Description of Event or Problem · 0
THIS PACING SYSTEM ANALYZER (PSA) IS NOTED FROM A CALL PLACED TO TECHNICAL SERVICES WHICH STATES THAT THE REP IS STARTING TO SEE THIS ISSUE ON A MORE FREQUENT BASIS. THE PHYSICIAN PUT THE LEAD DOWN AND HOOKED UP THE CONNECTOR TOOL AND THE PACING SYSTEM ANALYZER (PSA). THEN THEY WOULD GO TO MAP THEY WOULD GET NOISE ON THE PACING SYSTEM ANALYZER (PSA). THE REP STATED THAT THE MEDTRONIC PACING SYSTEM ANALYZER (PSA) HAD NOISE WHEN TRYING TO MAP. IT WAS NOT ABLE TO MEASURE A-WAVES DUE TO THE NOISE. VISUALLY THEY THOUGHT IT WAS IN A GOOD SPOT AND SCREWED OUT. SOME NOISE AFTER THE HELIX WAS DEPLOYED BUT ABLE TO MEASURE A-WAVE AND THAT WAS WITH THE MEDTRONIC PACING SYSTEM ANALYZER (PSA). THRESHOLD AND IMPEDANCE WERE MEASURED WITH THE MEDTRONIC PACING SYSTEM ANALYZER (PSA) THEN MOVED BACK TO ANOTHER PACING SYSTEM ANALYZER (PSA) AND STILL BASELINE NOISE BUT WAS ABLE TO MEASURE A-WAVES, IMPEDANCES AND THRESHOLD. DR. (B)(6) DID NOT EXERCISE THE HELIX BEFORE IMPLANT AND IT COULD BE THAT IS THE REASON. DR. (B)(6) THEN ASKED MAYBE THE HELIX IS NOT FAR OUT ENOUGH TO MAP? ARE WE GETTING ANY OTHER REPORTS ABOUT HELIX FAR OUT ENOUGH TO MAP. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) MEDICAL CENTER. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).