Description of Event or Problem · 1
A VNS THERAPY PHYSICIAN REPORTED THAT DURING A PATIENT'S LAST FOLLOW UP APPOINTMENT ((B)(6) 2009), A PROGRAMMING/DIAGNOSTIC SESSION RESULTED IN A BATTERY LONGEVITY PROJECTION OF 10 YEARS REMAINING AT 1.25 MA AND "STANDARD PARAMETERS" (PATIENT IMPLANTED (B)(6) 2009). DURING THE PATIENT'S RECENT FOLLOW UP VISIT ((B)(6) 2011) A DEVICE INTERROGATION WITH VERSION 8.0 SOFTWARE RESULTED IN AN UNEXPECTED "INTENSIFIED FOLLOW-UP INDICATOR (IFI) =YES" NOTIFICATION, WHICH IS TRIGGERED AT MEASURED BATTERY VOLTAGES BELOW 2.8 V. THE ALERT IS MEANT TO SERVE AS A NOTIFICATION TO THE TREATING PHYSICIAN THAT THE GENERATOR BATTERY WAS MEASURED TO BE AT A LEVEL WHERE MORE FREQUENT CLINICAL MONITORING IS RECOMMENDED. BASED ON REPORTED PATIENT SETTINGS AND IMPLANT DURATION (2 YEARS), THE APPARENT MEASURED BATTERY VOLTAGE APPEARS TO BE UNCHARACTERISTICALLY LOW. THE PHYSICIAN INDICATED THAT AS A RESULT OF THE NOTIFICATION, HE HAS ELECTED TO FOLLOW UP WITH THE PATIENT MORE FREQUENTLY AS SUGGESTED BY THE IFI NOTIFICATION. NO SERIOUS PATIENT INJURY HAS BEEN REPORTED IN RELATION TO THIS EVENT AND THE PATIENT'S VNS REMAINS PROGRAMMED ON AND FUNCTIONAL. NO SURGERY IS PLANNED AT THIS TIME. A REVIEW OF THE DEVICE'S DHR REVEALED THAT ALL ELECTRICAL TESTS/VISUAL INSPECTIONS WERE PASSED PRIOR TO DEVICE SHIPMENT AND THAT THE VOLTAGE MEASUREMENT ACCURACY OF THE GENERATOR WAS NEAR THE LOWER LIMIT OF THE SPECIFICATION, WHICH MAY EXPLAIN THE LOWER MEASURED VOLTAGE VALUE. NO FURTHER PROGRAMMING HISTORY WILL BE PROVIDED FROM THE SITE FOR REVIEW THAT WOULD BE NEEDED TO EVALUATE THE CAUSE OF THE REPORTED EVENT.