PATCH

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.

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS INVOLVED IN INFECTION. THE LEAD WAS DETACHED AND HAD BACTERIA ON IT. THE FIELD REPRESENTATIVE WAS NOT ABLE TO IDENTIFY WHAT HAD SPECIFICALLY DETACHED AMONG THE LEADS AFTER ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT WAS SURGICALLY ABANDONED.