PACEL BIPOLAR PACING CATHETER

Description of Event or Problem

IT WAS REPORTED THAT DURING PACEMAKER IMPLANTATION PROCEDURE USING A PACEL FLOW DIRECTED PACING CATHETER, PACING FAILURE OCCURRED. ATTEMPTS WERE MADE TO RECONNECT THE PATIENT CABLE AND PERFORM OTHER TROUBLESHOOTING STEPS; HOWEVER, THE MALFUNCTION PERSISTED. AS A RESULT, THE DEVICE WAS WITHDRAWN FROM USE, AND ANOTHER UNKNOWN DEVICE WAS UTILIZED TO CONTINUE THE PROCEDURE WITHOUT ANY PATIENT CONSEQUENCES.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.