BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 384145 · Received March 20, 2002

    Report

    Report Number
    MW4003220
    Event Type
    Death
    Date Received
    March 20, 2002
    Date of Event
    September 25, 2001
    Report Date
    March 20, 2002
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    RPTR JUST READ ABOUT THE POSSIBILITY FOR MORE USAGE OF THE IMPLANTED INTERNAL HEART DIFIBRILLATOR. SPOUSE WAS IMPLANTED WITH A MEDTRONIC DEVICE LAST SUMMER AFTER A HEART ATTACK THAT HAD DESTROYED MOST OF HEART. RPTR NOW BELIEVED THAT SPOUSE WAS NOT A CANDIDATE FOR SUCH A DEVICE DUE TO THE AMOUNT OF DAMAGE HEART HAD. THE SPOUSE WAS PUT ON HOSPICE AND IT WAS NOT TURNED OFF. IT WENT OFF AT LEAST 44 TIMES BEFORE THEY COULD GET THE DR TO GET THE MEDTRONIC PEOPLE OUT TO DEACTIVATE IT. SPOUSE DIED AND NOW RPTR AND FAMILY MEMBER ARE UNDERGOING NOT ONLY THE GRIEF PROCESS BUT MENTAL ANXIETY FROM WHAT THEY WENT THROUGH FROM THE USAGE OF THIS DEVICE. SPOUSE NOT ONLY HAD THE HEART DAMAGE BUT ALSO HAD SEVERE LUNG DISEASE. THE RISKS AND RESULTS OF THE USAGE OF SUCH DEVICE WAS NOT PROPERLY EXPLAINED TO THEM. SPOUSE WAS MENTALLY UNABLE TO MAKE CHOICES BUT THE DR HAD THEM SIGN A RELEASE FOR THE PROCEDURE EVEN AFTER. BEING AWARE OF THEIR CONFUSION DURING THIS TIME, RPTR BELIEVED SPOUSE WAS USED AS AN EXPERIMENT. PLEASE SET MORE RIGID GUIDELINES FOR THIS SO OTHER FAMILIES WILL NOT HAVE TO GO THROUGH WHAT THEY DID. THE HOSPICE NURSE IN CHARGE HAD DIFFICULTY IN GETTING ANSWERS AND HELP WITH THIS PROBLEM.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM RPTR 4/8/02: THE RPTR STATED THAT THE DEVICE WAS IMPLANTED IN PT WHO WAS IN THE ICU WITH A HISTORY OF A MASSIVE HEART ATTACK AND WAS HOSPITALIZED WITH PVCS AND IRREGULAR HEART BEAT. THE DECISION WAS MADE TO IMPLANT THE DEVICE BY THE PHYSICIAN AFTER THE PT WAS DEFIBRILLATED TWICE IN THE ICU AND KEPT REVERTING TO THE PREVIOUS IRREGULAR RHYTHM. THE RPTR STATED THAT THE PT HAD A DNR ORDER ON FILE AT THE TIME AND WAS INCOHERENT WHEN THEY HAD PT TO SIGN THE CONSENT TO IMPLANTED THE DEVICE. RPTR ALSO STATED THAT THEY HAD THE POWER OF ATTORNEY AT THE TIME BUT THEY WERE NOT CONSULTED WHEN THE DECISION WAS MADE TO IMPLANT. AFTER THE PT WAS IMPLANTED WITH THE DEVICE THEY WERE DISCHARGED HOME WITH HOME HEALTH CARE ON JULY 29TH. ON AUGUST 25, THE DEVICE STARTED FIRING A NUMBER OF TIMES SO THE PT WAS TAKEN BACK TO THE HOSP. PT WAS THEN DIAGNOSED WITH ARRHYTHMIA. WHEN THEY FURTHER EVALUATED THE PT, THEY DETERMINED THAT THE PT'S HEART HAD STOPPED THREE TIMES. THE PT WAS THEN GIVEN A POOR PROGNOSIS AND WAS SENT HOME ON HOSPICE CARE, BUT THE DEVICE REMAINED IMPLANTED AND WAS NOT DEACTIVATED. RPTR FURTHER STATED THAT THE WEEK BEFORE THE PT DIED, THE DEVICE FIRED SO MANY TIMES AND SO STRONGLY THAT WHEN ANYONE TOUCHED THE PT, THEY WOULD BE SHOCKED WITHOUT WARNING. IN ONE INSTANCE, A FAMILY MEMBER WAS LITERALLY KNOCKED DOWN DUE TO THE SHOCKS. THE SHOCKING GOT SO BAD THAT THE HOSPICE NURSE HAD TO CALL UP THE PHYSICIAN IN ORDER TO BE ADVISED HOW TO DEACTIVATE THE DEVICE. HOSPICE NURSE WAS TOLD TO TRY USING A MAGNET. THE MAGNET HAD TO BE TAPED TO THE PT'S CHEST UNTIL A TECH FROM MEDTRONIC CAME TO DEACTIVATE THE DEVICE. THE TECH DETERMINED THAT THE DEVICE WENT OFF 44 TIMES. RPTR DOES NOT FEEL THAT THE PT WAS A GOOD CANDIDATE FOR THE DEVICE, AND THAT PT SUFFERED UNNECESSARY DISCOMFORT BECAUSE OF THE DEVICE. RPTR STATED THAT THE PT WAS USED AS A "GUINEA PIG" AND WAS NOT ALLOWED TO DIE PEACEFULLY AND WITH DIGNITY. RPTR ALSO STATED THAT THE PT'S FAMILY ALSO SUFFERED AS A RESULT. RPTR STATED THEY WOULD NOT RECOMMEND ITS USE TO ANYONE AND THEY DESIRE THE FDA TO SET GUIDELINES CONCERNING ITS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC IMPLANTED INTERNAL HEART DEFIBRILLATOR LWS MEDTRONIC * 1D17E07

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death