BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER

Additional Manufacturer Narrative

INITIAL REPORTER ADDRESS: (B)(6). 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 DURING THE PACEMAKER IMPLANTATION PROCEDURE, THE INITIALLY USED TEMPORARY PACING ELECTRODE LEAD DID NOT SUPPORT THE PROCEDURE AS SATISFACTORY POSITIONING AND PACING PARAMETERS COULD NOT BE ACHIEVED. THE LEAD WAS REPLACED WITH ANOTHER PACING LEAD, WHICH FUNCTIONED PROPERLY AND ALLOWED SUCCESSFUL COMPLETION OF THE PROCEDURE. HENCE, THE INITIALLY USED PACING LEAD WAS CONSIDERED FAULTY. THE LEAD WAS INSERTED IN THE PATIENT AND THEN TAKEN OUT WHEN THE PATIENT WAS EXPOSED TO BODILY FLUID.