InjuryNHW
SYNCRUS HEART WIRE KIT
Received Jul 17, 2003 · Event occurred Jun 24, 2003
Report 2953148-2003-00716 · MDR key 472728
Device
Generic name
Defibrillator
Manufacturer
Guidant Cardiac SurgeryModel number
TX-3000Catalog number
TX-3000
Lot number
3032182
Product problems
- Unknown (for use when the device problem is not known)
Patient
NO INFO
- Dural Tear
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED THAT AFTER THE COMPLETION OF CORONARY ANASTOMOSIS, THE RIGHT ATRIAL CARDIOVERSION WIRE CAUSED TISSUE TEAR ON THE EPICARDIUM OF THE RIGHT ATRIAL APPENDAGE OF THE HEART. THE SURGEON USED SUTURES TO REPAIR THE TORN AREA. THE PROCEDURE WAS COMPLETED BY AFFIXING THE RIGHT ATRIAL CARDIOVERSION WIRE TO THE ATRIUM WITHOUT ANY ISSUES. NO ADDITIONAL PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.
Remedial action
- Other