Description of Event or Problem · 0
THIS RA LEAD WAS IMPLANTED ON (B)(6) 2000, AND REMAINS IMPLANTED AT THIS TIME. A CALL WAS PLACED TO TECHNICAL SERVICES ON (B)(6) 2018, STATING THAT THIS LEAD WAS EXHIBITING NOISE AND OVERSENSING. IT WAS REPORTED, THAT THE PATIENT WAS HOSPITALIZED, DUE TO A SYNCOPAL EVENT. IMPEDANCE MEASUREMENTS ARE STABLE AND DEVICE PACES ABOUT 2% OF THE TIME. IT WAS ALSO NOTED, THAT WHEN USING HIGHER OUTPUTS, WHILE DOING THE THRESHOLDS DID CAUSE COUGHING TO THE PATIENT, WHICH WAS A BIT ODD. ASSUMING THAT THE LEADS ARE IN NORMAL LOCATIONS. A POSSIBILITY OF PERFORMING ISOMETRICS WAS DISCUSSED, BUT IT MAY BE TOO AGGRESSIVE ON THE OLD LEADS. THE FOLLOWING PHYSICIAN WAS DR. (B)(6). NO OTHER INFORMATION IS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).