PACEL BIPOLAR PACING CATHETER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

Description of Event or Problem

THIS PER IS INITIATED FROM AN ADVERSE INCIDENT REPORT SUBMITTED BY (B)(6) HOSPITAL DIRECTLY TO CHINA MEDICAL DEVICE AE REPORTING SYSTEM (HTTP://MAERS.ADRS.ORG.CN). THE SJM NOTIFIED WAS MADE AWARE ON (B)(6) 2025 FROM THE SYSTEM. PLEASE MAKE THIS A COMPLAINT PRODUCT SO A REGULATORY REPORT CAN BE SUBMITTED TO NMPA. THE PATIENT UNDERWENT TEMPORARY PACEMAKER IMPLANTATION FOR THIRD-DEGREE ATRIOVENTRICULAR BLOCK. A FOLLOW-UP EXAMINATION THE DAY AFTER SURGERY REVEALED SINUS RHYTHM, THIRD-DEGREE ATRIOVENTRICULAR BLOCK, AND PREMATURE VENTRICULAR BEATS. THE LEAD WAS FOUND TO BE DETACHED. THE PACING CATHETER WAS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT IS IN GOOD CONDITION AND HAS BEEN DISCHARGED. THE CAUSE MAY HAVE BEEN IMPROPER OPERATION OR PATIENT ACTIVITY, BUT NEITHER IS CERTAIN.