BIPOLAR PACING 5F FD RH OUS

Additional Manufacturer Narrative

UDI INFORMATION (D4) AND 510K (G3) ARE NOT PROVIDED WITHIN THIS REPORT AS THIS PRODUCT (MODEL 401623) IS AN OUS CONFIGURATION NOT AVAILABLE IN THE US AND IS THEREFORE NOT REFERENCED IN THE GUDID DATABASE.

Description of Event or Problem

DURING AN IMPLANT PROCEDURE, IMMEDIATELY AFTER INSERTION OF THE LEFT VENTRICULAR (LV) WIRE INTO THE LEFT VENTRICLE, THE PATIENT'S INTRINSIC RHYTHM SLOWED AND PROGRESSED TO COMPLETE ATRIOVENTRICULAR BLOCK (CAVB). FOR UNKNOWN REASONS, THE PACING CATHETER DID NOT ACTIVATE, RESULTING IN TRANSIENT CARDIAC ARREST. THE NAVITOR VALVE WAS SUCCESSFULLY DEPLOYED WITHOUT COMPLICATIONS; HOWEVER, THE CAVB PERSISTED POSTOPERATIVELY. A MICRA DEVICE WAS IMPLANTED AND THE PATIENT STABILIZED. THE PATIENT'S HOSPITALIZATION WAS EXTENDED FOR CARDIAC RHYTHM MONITORING. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H2 H3, H6, H11 THE REPORTED EVENT WAS FOR HEART BLOCK. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.