Description of Event or Problem · 1
IT WAS REPORTED BY A VNS PT THAT SHE FELT DIZZY WITH STIMULATION. ALSO, SHE INDICATED SHE HAD A PAIN IN THE BACK OF HER HEAD AND HER VNS LEAD HAD BEEN IMPLANTED OVER A GOITER THAT SHE HAD, SO THE LEAD WAS NOW PROTRUDING. FOLLOW-UP WAS OBTAINED FROM THE PT'S PHYSICIAN'S OFFICE AND THEY STATED THE PT DID NOT INDEED GET DIZZY WITH STIMULATION; HOWEVER, THE PAIN'S RELATIONSHIP TO VNS WAS NOT KNOWN. THE DEVICE HAD BEEN "CHECKED" AND THE DOCTOR'S NOTES INDICATED "PROPER DEVICE FUNCTION", ALTHOUGH NO SPECIFICS WERE AVAILABLE. THE SITE STATED THAT THE LEAD WAS "NOT PROTRUDING PER SE", BUT THAT THE DOCTOR COULD PALPATE THE WIRES IN THE PT'S NECK, AND "EVERYTHING SEEMED TO BE LOCATED WHERE IT SHOULD BE". THE PT WAS TO UNDERGO A CT SCAN ANGIOGRAM TO INVESTIGATE THE DIZZINESS AND PAIN FURTHER, BUT THE DOCTOR DID NOT INDICATE THAT THIS WAS TO PRECLUDE A SERIOUS INJURY. NO CHANGES WERE MADE TO THE PT'S SETTINGS PRECEDING THE ONSET OF THE EVENTS, AND NO CHANGES HAD BEEN MADE WHEN THE DEVICE WAS CHECKED. HOWEVER, LATER INFO WAS GIVEN TO A COMPANY REP STATING THE PT WAS REFERRED TO A SURGEON AS SHE HAD A LEAD THAT WAS PROTRUDING DUE TO THE GOITER. THE SURGEON'S NURSE INDICATED THAT THE PT MAY BE EXPLANTED WITH NO REPLACEMENT. THE PT SUBSEQUENTLY UNDERWENT A REPLACEMENT SURGERY WHERE HER GENERATOR WAS EXPLANTED. IT WAS NOT DECIDED IF THE LEAD WOULD BE REPLACED YET. FURTHERMORE, IT WAS STATED THAT THE ISSUE WAS THE PT'S TIE-DOWN. DURING THE SURGERY, THE SURGEON REMOVED ONE TIE-DOWN AND REPLACED THE GENERATOR AS THERE WAS "NO ISSUE WITH THE LEAD AT THIS TIME". GOOD FAITH ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.