Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT A PT'S VNS WAS REPLACED DUE TO END OF SERVICE. THE EXPLANTED GENERATOR WAS RETURNED AND PRODUCT ANALYSIS WAS COMPLETED. THE GENERATOR FAILED THE FEED-THRU CAPACITOR TESTS, BACKUP CAP POS TO CAN (-0.263V) AND BACKUP CAP NEG TO CAN (-1.041V), AS IT DID NOT COMPLY WITH SPECIFICATION LIMITS THAT ARE BETWEEN -3.3V AND -2.2V. THE GENERATOR MODULE WAS OPERATING WITHIN DESIGNED LIMITS, MEETING CYBERONICS POST-BURN ELECTRICAL TEST SPECIFICATIONS. REGARDING THE BACKUP ISSUE NOTED IN THE ABOVE PARAGRAPH, THE FUNCTION OF THE FEED-THRU CAPACITORS IS ONLY TO PROVIDE ELECTROMAGNETIC INTERFERENCE PROTECTION (IF THE NEED EVER ARISES) AND IS NOT REQUIRED TO PROVIDE THERAPY. AS A RESULT, AN INTERMITTENT ELECTRICAL CONNECTION OF THIS COMPONENT DOES NOT IMPEDE THE GENERATOR'S ABILITY TO PROVIDE THERAPY ACCORDING TO THE PROGRAMMED SETTINGS. FUNCTIONALLY, THE DEVICE WILL PERFORM AS INTENDED AND PROVIDE AN OUTPUT PULSE THAT MEETS SPECIFICATION. IT IS POSSIBLE THAT THE MANIPULATION OF THE FEED-THRU WIRES MAY HAVE CONTRIBUTED TO THE INTERMITTENT CONDITION OF THE DISCOIDAL CAPACITOR TO HAVE RESOLVED ON ITS OWN. THE GENERATOR WAS RE-ASSEMBLED AND PASSED CYBERONICS FINAL ELECTRICAL TEST SPECIFICATIONS. WITH THE EXCEPTION OF THE NOTED CONDITIONS, THERE WERE NO ADVERSE FINDINGS THAT WOULD INHIBIT THE GENERATOR FROM PERFORMING AS INTENDED. CYBERONICS, INC. (B) (4).