Description of Event or Problem · 1
ACCORDING TO SOMETHING PT'S CARDIOLOGIST TOLD FAMILY MEMBER, IT SOUND LIKE THE WRONG LEAD WAS USED FOR PT - PROBABLY DUE TO PT'S BLOOD CONDITION, MYELOPROLIFERATIVE DISORDER - POLYCYTHEMIA VERA A THREADED TYPE SHOULD NOT HAVE BEEN USED. ALSO, PT'S LEFT JUGULAR VEIN WAS CLOGGED SO THEIR PACEMAKER WAS INSTALLED ON THE RIGHT SIDE. AFTER THIS PT STARTED FORMING BLOOD CLOTS. APPARENTLY PT'S LEAD WAS A THREADED TYPE WHICH MAY HAVE CAUSED THE CLOTS. IT CAUSED THEIR BATTERY TO BE USED EXTENSIVELY WHICH WOULD HAVE MEANT HAVING IT REPLACED IN ABOUT TWO YEARS VS THE NORMAL LIFE SPAN OF A PACEMAKER BATTERY. PT REFUSED ALL FURTHER SURGERY WHICH OF COURSE WAS THE ULTIMATE REASON PT DIED WHEN AND HOW THEY DID. THEIR PACEMAKER WAS A GUIDANT #MODEL 1283 AND THE LEAD-S - ALSO GUIDANT (WHICH WERE THE CAUSE OF THE PROBLEM) WERE MODEL 4463 AND MODEL 4464. FAMILY MEMBER IS NOT TRYING TO CAUSE ANY PROBLEMS, BUT FAMILY MEMBER IS TRYING TO FIND OUT WHO CHOSE THE TYPE OF LEADS TO BE USED FOR EACH SITUATION. FAMILY MEMBER CALLED THE MFR AND THE LADY FAMILY MEMBER SPOKE TO DIDN'T KNOW. PROBABLY MORE IMPORTANTLY, IN FAMILY MEMBER'S MIND, IS TO GET THE INFO RECORDED SO THAT IT BECOMES KNOWN. DOES FDA DO THIS? IF NOT, PLEASE GET THIS INFO TO THE RIGHT AGENCY. FAMILY MEMBER HAS BEEN TRYING TO DO THIS FOR YEARS AND THIS IS THEIR FINAL ATTEMPT.