HELIX LOCKING TOOL

Description of Event or Problem

IT WAS REPORTED THAT THIS ACCESSORY HELIX LOCKING TOOL EXHIBITED LOOSENESS WITH THE INVOLVED LEAD DURING AN IMPLANT PROCEDURE RESULTING TO LEAD DISLODGEMENT. THE PATIENT HAD INFECTION WHICH WAS ATTRIBUTABLE TO THE UNDERLYING PATIENT CONDITION. THIS ACCESSORY WAS OUT OF SERVICE AND REPLACED WITH A NEW LOCKING TOOL RESULTING TO A COMPLETED PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Additional Manufacturer Narrative

THIS PRODUCT WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THE UDI REGULATION, SO THE COMPLETE UDI IS UNAVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.