ELAN SRE-3050 PFR STAIRLIFT

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FELT A SHOCKING SENSATION WHEN THEY WERE SITTING IN A CHAIR THAT LIFTED THEM UP THE STAIRS AND THEN THEIR LEG WOULD BE BOTHERING THEM. AGENT REVIEWED THE STAIR LIFT POTENTIALLY COULD BE EMITTING EMI(ELECTROMAGNETIC INTERFERENCE) TO CAUSE THE ISSUES WITH THEIR SCS(SPINAL CORD STIMULATOR). CALLER STATES TODAY HE DISCOVERED WHILE CHECKING THE INTEGRITY OF THE SYSTEM THAT CONTACT 15 HAS IMPEDANCE ISSUE, NOTED SPECIFICALLY 0/15 SHOWS 20,150OHMS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE CAUSE OF THE SHOCKING WAS NOT DETERMINED. IT WAS STATED THAT THEY DO NOT KNOW THAT THE PATIENT DOES NOT EXPERIENCE ANY ELECTRICAL RESPONSES WHEN THEY SIT IN THE CHAIRLIFT CHAIR, BUT THEY DO FEEL SOME SORT OF INTERFERENCE WHEN THEY OPERATE THE CHAIRLIFT. THE SHOCKING SENSATION WAS RESOLVED AS LONG AS THE PATIENT DOES NOT USE THE STAIRLIFT. THIS HAS BEEN OCCURRING FOR 4-5 MONTHS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).