PATIENT CABLE

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT FOR A PATIENT WITH ATRIAL FIBRILLATION LEADING TO THE INITIATION OF A BETA-BLOCKER, THE PATIENT CABLE CONNECTING THE PACEMAKER CONTROL UNIT TO THE INTERNAL PACEMAKER'S EPICARDIAL ELECTRODES WAS IMPROPERLY INSERTED INTO THE INTERMEDIATE CONNECTOR. THIS IMPROPER CONNECTION RESULTED IN THE INTERNAL PACEMAKER FAILING TO CAPTURE, WHICH LED TO ASYSTOLE AND A SYNCOPAL EPISODE, FOLLOWED BY TWO CARDIAC ARRESTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.