Description of Event or Problem · 0
CALLER REPORTING VARIABLE RV CAPTURE MANAGENT TRENDS RANGING FROM 0.75V TO 2.5 V AT 0.4 MS. AMPLITUDE AND PULSE WIDTH HAVE AYTO ADJUSTED TO AS HIGH AS SV@O. 76 MS. IN CLINIC MEASUREMENTS WERE REFLECTIVE OF CHRONIC MANUAL MEASUREMENTS OF [email protected]. CALLER CONCERNED THAT D/T H,C OF DEPENDANCY TURNING OFF AUTO CAP AND SETTING TO LOWER FIXED VOLTAGE COULD BE UNSAFE FOR THE PATIENT BUT ALSO EXPRESSED CONCERNE ABOUT HAVING TO CHANGE OUT THE DEVICE EARLY D/T UNNECESSARY BATTERY DEPLEATION FROM UNRELIABLE AUTO CAP TRENDS. BATTERY RANGE FROM (B)(6) 2021 CLE TRANSMISSION WASLESS THAN 4 - 18 MONTHS. TODAY WAS LESS THAN 2 MONTHS MINIMUM. NOTED ON SOME OF THE STORED MARKER CHANNELS VS EVENTS THAT COULD POSSIBLE BY OVERSENSING. RECOMMENDED SHE DISCUSS FINDINGS WITH PHYSICIAN FOR PROGRAMMING RECOMMENDATIONS AND CONSIDER BRINGING THE PATIENT BACK IN ONE MONTH TO REASSESS LEAD FUNCTION. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).