NBIH¿ Temporary Pacing Electrode Catheter

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE NO DEPTH MARKERS ON TEMPORARY PACING ELECTRODE WITH ITEM CODE 007153P, ON A COLLEAGUES DEMO PACK OF THE SAME ITEM CODE THERE WAS DEPTH MARKERS ON HER ITEM CODE SO BELIEVED THERE SHOULD BE DEPTH MARKERS FOR SAFETY WHEN PLACING THE WIRES.