UNKNOWN TEMPORARY PACING ELECTRODE

Description of Event or Problem

IT WAS REPORTED BY THE CRITICAL CARE NURSES IN AN ONLINE SURVEY STATED THAT NO, THE TEMPORARY PACING ELECTRODE (TPE) CATHETER COULD NOT BE SUCCESSFULLY PLACED BECAUSE TECHNICALLY DIFFICULTIES DURING INSERTION IN RELATION TO SEMI-FLOATING TPE, MENTIONED THAT THE DEVICE WAS USED FOR 0 DAYS. ADDITIONALLY IN CHART 2 A PHYSICIAN STATED THAT NO, THE TEMPORARY PACING ELECTRODE (TPE) CATHETER WAS NOT ABLE TO SUCCESSFULLY CAPTURE AND PACE FOR THE CHOSEN DURATION OF USE BECAUSE TECHNICAL DIFFICULTIES IN RELATION TO SEMI-FLOATING TPE, MENTIONING THAT THE DEVICE WAS USED FOR 0 DAYS.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.