Description of Event or Problem · 1
THIS INFO TALKS ABOUT A SURGICAL PROCEDURE RESULTING IN THE RE-USING OF A RECALLED #6949 SPRINT FIDELIS LEAD WIRE DURING A PACEMAKER/DEFIBRILLATOR (P/D) REPLACEMENT PROCEDURE PERFORMED ON A (B)(6) SENIOR ON (B)(6) 2011. FIRST, ON (B)(6) 2007 THE MEDTRONIC, CO INC WARNED PTS VIA A LETTER THAT THE LEAD WIRE REFERRED TO COULD FRACTURE AND CAUSE INJURY. AT THE SAME TIME, THE COMPANY INFORMED DOCTORS THAT THE WIRE SHOULD BE REMOVED FROM SHELVES, AND ANY UNUSED WIRES SHOULD BE RETURNED TO THE COMPANY. THE OPINION IS THAT THIS PUBLIC NOTICE AND INSTRUCTIONS IS COMPATIBLE TO BEING A CEASE AND DESIST ORDER. PLEASE NOTE: ON 01/24/2012, I CONTACTED THE MEDTRONIC CO'S PATIENT SERVICES DEPT IN INTEREST OF COMMENTS CONCERNING THE SURGEON'S DECISION TO CONNECT THE RE-CALLED LEAD WIRE IN QUESTION. THE REPRESENTATIVE SPOKEN TO INFORMED ME THAT THE WIRE SHOULD "NOT BE USED." SHE ADDED THAT IT WAS THE "DOCTOR'S DECISION TO CONNECT THE WIRE." SHE REFUSED TO COMMENT TO FURTHER QUESTIONING. ON 01/25/2012, I AGAIN CONTACTED THE MEDTRONIC CO AND REQUESTED WRITTEN DOCUMENTATION CONFIRMING THE REPRESENTATIVE'S STATEMENT. IN RESPONSE, I RECEIVED CONFLICTING INFO VIA AN E-MAIL STATING THAT THE MEDTRONIC CO WOULD NOT RECOMMEND REPLACING THE RECALLED LEAD WIRE IF IT WAS FOUND TO BE FUNCTIONING PROPERLY. THE OPINION IS THAT THIS MEDTRONIC CO FORMAL STATEMENT ENCOURAGES DOCTORS TO UNJUSTLY CAUSE THE PT TO BE AN INVOLUNTARY SUBJECT OF EMOTIONAL ABUSE, AND AT THE PROLONGED MERCY OF AN UNPREDICTABLE POTENTIALLY HARMFUL "RE-USED" MEDICAL DEVICE. HAVING SAID THIS, I ALSO CONTACTED THE SURGEON'S OFFICE TO QUESTION WHY HE ATTACHED AND RE-USED THE RECALLED WIRE, HIS REPLY VIA AN E-MAIL WAS THAT "THE WIRE SEEMED TO BE FUNCTIONING APPROPRIATE," THERE IS NO NEED TO RISK PLACING ANOTHER. DISAPPOINTING IS THE FACT THAT DURING A PRE-OP CONSULTATION, NEITHER THE DOCTOR NOR THE MEDTRONIC CO REP BOTHERED TO INFORM THAT THERE WAS THE POSSIBILITY THE RECALLED FIDELIS LEAD WIRE "MAY BE RE-ATTACHED" TO THE NEW P/D DURING THE TRANSPLANT PROCEDURE AT THE DOCTOR'S DISCRETION. FOLLOWING THE IMPLANT REPLACEMENT SURGERY, AND DURING A FOLLOW-UP VISIT TO THE DOCTOR'S OFFICE, THE DOCTOR AND THE MEDTRONIC CO REP AGAIN FAILED TO COMMUNICATE AND INFORM ME OF THE FACT THAT THE QUESTIONABLE RE-CALLED FIDELIS LEAD WIRE "HAS BEEN ATTACHED" TO THE NEW P/D. NEEDLESS TO SAY, THIS TWO PARTY LACK OF COMMUNICATION VIOLATED MY RIGHT TO BE INFORMED, CONSIDER OPTIONS, AND CAUSED ME TO EXPERIENCE A FALSE SENSE OF RELIEF WHILE ASSUMING THAT THE POTENTIALLY HARMFUL RECALLED LEAD WIRE WAS DE-ACTIVATED AND "CAPPED" IN POSITION. INCIDENTLY, MEDICAL RECORDS AFTER (B)(6) 2007 WILL CONFIRM THAT I WAS HOSPITALIZED AND TREATED AFTER EXPERIENCING THREE INDIVIDUAL HEART ATTACKS FOLLOWING THE 2007 P/D IMPLANT PROCEDURE. IN FACT, THE FIRST HEART ATTACK OCCURRED JUST THREE MONTHS AFTER THE DEVICE WAS IMPLANTED. TO MY KNOWLEDGE, IN ALL INCIDENTS THE P/D DID NOT GIVE INDICATION THAT A HEART ATTACK TOOK PLACE, NOR DID IT PRE-WARN, OR RECORD IN ANY WAY THAT NEGATIVE ACTIVITY TOOK PLACE, STATS RESULTING IN MIND PROVOKING AND INTERESTING EVALUATION, TO SAY THE LEAST. CONCERNED, DURING THE MOST RECENT DOCTOR OFFICE VISIT, AND STILL UNAWARE OF THE FACT THAT THE RECALLED LEAD WIRE WAS ATTACHED TO THE NEW DEVICE, I ASKED THE DOCTOR IF I WAS P/D DEPENDENT, TO MY SURPRISE, HIS ANSWER WAS "NO." NEEDLESS TO SAY, CONFUSION AND FRUSTRATION PREVAIL. FINALLY, CONSIDERING THE CONTINUOUSLY GROWING NUMBER OF INJURIES AND DEATHS ASSOCIATED WITH THIS RE-CALLED DEVICE, THE MEDTRONIC CO EXPERTS, AND THE FDA'S SUGGESTED "DO NOT REPLACE" DIRECTIVE HAS CAUSED A SURGEON TO SUBJECT ME TO A PERSONAL UNSOLICITED RISK OF INJURY AS A RESULT OF A COMPANY OWNED POTENTIALLY UNSAFE FOREIGN DEVICE BEING "RE-USED," AND ALLOWED TO REMAIN ACTIVATED IN MY BODY, CONTRARY TO MY PREFERABLE OPTION OF CAPPING. NOTE, DESPITE THE FACT THAT I ATTEMPTED TO SEEK LEGAL GUIDANCE ON SEVERAL OCCASIONS CONCERNING THIS MATTER, TO NO AVAIL, THE INTENTION IS NOT TO DE-FAME ANY INDIVIDUAL AND/OR ORGANIZATION, NOR IS PURSUING COMPENSATION FOR DETERMINED WRONGS OR INFRACTIONS A FACTOR AT THIS TIME. THE OBJECTIVE IS TO SHARE A SITUATION CONSIDERED AS BEING PREVENTABLE, PENDING EVALUATION AND INITIATED CORRECTIVE MEASURES ENFORCED BY THOSE IN AUTHORITY.