Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT LOW IMPEDANCE HAD BEEN OBSERVED DURING A SYSTEM DIAGNOSTICS TEST. THE PT'S HEAD WAS REPOSITIONED MULTIPLE TIMES, AS STILL THE LOW IMPEDANCE DID NOT RESOLVE. X-RAYS WERE TAKEN, AND THE PT WAS REFERRED FOR SURGERY. THE PT HAD RECENTLY FLIPPED HIS WHEELCHAIR AND FALLEN ON THE LEFT SIDE OF HIS FACE, HOWEVER, IT IS UNK IF THE PHYSICIAN FEELS THAT THIS WAS RELATED TO THE LOW IMPEDANCE. THE PT WAS LAST SEEN IN (B)(6) AND THERE WAS NO REPORT OF LOW IMPEDANCE FROM THAT VISIT. IT WAS REPORTED THAT THE PT WAS NOT EXPERIENCING AN INCREASE IN SEIZURES AS A RESULT OF THE LOW IMPEDANCE, AND THE PT'S GENERATOR WAS LEFT PROGRAMMED ON, AS THE PHYSICIAN FELT THAT THE PT MAY STILL BE RECEIVING EFFICACY FROM THE DEVICE. THE PHYSICIAN IS AWARE OF THE MFR'S RECOMMENDATION TO DISABLE THE DEVICE WHEN LOW IMPEDANCE IS NOTED. A/P VIEWS OF THE NECK AND CHEST WERE REVIEWED FOR THE PT. THE GENERATOR PLACEMENT APPEARED TO BE NORMAL IN THE LEFT CHEST. THE FILTER FEEDTHRU WIRES WERE INTACT. IT APPEARED THAT THE LEAD PIN WAS FULLY INSERTED PAST THE CONNECTOR BLOCKS. THE ENTIRE LEAD COULD NOT BE SEEN IN THE X-RAY IMAGES AS A PORTION OF THE LEAD WAS COILED BEHIND THE GENERATOR. THERE DID NOT APPEAR TO BE ANY LEAD DISCONTINUITIES IN THE VISIBLE PORTIONS OF THE LEAD. TWO SUSPECT AREAS WERE IDENTIFIED. ONE AREA IN THE COILED PORTION OF THE LEAD, AND ANOTHER IN THE LEAD BODY BETWEEN THE GENERATOR AND THE ELECTRODES APPEAR QUESTIONABLE, HOWEVER, DUE TO IMAGE QUALITY, IT CANNOT BE DETERMINED IF A LEAD BREAK HAS OCCURRED. THEREFORE, A FRACTURE OR MICRO-FRACTURE CANNOT BE RULED OUT. BASED ON THE IMAGES PROVIDED, THERE DID NOT APPEAR TO BE AN OBVIOUS CAUSE FOR THE PT'S REPORTED LOW IMPEDANCE. HOWEVER, A LEAD BREAK IN THE SUSPECT AREAS OR NON-VISIBLE PORTION OF THE LEAD OR A MICRO-FRACTURE COULD NOT BE RULED OUT AS THE CAUSE. ADD'L INFO WAS RECEIVED INDICATING THAT THE PT UNDERWENT REVISION SURGERY. DURING THE PROCEDURE, THE OLD GENERATOR WAS REMOVED AND GENERATOR DIAGNOSTICS WERE PERFORMED INDICATING THAT IMPEDANCE IN THE GENERATOR WAS WITHIN NORMAL LIMITS. THIS GENERATOR WAS PROPHYLACTICALLY REPLACED, AND A NEW GENERATOR WAS IMPLANTED. DIAGNOSTICS WERE PERFORMED INDICATING THAT THE LOW IMPEDANCE STILL EXISTED. THE PT THEN UNDERWENT A FULL REVISION WITH LEAD REPLACEMENT. IT WAS NOTED, DURING THE EXPLANT OF THE LEAD THAT THE LEAD WAS SPLIT IN TWO HALFWAY UP. THE EXPLANTED LEAD AND GENERATOR HAVE SINCE BEEN SENT TO THE MFR FOR PRODUCT ANALYSIS; HOWEVER, ANALYSIS IS NOT YET COMPLETE.