SMALL PATCH (SAME AS A67) 6.1 SUTURE UNI 67CM

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV LEAD DISPLAYED AN INCREASED SHOCK IMPEDANCE MEASUREMENT WITH A NEWLY IMPLANTED DEVICE. THE PHYSICIAN BELIEVED THAT ONE OF THE EPICARDIAL SHOCKING LEADS WAS FRACTURED. THE DEVICE WAS PROGRAMMED OFF AND THE PATIENT WAS WEARING A THERAPEUTIC LIFE VEST WHILE NEXT STEPS WERE BEING DETERMINED.

Additional Manufacturer Narrative

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem

BOSTON SCIENTIFIC CRM (BSC) RECEIVED INFORMATION FROM A HEALTH CARE PROVIDER (HCP) THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ASSOCIATED WITH A REPORT OF A REMOTE MONITORING ALERT FOR A HIGH SHOCK IMPEDANCE MEASUREMENT, AND THAT THE IMPEDANCE MEASUREMENT FROM THE PATIENT¿S LAST CLINICAL FOLLOW-UP WAS NORMAL. A BSC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT THE ALERT WAS FROM 5.7 MONTH PREVIOUS, AND TRIGGERED BECAUSE IT WAS THE FIRST DEVICE DATA DOWNLOAD TO THE REMOTE MONITORING SYSTEM. TS DISCUSSED THE NORMAL LEAD IMPEDANCE RANGE FOR THE LEAD AND ALERT, AND HOW TO CLEAR THE ALERT FROM THE SYSTEM. HCP ELECTED TO CONTINUE TO MONITOR THE PATIENT. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV DISPLAYED AN INCREASED SHOCK IMPEDANCE MEASUREMENT WITH THE NEWLY IMPLANTED DEVICE. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE.