Description of Event or Problem · 1
A PATIENT WAS BEING TREATED WITH DBS. A MAPPING CATHETER WAS USED TO ELICIT THE PART OF THE BRAIN WHICH RESPONDED BEST TO THE STIMULATION FROM THE CATHETER. THIS CATHETER IS USED WITH A SPECIFIC GENERATOR. THEN, THAT CATHETER WAS REMOVED, AND THE DBS CATHETER MODEL #3387 STIMULATING ELECTRODE WAS PUT IN PLACE IN THE BRAIN (THIS IS CONNECTED TO A DIFFERENT GENERATOR). WHEN STIMULATION WAS APPLIED TO THE ELECTRODE, IT DID NOT FUNCTION. SEVERAL DIFFERENT PLACEMENTS OF THE CATHETER WERE TRIED, WITH NO STIMULATION RESULTING. THE GENERATOR IS NOT BELIEVED TO BE THE PROBLEM - IT WAS USED IN ANOTHER PROCEDURE ABOUT A WEEK AFTER THIS ONE, AND THE GENERATOR AND CATHETER WORKED WELL. THE NON-FUNCTIONING CATHETER WAS REMOVED AND THE PATIENT DID NOT RECEIVE A CATHETER. UPON INSPECTION, FLUID WAS NOTED IN THE CATHETER, NEAR THE ELECTRODES. SOME OF THE FLUID DRIED OVERNIGHT, BUT A SMALL AMOUNT REMAINED IN THE CATHETER. THE CATHETER WAS SENT TO MEDTRONIC FOR TESTING. MEDTRONIC PERFORMED SOME TESTING OF THE PRODUCT AND FOUND NO PROBLEM WITH THE CATHETER, BUT THE SITE IS ASKING THE COMPANY TO RE-EVALUATE THE CATHETER AND EXTEND THE TEST TO CONSIST OF SENDING A SIGNAL THROUGH THE CATHETER AND READING THE AMOUNT OF OUTPUT AND WAVEFORM PRODUCED. THE SITE BELIEVES THAT A SMALL BREECH IN THE INSULATION OF THE ELECTRODES WOULD NOT HAVE BEEN DETECTED BY THE TESTING PERFORMED BY THE COMPANY. THE SITE ALSO QUESTIONED WHY THERE WAS FLUID IN THE CATHETER, AND THE COMPANY RESPONDED THAT THE DESIGN IS ONE WITH AN OPEN LUMEN, SO IT IS NOT UNEXPECTED THAT FLUID WOULD INGRESS INTO THE CATHETER. THE COMPANY STATES THAT THE INSULATED ELECTRODES WERE PROTECTED AND WOULD NOT SHORT OUT.