PATCH
Received Apr 5, 2012 · Event occurred Jan 10, 2012
Report 2124215-2012-01855 · MDR key 2518955
Device
Product problems
- Insufficient Device Problem Information
Patient
64 YR
- Perforation of Vessels
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ELECTIVE REMOVAL OF THIS LEAD WITH A NON BOSON SCIENTIFIC EXTRACTION LASER, A PERFORATION OCCURRED IN THE SUPERIOR VENA CAVA. THE PERFORATION WAS ATTRIBUTED TO THE LASER. AS A RESULT THE PATIENT NEEDED TO UNDER GO AND EMERGENCY STERNOTOMY TO CONTROL THE BLEEDING. THE BLEEDING GOT UNDER CONTROL AND THE PHYSICIAN COMPLETED THE PROCEDURE. THERE WEAR NO ALLEGATIONS OF BOSTON SCIENTIFIC PRODUCT MALFUNCTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.