PATCH

Additional Manufacturer Narrative

AS OF TODAY, ALL AVAILABLE INFORMATION INDICATES THAT THIS LEAD REMAINS IN SERVICE. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT UNDERWENT A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) STUDY TO ASSES THE SYSTEM. THIS RESULTED IN A 56 OHM SHOCK IMPEDANCE MEASUREMENT. THE SYSTEM WILL CONTINUE TO BE MONITORED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS EPICARDIAL PATCH LEAD AND THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED HEARING TONES. TECHNICAL SERVICES (TS) DISCUSSED USING LATITUDE TO PERFORM AN INTERROGATION TO CHECK FOR THE SOURCE OF TONES. LATITUDE INDICATED THAT A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT HAD OCCURRED. TS RECOMMENDED BRINGING THE PATIENT IN FOR FURTHER EVALUATION. THE PATIENT WAS BROUGHT IN TO THE CLINIC FOR FOLLOW UP. THE LOCAL FIELD REPRESENTATIVE (FR) REPORTED THAT THEY WERE UNABLE TO REPRODUCE ANY PROBLEMS. THE PLAN WAS TO INCREASE CHECKS TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.