON, WHO IS A TRAINER JOIN HIM ON HIS NEXT EPICOR PROCEDURE TO SEE IF HE COULD OFFER ANY SUGGESTIONS.